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2026-09-09 23:52
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2026-09-09 18:17
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Neurocrine Biosciences, Inc. (NBIX) Presents at Wells Fargo 21st Annual Healthcare Conference Transcript | FMP Stock News | |
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2026-09-08 10:43
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2026-09-08 04:04
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Neurocrine Biosciences, Inc. $NBIX Shares Sold by Continuum Advisory LLC | FMP Stock News | |
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Continuum Advisory LLC decreased its position in shares of Neurocrine Biosciences, Inc. (NASDAQ:NBIX – Free Report) by 99.1% during the 2nd quarter, according to its most recent disclosure with the SEC. The firm owned 418 shares of the company’s stock after selling 43,650 shares during the period. Continuum Advisory LLC’s holdings in Neurocrine Biosciences were worth $70,000 as of its most recent SEC filing.Several other hedge funds and other institutional investors have also recently bought and sold shares of the company. Bank of America Corp DE raised its stake in Neurocrine Biosciences by 10.6% during the first quarter. Bank of America Corp DE now owns 583,827 shares of the company’s stock worth $76,913,000 after purchasing an additional 55,723 shares during the period. ABN AMRO Bank N.V. acquired a new stake in shares of Neurocrine Biosciences during the 2nd quarter worth $2,510,000. Fideuram Intesa Sanpaolo Private Banking S.P.A. acquired a new stake in shares of Neurocrine Biosciences during the 4th quarter worth $1,866,000. Cetera Investment Advisers boosted its holdings in Neurocrine Biosciences by 50.1% in the first quarter. Cetera Investment Advisers now owns 20,245 shares of the company’s stock valued at $2,667,000 after acquiring an additional 6,756 shares during the last quarter. Finally, SEB Asset Management AB purchased a new stake in Neurocrine Biosciences during the first quarter valued at about $10,483,000. 92.59% of the stock is owned by hedge funds and other institutional investors. Neurocrine Biosciences Price Performance NASDAQ:NBIX opened at $155.64 on Tuesday. The firm has a 50-day moving average of $165.70 and a two-hundred day moving average of $150.66. The stock has a market cap of $15.82 billion, a P/E ratio of 22.82, a PEG ratio of 0.73 and a beta of 0.38. Neurocrine Biosciences, Inc. has a 1-year low of $122.14 and a 1-year high of $186.12. Neurocrine Biosciences (NASDAQ:NBIX – Get Free Report) last announced its earnings results on Friday, July 31st. The company reported $2.85 earnings per share (EPS) for the quarter, topping analysts’ consensus estimates of $1.65 by $1.20. Neurocrine Biosciences had a return on equity of 22.43% and a net margin of 20.91%.The business had revenue of $959.00 million for the quarter, compared to analyst estimates of $891.16 million. During the same period in the previous year, the company earned $1.65 earnings per share. The company’s revenue for the quarter was up 39.5% compared to the same quarter last year. As a group, equities analysts expect that Neurocrine Biosciences, Inc. will post 7.25 earnings per share for the current year. Insider Buying and Selling at Neurocrine Biosciences In related news, insider Darin Lippoldt sold 10,000 shares of the company’s stock in a transaction on Thursday, July 9th. The shares were sold at an average price of $179.60, for a total value of $1,796,000.00. Following the sale, the insider directly owned 54,729 shares of the company’s stock, valued at $9,829,328.40. This represents a 15.45% decrease in their ownership of the stock. The transaction was disclosed in a legal filing with the SEC, which is accessible through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, Director Leslie Norwalk sold 1,250 shares of the stock in a transaction on Tuesday, July 28th. The shares were sold at an average price of $182.01, for a total transaction of $227,512.50. Following the transaction, the director owned 1,588 shares in the company, valued at $289,031.88. This trade represents a 44.05% decrease in their ownership of the stock. Additional details regarding this sale are available in the official SEC disclosure. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders have sold a total of 40,188 shares of company stock valued at $7,118,633 in the last three months. Corporate insiders own 4.60% of the company’s stock. Wall Street Analyst Weigh In Several research firms have recently weighed in on NBIX. Cantor Fitzgerald lifted their price objective on Neurocrine Biosciences from $210.00 to $215.00 and gave the company an “overweight” rating in a research note on Friday, July 31st. Zacks Research cut shares of Neurocrine Biosciences from a “strong-buy” rating to a “hold” rating in a research report on Tuesday, August 4th. Guggenheim increased their price objective on shares of Neurocrine Biosciences from $200.00 to $222.00 and gave the stock a “buy” rating in a research report on Friday, July 31st. Truist Financial raised their price objective on Neurocrine Biosciences from $200.00 to $213.00 and gave the company a “buy” rating in a research report on Monday, August 3rd. Finally, TD Cowen boosted their price objective on Neurocrine Biosciences from $200.00 to $220.00 and gave the stock a “buy” rating in a research note on Friday, July 31st. One research analyst has rated the stock with a Strong Buy rating, nineteen have assigned a Buy rating and four have given a Hold rating to the company’s stock. According to data from MarketBeat.com, the stock currently has an average rating of “Moderate Buy” and a consensus price target of $201.05. Check Out Our Latest Report on Neurocrine Biosciences Neurocrine Biosciences Company Profile (Free Report) Neurocrine Biosciences (NASDAQ: NBIX) is a biopharmaceutical company based in San Diego, California, focused on developing treatments for neurological, endocrine and neuropsychiatric disorders. Since its founding in 1992, the company has pursued a research‐driven strategy aimed at addressing unmet medical needs in movement disorders, reproductive health and central nervous system conditions. Neurocrine’s operations encompass drug discovery, clinical development and commercialization activities. The company’s lead marketed product, Ingrezza™ (valbenazine), is indicated for the treatment of tardive dyskinesia, a movement disorder associated with long-term antipsychotic use. Further Reading Five stocks we like better than Neurocrine Biosciences 3 Under-the-Radar Defense Stocks With Record Backlogs This Korea ETF Has Soared, But the Rally May Not Be Over Why Guidewire’s Post-Earnings Plunge May Not Last Ride-Share Reckoning: Tesla Drives Into Uber’s Lane Receive News & Ratings for Neurocrine Biosciences Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Neurocrine Biosciences and related companies with MarketBeat.com's FREE daily email newsletter. |
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Saved
2026-09-02 22:12
7d ago
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2026-09-02 16:01
7d ago
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Neurocrine Biosciences to Present at Upcoming Investor Conferences in September | FMP Stock News | |
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, /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that its executives will participate at the following investor conferences:Wells Fargo 21st Annual Healthcare Conference. Fireside chat on Wednesday, September 9, 2026 at 12:45 PM ET in Boston Cantor Global Healthcare Conference 2026. Fireside chat on Thursday, September 10, 2026 at 8:35 AM ET in New York Morgan Stanley 24th Annual Global Healthcare Conference. Fireside chat on Tuesday, September 15, 2026 at 10:45 AM ET in New York The webcasts can also be accessed on Neurocrine Biosciences' website under Investors at www.neurocrine.com. A replay of the webcasts will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month. About Neurocrine Biosciences Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. Contact: Neurocrine Biosciences, Inc. Tony Jewell (Media) 858-617-7578 [email protected] Todd Tushla (Investors) 858-617-7143 [email protected] SOURCE Neurocrine Biosciences, Inc. |
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2026-08-31 19:04
9d ago
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2026-08-31 13:36
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Neurocrine's Crenessity Gains Ground in CAH: How Far Can Sales Go? | FMP Stock News | |
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Key Takeaways Crenessity sales hit $337 million in the first half of 2026, up roughly 400% year over year.About 15% of diagnosed classic CAH patients have been prescribed Crenessity, leaving room to expand.Vertex's planned $10 billion Crinetics deal could strengthen a key rival currently advancing phase III. Neurocrine Biosciences (NBIX - Free Report) continues to rely heavily on its blockbuster VMAT2 inhibitor, Ingrezza, for top-line growth. Still, the company is making meaningful progress beyond the drug as Crenessity gains traction in classic congenital adrenal hyperplasia (CAH), a rare genetic condition involving the adrenal glands.Launched in December 2024, Crenessity is an oral therapy designed to reduce excessive adrenal androgen production and, in turn, help lower the amount of glucocorticoid (steroid) treatment needed. The drug is emerging as an increasingly important contributor to Neurocrine's commercial portfolio. Crenessity generated $337 million in sales during the first half of 2026, up roughly 400% year over year and surpassing the $301 million generated in 2025. The strong performance was supported by growing adoption among adult and pediatric patients, with Neurocrine's prescriber base nearly tripling from a year ago. The rapid uptake highlights the drug's increasing contribution to Neurocrine's revenue base and its potential to become a meaningful growth driver alongside Ingrezza. Neurocrine has not yet provided sales guidance for Crenessity, as the launch remains relatively early and the company continues to learn more about the market and the drug's growth trajectory. About 15% of the estimated diagnosed classic CAH population has now been prescribed the drug, while Neurocrine estimates that at least 20,000 people in the United States have classic CAH. This low penetration leaves substantial room for further adoption and sales expansion. Meanwhile, reimbursement for dispensed prescriptions was approximately 80% in the second quarter, and Neurocrine continues to broaden its reach among pediatric and adult endocrinologists and Centers of Excellence. Competition Could Pose a Concern for NBIX Over TimeCrenessity's growing presence in the CAH market could face increasing competition from Crinetics Pharmaceuticals’ (CRNX - Free Report) atumelnant, a once-daily oral ACTH receptor antagonist. The drug is currently being evaluated in a phase III study for classic CAH. The competitive threat is becoming more notable following Vertex Pharmaceuticals' (VRTX - Free Report) agreement to acquire CRNX for $10 billion. Announced last month, the deal would bring atumelnant into Vertex's portfolio, providing the candidate with the resources of a larger pharmaceutical company as it advances through late-stage development. The transaction is expected to close in the third quarter of 2026. Other companies, including Lundbeck Pharmaceuticals and OMass Therapeutics, are also developing potential CAH therapies, though their programs are at earlier stages of development. NBIX’s Price Performance, Valuation & EstimatesShares of Neurocrine Biosciences have outperformed the industry year to date, as seen in the chart below. Image Source: Zacks Investment Research The company is currently trading at a premium to the industry. Based on the price-to-sales (P/S) ratio, the stock trades at 3.64 times forward 12-month sales, above the industry average of 2.04 times. Image Source: Zacks Investment Research Estimate revisions for Neurocrine Biosciences’ 2026 and 2027 EPS have been mixed over the past 30 days. Image Source: Zacks Investment Research Neurocrine currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. |
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2026-08-24 10:02
16d ago
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2026-08-24 03:57
17d ago
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B. Metzler seel. Sohn & Co. AG Acquires New Shares in Neurocrine Biosciences, Inc. $NBIX | FMP Stock News | |
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B. Metzler seel. Sohn & Co. AG acquired a new stake in shares of Neurocrine Biosciences, Inc. (NASDAQ:NBIX – Free Report) during the second quarter, according to its most recent filing with the Securities & Exchange Commission. The firm acquired 5,986 shares of the company’s stock, valued at approximately $1,009,000.Other institutional investors and hedge funds also recently added to or reduced their stakes in the company. Geneos Wealth Management Inc. raised its stake in shares of Neurocrine Biosciences by 143.6% during the 1st quarter. Geneos Wealth Management Inc. now owns 229 shares of the company’s stock worth $25,000 after acquiring an additional 135 shares in the last quarter. DJE Kapital AG purchased a new position in Neurocrine Biosciences in the 4th quarter worth $28,000. Basecamp Wealth Advisors LLC lifted its holdings in shares of Neurocrine Biosciences by 582.9% during the first quarter. Basecamp Wealth Advisors LLC now owns 239 shares of the company’s stock worth $31,000 after purchasing an additional 204 shares during the period. Cassaday & Co Wealth Management LLC acquired a new stake in Neurocrine Biosciences during the 1st quarter valued at approximately $33,000. Finally, Meeder Asset Management Inc. boosted its holdings in Neurocrine Biosciences by 651.6% in the fourth quarter. Meeder Asset Management Inc. now owns 233 shares of the company’s stock valued at $33,000 after purchasing an additional 202 shares during the last quarter. Hedge funds and other institutional investors own 92.59% of the company’s stock. Insiders Place Their Bets In other news, Director Stephen A. Sherwin sold 25,000 shares of the business’s stock in a transaction that occurred on Friday, June 5th. The stock was sold at an average price of $165.32, for a total transaction of $4,133,000.00. Following the sale, the director owned 15,860 shares of the company’s stock, valued at $2,621,975.20. The trade was a 61.18% decrease in their position. The sale was disclosed in a legal filing with the Securities & Exchange Commission, which is available through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, insider Ingrid Delaet sold 4,367 shares of the company’s stock in a transaction that occurred on Friday, July 10th. The shares were sold at an average price of $181.02, for a total value of $790,514.34. Following the completion of the sale, the insider directly owned 16,225 shares in the company, valued at approximately $2,937,049.50. The trade was a 21.21% decrease in their position. The SEC filing for this sale provides additional information. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders have sold 131,524 shares of company stock valued at $21,668,924 in the last three months. 4.60% of the stock is owned by corporate insiders. Analyst Upgrades and Downgrades NBIX has been the topic of several recent research reports. Wells Fargo & Company upped their price objective on Neurocrine Biosciences from $175.00 to $200.00 and gave the stock an “overweight” rating in a research report on Friday, July 17th. Piper Sandler boosted their price target on Neurocrine Biosciences from $207.00 to $210.00 and gave the stock an “overweight” rating in a research report on Friday, July 31st. Sanford C. Bernstein started coverage on shares of Neurocrine Biosciences in a report on Friday, May 22nd. They issued an “outperform” rating and a $221.00 price objective for the company. JPMorgan Chase & Co. boosted their price target on shares of Neurocrine Biosciences from $177.00 to $185.00 and gave the company an “overweight” rating in a research report on Friday, May 8th. Finally, Stifel Nicolaus increased their price objective on Neurocrine Biosciences from $188.00 to $215.00 and gave the stock a “buy” rating in a research report on Friday, July 31st. One research analyst has rated the stock with a Strong Buy rating, nineteen have assigned a Buy rating and four have issued a Hold rating to the company. Based on data from MarketBeat, Neurocrine Biosciences has a consensus rating of “Moderate Buy” and an average price target of $200.86. View Our Latest Research Report on NBIX Neurocrine Biosciences Stock Performance Shares of NASDAQ NBIX opened at $152.57 on Monday. The firm has a market capitalization of $15.51 billion, a PE ratio of 22.37, a price-to-earnings-growth ratio of 0.71 and a beta of 0.39. Neurocrine Biosciences, Inc. has a fifty-two week low of $122.14 and a fifty-two week high of $186.12. The stock’s 50-day simple moving average is $167.14 and its 200-day simple moving average is $148.96. Neurocrine Biosciences (NASDAQ:NBIX – Get Free Report) last issued its quarterly earnings data on Friday, July 31st. The company reported $2.85 earnings per share (EPS) for the quarter, topping the consensus estimate of $1.65 by $1.20. The company had revenue of $959.00 million for the quarter, compared to analyst estimates of $891.16 million. Neurocrine Biosciences had a return on equity of 22.43% and a net margin of 20.91%.The business’s quarterly revenue was up 39.5% compared to the same quarter last year. During the same quarter last year, the company posted $1.65 earnings per share. On average, sell-side analysts forecast that Neurocrine Biosciences, Inc. will post 7.25 earnings per share for the current fiscal year. (Free Report) Neurocrine Biosciences (NASDAQ: NBIX) is a biopharmaceutical company based in San Diego, California, focused on developing treatments for neurological, endocrine and neuropsychiatric disorders. Since its founding in 1992, the company has pursued a research‐driven strategy aimed at addressing unmet medical needs in movement disorders, reproductive health and central nervous system conditions. Neurocrine’s operations encompass drug discovery, clinical development and commercialization activities. The company’s lead marketed product, Ingrezza™ (valbenazine), is indicated for the treatment of tardive dyskinesia, a movement disorder associated with long-term antipsychotic use. Featured Stories Five stocks we like better than Neurocrine Biosciences VIG, VYM, and VYMI: Which Vanguard Dividend ETF Is Right for You? 3 Closed-End Funds to Maximize Dividend Payments Rocket Lab’s Sell-Off Is Fading—Is It Finally Safe to Buy? $27 Billion in Buybacks: 3 Stocks Betting Their Strong Runs Aren’t Over Want to see what other hedge funds are holding NBIX? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Neurocrine Biosciences, Inc. (NASDAQ:NBIX – Free Report). Receive News & Ratings for Neurocrine Biosciences Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Neurocrine Biosciences and related companies with MarketBeat.com's FREE daily email newsletter. |
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Saved
2026-08-22 09:47
18d ago
Published
2026-08-22 03:07
19d ago
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Allworth Financial LP Invests $2.50 Million in Neurocrine Biosciences, Inc. $NBIX | FMP Stock News | |
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Allworth Financial LP purchased a new position in shares of Neurocrine Biosciences, Inc. (NASDAQ:NBIX – Free Report) during the 2nd quarter, according to the company in its most recent filing with the Securities and Exchange Commission. The firm purchased 14,853 shares of the company’s stock, valued at approximately $2,503,000.A number of other hedge funds have also added to or reduced their stakes in the company. B. Metzler seel. Sohn & Co. AG bought a new position in Neurocrine Biosciences in the second quarter valued at about $1,009,000. TrinityBridge Ltd bought a new position in shares of Neurocrine Biosciences in the second quarter worth about $45,000. Virtus Advisers LLC acquired a new stake in shares of Neurocrine Biosciences in the 2nd quarter valued at approximately $457,000. Silvant Capital Management LLC acquired a new stake in shares of Neurocrine Biosciences in the 2nd quarter valued at approximately $3,490,000. Finally, Advisors Preferred LLC acquired a new stake in shares of Neurocrine Biosciences in the 2nd quarter valued at approximately $5,415,000. 92.59% of the stock is owned by institutional investors. Insider Activity In related news, Director Stephen A. Sherwin sold 25,000 shares of Neurocrine Biosciences stock in a transaction on Friday, June 5th. The shares were sold at an average price of $165.32, for a total transaction of $4,133,000.00. Following the completion of the transaction, the director owned 15,860 shares of the company’s stock, valued at $2,621,975.20. This trade represents a 61.18% decrease in their ownership of the stock. The sale was disclosed in a filing with the Securities & Exchange Commission, which is available at the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, insider Darin Lippoldt sold 10,000 shares of the business’s stock in a transaction on Thursday, July 9th. The shares were sold at an average price of $179.60, for a total transaction of $1,796,000.00. Following the completion of the transaction, the insider owned 54,729 shares in the company, valued at approximately $9,829,328.40. The trade was a 15.45% decrease in their position. The disclosure for this sale is available in the SEC filing. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. In the last 90 days, insiders sold 131,524 shares of company stock valued at $21,668,924. Company insiders own 4.60% of the company’s stock. Neurocrine Biosciences Price Performance Shares of NBIX opened at $152.57 on Friday. Neurocrine Biosciences, Inc. has a 1 year low of $122.14 and a 1 year high of $186.12. The company has a market capitalization of $15.51 billion, a price-to-earnings ratio of 22.37, a price-to-earnings-growth ratio of 0.71 and a beta of 0.39. The business has a 50-day moving average of $167.14 and a 200-day moving average of $148.88. Neurocrine Biosciences (NASDAQ:NBIX – Get Free Report) last posted its quarterly earnings data on Friday, July 31st. The company reported $2.85 EPS for the quarter, topping analysts’ consensus estimates of $1.65 by $1.20. Neurocrine Biosciences had a return on equity of 22.43% and a net margin of 20.91%.The company had revenue of $959.00 million for the quarter, compared to analyst estimates of $891.16 million. During the same period in the previous year, the firm earned $1.65 earnings per share. The firm’s quarterly revenue was up 39.5% on a year-over-year basis. As a group, sell-side analysts anticipate that Neurocrine Biosciences, Inc. will post 7.25 EPS for the current year. Wall Street Analysts Forecast Growth NBIX has been the subject of a number of research analyst reports. Royal Bank Of Canada upped their price objective on shares of Neurocrine Biosciences from $195.00 to $198.00 and gave the stock an “outperform” rating in a research report on Friday, July 31st. Wedbush raised their target price on shares of Neurocrine Biosciences from $185.00 to $194.00 and gave the company an “outperform” rating in a research report on Monday, August 3rd. Canaccord Genuity Group boosted their target price on shares of Neurocrine Biosciences from $200.00 to $210.00 and gave the stock a “buy” rating in a research note on Monday, August 3rd. Weiss Ratings downgraded shares of Neurocrine Biosciences from a “buy (b)” rating to a “buy (b-)” rating in a report on Tuesday, August 11th. Finally, TD Cowen increased their price target on Neurocrine Biosciences from $200.00 to $220.00 and gave the company a “buy” rating in a research note on Friday, July 31st. One analyst has rated the stock with a Strong Buy rating, nineteen have given a Buy rating and four have given a Hold rating to the stock. According to MarketBeat, the company has an average rating of “Moderate Buy” and an average price target of $200.86. Check Out Our Latest Stock Analysis on NBIX (Free Report) Neurocrine Biosciences (NASDAQ: NBIX) is a biopharmaceutical company based in San Diego, California, focused on developing treatments for neurological, endocrine and neuropsychiatric disorders. Since its founding in 1992, the company has pursued a research‐driven strategy aimed at addressing unmet medical needs in movement disorders, reproductive health and central nervous system conditions. Neurocrine’s operations encompass drug discovery, clinical development and commercialization activities. The company’s lead marketed product, Ingrezza™ (valbenazine), is indicated for the treatment of tardive dyskinesia, a movement disorder associated with long-term antipsychotic use. Recommended Stories Five stocks we like better than Neurocrine Biosciences Blueprint for a Boom: SEC Clears the Crypto Runway Ross Stores Just Flipped the Off-Price Retail Story After TJX’s Marmaxx Miss Advance Auto Parts Plunged, But Its Turnaround Is Still Working Is Palo Alto Networks Priced for Perfection Again as AI Security Demand Accelerates? Receive News & Ratings for Neurocrine Biosciences Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Neurocrine Biosciences and related companies with MarketBeat.com's FREE daily email newsletter. |
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2026-08-22 07:22
18d ago
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2026-08-22 02:57
19d ago
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Neurocrine Biosciences: 'House Full Of Options' | FMP Stock News | |
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SummaryNeurocrine Biosciences is rated a 'Buy' based on robust cash flows, strong product launches, and a deep, diversified pipeline.Ingrezza anchors NBIX's profitability, with exclusivity until 2038 and projected peak sales of $3.3B, while Crenessity and Vykat XR add growth pillars.Valuation models yield $224/share (DCF) and $167/share (with all research costs), both above recent market prices, highlighting undervaluation.Pipeline optionality is significant but hard to quantify; even with conservative assumptions, current business fundamentals justify a bullish stance. Daniel Grizelj/DigitalVision via Getty ImagesIntroduction Neurocrine Biosciences, Inc. (NBIX) is a San Diego-based neuroscience and endocrinology company that has crossed from one-product dependency to three marketed medicines. The research pipeline is very deep, with 2 indications advanced in phase 3 and multiple at lower stages 70 Followers Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body. |
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2026-08-20 16:33
20d ago
Published
2026-08-20 12:16
20d ago
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Is NBIX Stock a Buy as Fast Growth Meets a Premium Sales Valuation? | FMP Stock News | |
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Key Takeaways Neurocrine's revenue rose 39% in Q2, while adjusted EPS jumped 73%, beating consensus estimates.Crenessity sales surged about 400%, while Vykat XR adds another rare-disease growth pillar.NBIX trades at a premium sales multiple, with Ingrezza dependence and pipeline risks warranting caution. Neurocrine Biosciences, Inc. (NBIX - Free Report) is pairing rapid earnings and revenue growth with a broader rare-disease portfolio. That operating momentum gives investors a clear fundamental reason to watch the stock.The trade-off is valuation and execution. NBIX sells at a premium to its sub-industry and the Medical sector on forward sales, while product concentration, competition and pipeline risk argue for a measured view. NBIX Growth Still Looks StrongSecond-quarter 2026 revenues rose 39% year over year to $959 million, while adjusted earnings advanced 73% to $2.85 per share. The results beat the Zacks Consensus Estimate for earnings of $2.26 per share and for revenues of $901.5 million. The growth outlook remains elevated. Projected 2026 sales growth is 35.8%, while projected EPS growth is 41.9%. Ingrezza remains the main engine, with first-half 2026 sales up 17% to $1.4 billion and full-year guidance raised to $2.825-$2.875 billion. Neurocrine Diversifies Beyond IngrezzaCrenessity is becoming a meaningful second growth pillar. First-half 2026 sales reached $337 million, up about 400% year over year and already above the $301 million generated in all of 2025. Vykat XR adds another rare-disease asset following the Soleno Therapeutics acquisition. It contributed $54 million from May 18 through the end of the second quarter. Management expects launch-related discontinuation effects to largely work through during the third quarter, with sequential sales growth anticipated from the fourth quarter onward. NBIX Valuation Demands a Closer LookNBIX trades at a forward 12-month price-to-sales ratio of 3.69, versus 2.02 for its sub-industry and 2.23 for the Medical sector. That premium means investors are already paying for faster growth and successful diversification. The stock still trades below its five-year median forward sales multiple of 5.18. A forward price-to-earnings ratio of 17.15 and PEG ratio of 0.56 make the valuation picture less one-dimensional, but they do not remove the need for continued execution. Neurocrine Still Faces Execution RisksIngrezza remains the dominant revenue contributor and is exposed to pricing, formulary and policy pressure. Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) markets Austedo and Austedo XR for tardive dyskinesia and chorea associated with Huntington's disease, directly overlapping with Ingrezza's approved markets. A lower negotiated Medicare price for Austedo beginning in 2027 could add pressure on Ingrezza. Vykat XR also carries retention risk, with management expecting a long-term discontinuation rate of 25-30%. Pipeline execution is another concern after recent clinical setbacks. Bristol Myers Squibb Company (BMY - Free Report) markets Cobenfy for schizophrenia, adding a newer competitor in a market where Neurocrine is advancing phase III candidate direclidine. NBIX's Mixed Signals Support a Measured ViewFor investors weighing buy, hold or wait, NBIX presents a mixed setup. Growth, diversification and a debt-free balance sheet support the long-term story, but the premium sales valuation, Ingrezza dependence and product-development risks reduce the case for ignoring entry discipline. The stock currently carries a Zacks Rank #3 (Hold). It also has a Growth Score of A, Value Score of B, Momentum Score of D and VGM Score of A. The Style Scores show favorable growth and value characteristics, but the weak Momentum Score and Zacks Rank #3 make the setup more consistent with a hold-or-wait posture than an aggressive buy case. |
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2026-08-20 16:33
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2026-08-20 12:21
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Can NBIX's Q2 Beat and Higher Ingrezza Guidance Drive More Growth? | FMP Stock News | |
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Key Takeaways Neurocrine posted 39% revenue growth and a 73% rise in adjusted EPS in Q2.Ingrezza sales rose 15%, prompting Neurocrine to raise its 2026 sales guidance to $2.825-$2.875 billion.Crenessity and Vykat XR are broadening growth, while higher R&D and SG&A spending adds pressure. Neurocrine Biosciences (NBIX - Free Report) delivered a better-than-expected second quarter, with revenues and adjusted earnings per share topping the Zacks Consensus Estimate. The company also raised its 2026 Ingrezza sales outlook, reinforcing the role of its flagship therapy in near-term growth.The next test is whether prescription momentum, Crenessity's launch and Vykat XR can keep widening the revenue base as research and commercial spending rises. That balance matters because Ingrezza remains Neurocrine's main revenue engine even as newer products broaden the portfolio. NBIX Delivers a Strong Q2 BeatSecond-quarter revenues increased 39% year over year to $959 million, above the Zacks Consensus Estimate of $901.5 million. Adjusted earnings of $2.85 per share rose 73% and beat the consensus estimate of $2.26. The beat was broad-based. Ingrezza sales reached $716 million versus the $628.6 million consensus mark, while Crenessity generated $184 million compared with the $170.8 million estimate. Vykat XR added $54 million from May 18 through quarter-end, giving Neurocrine contributions from all three marketed therapies. Neurocrine Raises the Bar for IngrezzaIngrezza sales increased 15% in the second quarter and 17% in the first half of 2026 to $1.4 billion. Neurocrine cited double-digit prescription volume growth, record new prescriptions and continued access covering about 70% of Medicare lives. Management raised 2026 Ingrezza net product sales guidance to $2.825-$2.875 billion from $2.7-$2.8 billion, implying roughly 13% growth at the midpoint. Neurocrine estimates that tardive dyskinesia affects about 800,000 U.S. patients, with roughly 10% receiving a VMAT2 inhibitor. Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) markets competing Austedo and Austedo XR in tardive dyskinesia and Huntington's disease chorea. NBIX Adds Rare-Disease Growth EnginesCrenessity generated $337 million in first-half 2026 sales, up about 400% year over year and already above its $301 million total for 2025. About 15% of the estimated diagnosed classic congenital adrenal hyperplasia population has been prescribed the drug, and its prescriber base has nearly tripled. Vykat XR contributed $54 million in reported second-quarter sales after the Soleno acquisition closed in May, while unaudited pro forma full-quarter sales were $94 million. Neurocrine expects launch-related discontinuations to largely work through during the third quarter and anticipates sequential sales growth beginning in the fourth quarter. Neurocrine Is Spending More To ScaleAdjusted research and development expenses rose 24% to $276.1 million, reflecting investment across a broader development portfolio. Adjusted selling, general and administrative expenses increased 20% to $304.9 million as Neurocrine expanded commercial support for Ingrezza, Crenessity and Vykat XR. The company also raised 2026 adjusted research and development guidance to $1.14-$1.19 billion and selling, general and administrative guidance to $1.325-$1.35 billion. Bristol Myers Squibb (BMY - Free Report) already markets Cobenfy for adults with schizophrenia, a market relevant to Neurocrine's phase III direclidine program and its expanding research investment. NBIX Signals Temper Q2 OptimismThe second-quarter beat, higher Ingrezza guidance and growing rare-disease portfolio support the revenue story, but higher operating investment and execution risks keep the outlook balanced. Vykat XR retention, Ingrezza pricing exposure and pipeline delivery remain important variables as Neurocrine scales. NBIX currently carries a Zacks Rank #3 (Hold), which is less favorable than the #1 and 2 (Buy) ranks that Zacks Style Scores are designed to complement most effectively. Its Growth Score of A and VGM Score of A indicate favorable growth and blended style characteristics, while its Value Score of B is also constructive. The Momentum Score of D points to weaker momentum characteristics, tempering the otherwise favorable Style Score mix. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. |
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2026-08-20 16:33
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2026-08-20 12:26
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Neurocrine's Ingrezza Sales Keep Growing: Can the Momentum Last? | FMP Stock News | |
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Key Takeaways Neurocrine's Ingrezza sales rose 17% to $1.4 billion in the first half of 2026.Record new prescriptions and double-digit volume growth drove a higher 2026 Ingrezza sales outlook.Austedo's growth and potential pricing pressure could challenge Ingrezza's momentum over time. Neurocrine Biosciences (NBIX - Free Report) has had an encouraging start so far in 2026, with strong revenue growth, supported by continued momentum in its commercial portfolio. The top-line benefits primarily from Ingrezza, the company's blockbuster VMAT2 inhibitor, which remains Neurocrine’s primary revenue driver and a key pillar of its growth story.Ingrezza sales rose 17% year over year to $1.4 billion in the first half of 2026, supported by record new prescriptions and double-digit total volume growth. The strong performance prompted management to raise its Ingrezza sales guidance for full-year 2026 to $2.83-$2.88 billion from $2.7-$2.8 billion. The midpoint implies approximately 13% year-over-year growth, indicating that Neurocrine expects the drug's commercial momentum to remain solid through the remainder of the year. Ingrezza is approved for two indications — tardive dyskinesia (TD) and chorea associated with Huntington's disease (HD). However, TD represents the larger commercial opportunity for Ingrezza. Neurocrine estimates that roughly 800,000 people in the United States are affected by the disease, yet only about half are diagnosed and approximately 10% receive a VMAT2 inhibitor, highlighting the significant room for broader treatment adoption. Continued diagnosis and treatment penetration could therefore support Ingrezza's sales growth even as the drug's existing patient base expands. In comparison, chorea affects the vast majority of the roughly 40,000 Americans living with HD. Although the addressable population is considerably smaller than that for TD, the indication provides an additional source of demand and strengthens Ingrezza's position across the movement-disorder market. Pricing Exposure Could Become a Concern for NBIX Over TimeWhile Ingrezza continues to benefit from strong volume growth, pricing remains an important consideration for its future sales trajectory. In 2025, pricing concessions related to broader formulary access partially offset volume gains. Although management expects 2026 net pricing to remain broadly consistent with last year's levels, pricing pressure is expected to rise in the longer term. A key factor could be the pricing of Teva Pharmaceuticals' (TEVA - Free Report) Austedo and Austedo XR, which compete with Ingrezza across both approved indications. TEVA’s therapies are set to enter the Medicare Drug Price Negotiation Program in 2027, with negotiated prices below pre-negotiation levels. This could make Austedo/Austedo XR more price-competitive among Medicare patients and potentially put additional pressure on Ingrezza's pricing and formulary positioning. Neurocrine has said it remains confident in maintaining broad access for Ingrezza, although greater pricing competition could become a concern over time. At the same time, Austedo is gaining momentum in the market. Teva reported second-quarter 2026 Austedo sales of $696 million, up 40% year over year, underscoring the drug's growing competitive position. Like NBIX, TEVA also raised its 2026 outlook for Austedo to $2.45-$2.60 billion from $2.40-$2.55 billion. While Austedo remains the most direct competitive threat, the pipeline is also evolving beyond VMAT2 inhibitors. Acadia Pharmaceuticals (ACAD - Free Report) recently started clinical development on ACP-271, a GPR88 agonist for TD. Though this candidate is still in early-stage development, its different mechanism could represent a longer-term competitive consideration for Ingrezza. NBIX’s Price Performance, Valuation & EstimatesShares of Neurocrine Biosciences have outperformed the industry year to date, as seen in the chart below. Image Source: Zacks Investment Research The company is currently trading at a premium to the industry. Based on the price-to-sales (P/S) ratio, the stock trades at 3.69 times forward 12-month sales, above the industry average of 2.02 times. Image Source: Zacks Investment Research Estimate revisions for Neurocrine Biosciences’ 2026 and 2027 EPS have been mixed over the past 30 days. Image Source: Zacks Investment Research Neurocrine currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. |
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2026-08-20 11:37
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2026-08-20 04:03
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BlackRock Inc. Takes $2.31 Billion Position in Neurocrine Biosciences, Inc. $NBIX | FMP Stock News | |
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BlackRock Inc. purchased a new stake in shares of Neurocrine Biosciences, Inc. (NASDAQ:NBIX – Free Report) during the 2nd quarter, according to the company in its most recent filing with the Securities & Exchange Commission. The fund purchased 13,711,607 shares of the company’s stock, valued at approximately $2,310,886,000. BlackRock Inc. owned 13.49% of Neurocrine Biosciences at the end of the most recent reporting period.A number of other institutional investors also recently bought and sold shares of NBIX. Pallas Capital Advisors LLC purchased a new stake in Neurocrine Biosciences in the second quarter worth about $1,561,000. Deutsche Bank AG purchased a new position in shares of Neurocrine Biosciences during the 2nd quarter worth approximately $56,402,000. Rice Hall James & Associates LLC purchased a new position in shares of Neurocrine Biosciences during the 2nd quarter worth approximately $16,886,000. Mitsubishi UFJ Asset Management Co. Ltd. purchased a new position in shares of Neurocrine Biosciences during the 2nd quarter worth approximately $18,789,000. Finally, Persistent Asset Partners Ltd bought a new position in shares of Neurocrine Biosciences in the 2nd quarter worth approximately $74,000. 92.59% of the stock is owned by institutional investors. Wall Street Analysts Forecast Growth NBIX has been the topic of several research reports. BMO Capital Markets lifted their price target on Neurocrine Biosciences from $144.00 to $170.00 and gave the company a “market perform” rating in a research report on Monday, July 13th. JPMorgan Chase & Co. increased their price objective on Neurocrine Biosciences from $177.00 to $185.00 and gave the stock an “overweight” rating in a report on Friday, May 8th. Guggenheim raised their price objective on Neurocrine Biosciences from $200.00 to $222.00 and gave the company a “buy” rating in a research report on Friday, July 31st. Wedbush boosted their target price on shares of Neurocrine Biosciences from $185.00 to $194.00 and gave the company an “outperform” rating in a report on Monday, August 3rd. Finally, TD Cowen upped their target price on shares of Neurocrine Biosciences from $200.00 to $220.00 and gave the stock a “buy” rating in a research report on Friday, July 31st. One investment analyst has rated the stock with a Strong Buy rating, nineteen have issued a Buy rating and four have issued a Hold rating to the company. According to MarketBeat, the stock currently has an average rating of “Moderate Buy” and a consensus price target of $200.86. Read Our Latest Stock Analysis on NBIX Insider Buying and Selling In other news, Director Stephen A. Sherwin sold 25,000 shares of the firm’s stock in a transaction on Friday, June 5th. The stock was sold at an average price of $165.32, for a total transaction of $4,133,000.00. Following the completion of the transaction, the director directly owned 15,860 shares in the company, valued at $2,621,975.20. This trade represents a 61.18% decrease in their ownership of the stock. The sale was disclosed in a legal filing with the Securities & Exchange Commission, which is available through the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, Director Leslie V. Norwalk sold 1,250 shares of the firm’s stock in a transaction on Tuesday, July 28th. The shares were sold at an average price of $182.01, for a total value of $227,512.50. Following the transaction, the director owned 1,588 shares of the company’s stock, valued at $289,031.88. The trade was a 44.05% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. In the last three months, insiders sold 131,524 shares of company stock valued at $21,668,924. Insiders own 4.60% of the company’s stock. Neurocrine Biosciences Stock Up 0.8% Shares of NBIX opened at $155.54 on Thursday. The stock has a market cap of $15.81 billion, a P/E ratio of 22.81, a P/E/G ratio of 0.72 and a beta of 0.39. The business’s 50 day moving average price is $167.48 and its 200-day moving average price is $148.73. Neurocrine Biosciences, Inc. has a 52 week low of $122.14 and a 52 week high of $186.12. Neurocrine Biosciences (NASDAQ:NBIX – Get Free Report) last posted its quarterly earnings data on Friday, July 31st. The company reported $2.85 earnings per share for the quarter, beating analysts’ consensus estimates of $1.65 by $1.20. The company had revenue of $959.00 million during the quarter, compared to analyst estimates of $891.16 million. Neurocrine Biosciences had a return on equity of 22.43% and a net margin of 20.91%.The firm’s revenue for the quarter was up 39.5% on a year-over-year basis. During the same quarter last year, the company earned $1.65 EPS. On average, equities analysts anticipate that Neurocrine Biosciences, Inc. will post 7.25 EPS for the current year. Neurocrine Biosciences Company Profile (Free Report) Neurocrine Biosciences (NASDAQ: NBIX) is a biopharmaceutical company based in San Diego, California, focused on developing treatments for neurological, endocrine and neuropsychiatric disorders. Since its founding in 1992, the company has pursued a research‐driven strategy aimed at addressing unmet medical needs in movement disorders, reproductive health and central nervous system conditions. Neurocrine’s operations encompass drug discovery, clinical development and commercialization activities. The company’s lead marketed product, Ingrezza™ (valbenazine), is indicated for the treatment of tardive dyskinesia, a movement disorder associated with long-term antipsychotic use. Featured Articles Five stocks we like better than Neurocrine Biosciences Bloom Energy’s AI Surge Meets a Valuation Reality Check Target Is Winning Shoppers Back—Can the Rally Reach $180? IonQ’s Space Contract Points to a New Frontier for Quantum Investors Is Apple’s AI Strategy Smarter Than Skeptics Think? Want to see what other hedge funds are holding NBIX? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Neurocrine Biosciences, Inc. (NASDAQ:NBIX – Free Report). Receive News & Ratings for Neurocrine Biosciences Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Neurocrine Biosciences and related companies with MarketBeat.com's FREE daily email newsletter. |
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2026-08-17 15:54
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2026-08-17 11:41
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NBIX Stock Dips 12% in a Month: Time to Buy, Hold or Sell? | FMP Stock News | |
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Neurocrine's shares fell 12% in a month as Vykat XR safety concerns mount, but Ingrezza and Crenessity support growth. |
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2026-08-17 01:24
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2026-08-16 04:11
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14,787 Shares in Neurocrine Biosciences, Inc. $NBIX Purchased by ABN AMRO Bank N.V. | FMP Stock News | |
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ABN AMRO Bank N.V. bought a new position in shares of Neurocrine Biosciences, Inc. (NASDAQ: NBIX) during the undefined quarter, according to its most recent 13F filing with the Securities and Exchange Commission (SEC). The institutional investor bought 14,787 shares of the company's stock, valued at approximately $2,510,000. Other hedge funds also recently |
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2026-08-12 17:54
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2026-08-12 11:57
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What's Going On With Neurocrine Biosciences Stock On Wednesday? | FMP Stock News | |
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Neurocrine Biosciences Inc. (NASDAQ:NBIX) stock fell almost 5% on Wednesday before recovering after physicians and experts in Prader-Willi syndrome notified clinicians of some cases of deaths and severe complications potentially associated with Vykat XR (diazoxide choline).The San Diego-based company added Vykat after acquiring Soleno Therapeutics Inc. for $53 per share in cash, totaling approximately $2.9 billion. The acquisition aimed to expand Neurocrine’s portfolio with Vykat XR, the first FDA-approved treatment for hyperphagia in Prader-Willi syndrome, which could significantly enhance its revenue potential as the company strengthens its position in the endocrinology and rare disease markets. The FDA approved the drug in 2025 to manage hyperphagia in PWS patients four years and older; the medication carries warnings regarding edema and fluid overload. Read Next Seven Deaths Reported In FDA Adverse Event DataAccording to data from the FDA Adverse Event Monitoring System as of July 31, 2026, there have been seven reported deaths and more than 100 serious adverse events, primarily involving edema, respiratory, and cardiac issues. Individuals facing these adverse outcomes frequently had complex medical histories, pre-existing obesity, and multiple concurrent medications. While the reports cannot definitively prove whether Vykat XR directly caused these incidents, doctors note that baseline PWS mortality ranges between 1% and 3% annually. Certain underlying conditions appear to elevate safety risks during treatment initiation or dose adjustment. These key factors include severe obesity, heart problems, pre-existing fluid retention, severe breathing difficulties, untreated sleep apnea, and a history of severe respiratory infections. Q2 Sales of $54 MillionVykat XR second-quarter 2026 net product sales were $54 million from May 18, 2026, the closing date of the Soleno acquisition. Unaudited pro forma full-quarter net product sales were $94 million. Healthcare providers considering this therapy should conduct comprehensive individual assessments before initiating treatment. Recommended measures include conducting baseline testing, such as echocardiograms, and monitoring for fluid retention. Physicians are urged to consider slowing the drug’s titration process and carefully watching for warning symptoms like rapid weight gain, dyspnea, orthopnea, or worsening edema. NBIX Stock Price Activity: Neurocrine Biosciences shares were down 2.07% at $159.63 at the time of publication on Wednesday, according to Benzinga Pro data. Read Next Photo: Shutterstock Market News and Data brought to you by Benzinga APIs © 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved. To add Benzinga News as your preferred source on Google, click here. |
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2026-08-12 13:05
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2026-08-12 07:12
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Prader-Willi experts flag safety risks linked to Neurocrine's rare disease drug | FMP Stock News | |
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The offices of Neurocrine Biosciences in San Diego, California, U.S. June 30, 2026. REUTERS/Mike Blake Purchase Licensing Rights, opens new tabCompaniesAug 12 (Reuters) - Experts in Prader-Willi Syndrome on Tuesday raised safety concerns over Neurocrine's (NBIX.O), opens new tab drug Vykat XR, citing serious adverse events reported in patients with the rare genetic disorder. Vykat XR was approved last year to treat hyperphagia or feelings of intense and persistent hunger, the hallmark symptom of Prader-Willi syndrome, a genetic disorder caused by deletions on chromosome 15 that affect gene expression, or how genes turn on and off. Jumpstart your morning with the latest legal news delivered straight to your inbox from The Daily Docket newsletter. Sign up here. In a joint statement, Foundation for Prader-Willi Research and the International Prader-Willi Syndrome Organisation said serious adverse events - including edema, respiratory complications and cardiac complications - had been reported through post-marketing surveillance since Vykat XR became more widely available. Neurocrine shares fell 6.1% in premarket trading on Wednesday. According to the statement, the U.S. Food and Drug Administration's Adverse Event Monitoring System (AEMS) showed seven reports of death linked to patients taking the drug as of July 31. Peripheral edema and the drug being ineffective were the highest reported reactions on FDA's AEMS. "VYKAT XR has a compelling risk-benefit profile in the context of a very serious disease. Neurocrine conducted extensive diligence on the safety profile, including adverse event data, during our process to acquire Soleno," said Neurocrine. It added it is "engaged with the FDA, patient advocacy communities and prescribers to continue to assess all available data from postmarketing surveillance as the prescribing population expands." Earlier this year, Neurocrine bought Soleno for $2.9 billion, gaining access to Vykat XR. The joint statement said the reports were concerning and patients and families deserved transparency regarding the drug's safety profile. They stressed, however, the reports do not establish a causal relationship between Vykat XR and the reported outcomes. "The purpose of this new statement is not to discourage the use of VYKAT XR. Rather, it is to encourage informed prescribing, careful patient selection, and close monitoring, particularly for individuals with known risk factors," the statement said. Stat News was the first to report on the matter. Reporting by Puyaan Singh in Bengaluru, additional reporting by Sriparna Roy; Editing by Vijay Kishore Our Standards: The Thomson Reuters Trust Principles., opens new tab |
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2026-08-12 13:05
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2026-08-12 08:30
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Neurocrine Biosciences Announces Publication of KINECT-PRO™ Findings Demonstrating INGREZZA® (valbenazine) Capsules Improved Patient-Reported Quality of Life and Daily Functioning for People Living with Tardive Dyskinesia | FMP Stock News | |
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INGREZZA is the only vesicular monoamine transporter 2 inhibitor with clinical trial data demonstrating improvements in quality of life and functionality in people living with tardive dyskinesia across multiple validated patient-reported outcomes Mean improvements in the patient-reported impacts of tardive dyskinesia and clinician-rated movement severity exceeded established thresholds for clinically meaningful change at Week 24, with improvements observed regardless of underlying psychiatric diagnosis or baseline movement severity Approximately 58% of patients met the threshold for tardive dyskinesia symptomatic remission at Week 24, based on clinician assessment of movement severity Findings reinforce that even patients with mild tardive dyskinesia movements are impacted and can experience meaningful improvements in movement severity, quality of life and functionality with INGREZZA treatment , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced publication of the KINECT-PRO™ Phase 4 open-label study results demonstrating that treatment with once-daily INGREZZA® (valbenazine) capsules resulted in substantial and sustained improvements in patient-reported quality of life and functionality, alongside improvements in clinician-rated tardive dyskinesia (TD) movement severity. Improvements were observed regardless of underlying psychiatric diagnosis or baseline TD movement severity, including among participants with clinician-rated mild TD movements. The manuscript appears in CNS Spectrums.KINECT-PRO is currently the only study to assess the effects of a vesicular monoamine transporter 2 (VMAT2) inhibitor (INGREZZA) on quality of life and functionality using multiple validated patient-reported outcomes (PROs), including the Tardive Dyskinesia Impact Scale (TDIS™). TDIS, developed by Neurocrine Biosciences in partnership with thought leaders in neurology and psychiatry, is a unique, psychometrically validated tool that measures the impact and burden of TD from a patient's perspective. Together with clinician-rated assessments, these findings provide a more comprehensive understanding of how treatment may affect both TD movements and the impact of the disease on patients' daily lives. "The KINECT-PRO clinical study incorporated validated patient-reported measures, including the Tardive Dyskinesia Impact Scale, to better understand the effects of treating tardive dyskinesia with INGREZZA on patient-reported quality of life and functioning," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "These findings add to the extensive body of evidence supporting the meaningful improvements INGREZZA has on movement severity and quality of life and functionality." "Quality of life and day-to-day functioning are important considerations when evaluating the impact of tardive dyskinesia and treatment goals," said Christoph U. Correll, M.D., Professor of Psychiatry, The Zucker Hillside Hospital and primary author of the manuscript. "These findings showed improvements with INGREZZA in both clinician-rated movement severity and patient-reported daily impact and reinforced the potential for meaningful benefit across a broad range of patients regardless of baseline movement severity or underlying psychiatric diagnosis." KINECT-PRO evaluated improvements in outcomes that matter to patients The primary endpoints of KINECT-PRO were changes from baseline to Week 24 in three validated patient-reported measures of quality of life and functionality, including: TDIS: Measures the physical, social and emotional impacts of TD. EuroQoL Visual Analogue Scale (EQ-VAS): Measures patients' self-rated overall health status. The Sheehan Disability Scale (SDS): Measures patient-reported functional impairment in work/school, social life and family/home life. Secondary endpoints evaluated clinician- and patient-reported changes in TD severity using the Abnormal Involuntary Movement Scale (AIMS), the Patient Global Impression of Change (PGI-C) and the Clinical Global Impression of Severity-TD (CGI-TD-S). Fifty-nine patients were enrolled in the KINECT-PRO study and received once-daily INGREZZA (40 mg, 60 mg or 80 mg) for up to 24 weeks. At baseline, approximately 41% of patients (24/59) had clinician-rated mild TD movement severity, while approximately 59% (35/59) had clinician-rated moderate or severe TD movement severity. Approximately 46% of patients (27/59) had schizophrenia or schizoaffective disorder, and approximately 54% (32/59) had major depressive disorder or bipolar disorder. Fifty-two patients completed the Week 24 visit. Patients experienced improvements in quality of life, functionality and movement severity KINECT-PRO participants experienced substantial improvements across the three validated patient-reported measures of quality of life (TDIS, SDS and EQ-VAS), as well as improvements in clinician-reported TD severity. Mean improvements in TD impact (TDIS) and movement severity (AIMS) exceeded established minimal clinically important difference (MCID) thresholds as early as Week 8 and Week 4, respectively, and were sustained to Week 24. Improvements were observed regardless of underlying psychiatric condition or TD movement severity at baseline. Even patients with milder clinician-rated TD movement severity were impacted by TD at baseline and experienced clinically meaningful improvements by Week 24, including a -6.8 mean change from baseline in TDIS and a -5.6 mean change from baseline in AIMS. Approximately 58% of patients (26/45) met the threshold for TD symptomatic remission at Week 24, defined as a movement severity score of 0 ("none") or 1 ("minimal") in each of the seven body regions assessed by AIMS. Safety and tolerability of treatment were consistent with the known profile of INGREZZA, with no new concerns identified. Mean Change from Baseline at Week 24 TDIS† (MCID -4) SDS - Social Life† SDS - Family Life† EQ-VAS‡ AIMS Total Score† (MCID -2) Overall Population (n=45)* -8.0 -2.3 -1.6 +13.1 -6.8 Mild TD Subgroup (n=20) -6.8 -1.8 -1.3 +12.8 -5.6 Moderate/Severe TD Subgroup (n=25) -8.9 -2.8 -1.8 +13.3 -7.8 *52/59 (88%) completed the Week 24 visit; 45 were included for efficacy analyses. †A decrease in score indicated improvement. ‡An increase in score indicated improvement. About the KINECT-PRO™ Phase 4 Study The KINECT-PRO™ Phase 4, open-label study was designed to evaluate patient-reported outcomes on the use of INGREZZA® (valbenazine) capsules in a tardive dyskinesia (TD) patient population reflective of real-world clinical practice. Participants had at least mild TD, were aware of and experiencing at least mild distress from their abnormal, involuntary movements and had a clinical diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression. The KINECT-PRO study included a four-week screening period, a 24-week treatment period during which participants received 40 mg of INGREZZA once-daily for the first four weeks, followed by flexible dosing of 40 mg, 60 mg or 80 mg once-daily based on individual treatment needs and a two-week safety follow-up period. Baseline socio-demographic and clinical characteristics of the participants were broadly similar to those of the KINECT® 3 and KINECT® 4 studies. KINECT-PRO is the first and only study to specifically evaluate and demonstrate patient-reported improvement with vesicular monoamine transporter 2 inhibitor treatment on TD using multiple clinically validated scales, including the Tardive Dyskinesia Impact Scale (TDIS™). The TDIS is the only patient-reported outcome instrument designed for and psychometrically validated in tardive dyskinesia patients that measures the physical, social and emotional impact of the involuntary movements of the condition. About the Tardive Dyskinesia Impact Scale The Tardive Dyskinesia Impact Scale (TDIS™) is the only patient-reported outcome instrument designed for and validated in tardive dyskinesia patients that measures the physical, social and emotional impact of the involuntary movements of the condition. It was developed by Neurocrine Biosciences in partnership with thought leaders in neurology and psychiatry from qualitative studies and Phase 3 trials of INGREZZA for the treatment of TD (KINECT® 3 and KINECT® 4) as a comprehensive measure of impact and burden of TD from a patient's perspective. The TDIS consists of 11 questions evaluating physical and socio-emotional impact. Six scales are assessed: mouth/throat, dexterity, mobility, pain, social and emotional. The TDIS allows people with TD to rate how their symptoms affect daily activities and how their uncontrollable movements make them feel. The questionnaire captures relevant information about the impact of TD to provide a more holistic assessment of the condition. Validation of this scale was published in the Journal of Patient-Reported Outcomes. About the EQ Visual Analogue Scale and the Sheehan Disability Scale The EQ Visual Analogue Scale (EQ-VAS) is the second component of the 5-level EQ 5D (EQ-5D-5L). The EQ-VAS is a visual scale ranging from 0 "the worst health you can imagine" to 100 "the best health you can imagine" that assesses a patient's self-rated health, with higher scores indicating better health status. The Sheehan Disability Scale (SDS) is a five-item, patient-reported outcome measure which includes social, family and occupational life domains. Three items assess impairment in terms of work/school, social life and family life/home responsibilities and are scored independently (0 [not impaired] to 10 [extremely impaired]) or combined for a total score (0 to 30). Two items assess number of days lost or underproductive. A decrease in score indicates improvement. About Tardive Dyskinesia Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrolled, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be mild to severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S. About INGREZZA® (valbenazine) Capsules and INGREZZA® SPRINKLE (valbenazine) Capsules INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). Only INGREZZA offers a therapeutic dose from day one with no required titration. INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements. INGREZZA is studied across the widest range of patients. It is always one capsule, once daily and can be taken together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules. Important Information Approved Uses INGREZZA® (valbenazine) capsules or INGREZZA® SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with: movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions. It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children. IMPORTANT SAFETY INFORMATION INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself. Do not take INGREZZA or INGREZZA SPRINKLE if you: are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE. INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including: Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema, can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema. Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE. Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint. Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat. Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls. Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia are sleepiness and tiredness. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep. These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules. Please see full Prescribing Information, including Boxed Warning, and Medication Guide. About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, KINECT and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc. KINECT-PRO and TDIS are trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA, the interpretation and potential relevance of the data described in this press release, including statements regarding clinically meaningful improvements in patient-reported quality of life and functional capacity and clinician-rated movement severity among patients with tardive dyskinesia, and the value INGREZZA may bring to patients. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of INGREZZA; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA; whether INGREZZA receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for INGREZZA or other product candidates may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding INGREZZA; risks that post-approval INGREZZA commitments or requirements may be delayed; risks that INGREZZA may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2026 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-VBZ-US-0106 08/2026 SOURCE Neurocrine Biosciences, Inc. |
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Neurocrine Biosciences, Inc. $NBIX Shares Purchased by Cetera Investment Advisers | FMP Stock News | |
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Posted by Defense World Staff on Aug 8th, 2026Cetera Investment Advisers increased its holdings in shares of Neurocrine Biosciences, Inc. (NASDAQ:NBIX – Free Report) by 50.1% in the 1st quarter, according to the company in its most recent Form 13F filing with the Securities and Exchange Commission (SEC). The fund owned 20,245 shares of the company’s stock after purchasing an additional 6,756 shares during the period. Cetera Investment Advisers’ holdings in Neurocrine Biosciences were worth $2,667,000 as of its most recent filing with the Securities and Exchange Commission (SEC). Other hedge funds also recently added to or reduced their stakes in the company. Aureus Asset Management LLC acquired a new position in shares of Neurocrine Biosciences in the 1st quarter valued at about $1,253,000. First Trust Advisors LP lifted its holdings in Neurocrine Biosciences by 97.0% in the first quarter. First Trust Advisors LP now owns 959,217 shares of the company’s stock valued at $126,367,000 after acquiring an additional 472,408 shares during the period. Westpac Banking Corp lifted its holdings in Neurocrine Biosciences by 6.0% in the first quarter. Westpac Banking Corp now owns 1,615 shares of the company’s stock valued at $213,000 after acquiring an additional 91 shares during the period. ABN Amro Investment Solutions boosted its position in Neurocrine Biosciences by 12.3% in the 1st quarter. ABN Amro Investment Solutions now owns 3,040 shares of the company’s stock worth $400,000 after purchasing an additional 334 shares in the last quarter. Finally, PNC Financial Services Group Inc. boosted its position in Neurocrine Biosciences by 12.2% in the 1st quarter. PNC Financial Services Group Inc. now owns 5,630 shares of the company’s stock worth $742,000 after purchasing an additional 614 shares in the last quarter. 92.59% of the stock is owned by hedge funds and other institutional investors. Neurocrine Biosciences Stock Up 2.2% Shares of NASDAQ NBIX opened at $163.41 on Friday. The firm has a 50-day simple moving average of $168.49 and a 200-day simple moving average of $147.45. The stock has a market capitalization of $16.61 billion, a price-to-earnings ratio of 23.96, a price-to-earnings-growth ratio of 0.56 and a beta of 0.39. Neurocrine Biosciences, Inc. has a 52 week low of $122.14 and a 52 week high of $186.12. Analyst Ratings Changes A number of research analysts have weighed in on the stock. Canaccord Genuity Group lifted their price objective on shares of Neurocrine Biosciences from $200.00 to $210.00 and gave the company a “buy” rating in a report on Monday, August 3rd. Guggenheim raised their target price on Neurocrine Biosciences from $200.00 to $222.00 and gave the company a “buy” rating in a research report on Friday, July 31st. Piper Sandler lifted their price target on Neurocrine Biosciences from $207.00 to $210.00 and gave the company an “overweight” rating in a research note on Friday, July 31st. Zacks Research cut Neurocrine Biosciences from a “strong-buy” rating to a “hold” rating in a report on Tuesday. Finally, Stifel Nicolaus increased their price target on Neurocrine Biosciences from $188.00 to $215.00 and gave the stock a “buy” rating in a research report on Friday, July 31st. One equities research analyst has rated the stock with a Strong Buy rating, nineteen have issued a Buy rating and four have assigned a Hold rating to the stock. According to data from MarketBeat.com, Neurocrine Biosciences has a consensus rating of “Moderate Buy” and a consensus target price of $201.50. View Our Latest Stock Analysis on NBIX Insider Activity In other news, insider Darin Lippoldt sold 10,000 shares of Neurocrine Biosciences stock in a transaction that occurred on Thursday, July 9th. The shares were sold at an average price of $179.60, for a total transaction of $1,796,000.00. Following the sale, the insider owned 54,729 shares of the company’s stock, valued at approximately $9,829,328.40. The trade was a 15.45% decrease in their position. The transaction was disclosed in a filing with the Securities & Exchange Commission, which can be accessed through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, Director Stephen A. Sherwin sold 25,000 shares of the company’s stock in a transaction that occurred on Friday, June 5th. The shares were sold at an average price of $165.32, for a total value of $4,133,000.00. Following the completion of the transaction, the director owned 15,860 shares in the company, valued at $2,621,975.20. This represents a 61.18% decrease in their ownership of the stock. Additional details regarding this sale are available in the official SEC disclosure. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders have sold 395,422 shares of company stock worth $62,448,693 over the last quarter. 4.60% of the stock is currently owned by corporate insiders. Neurocrine Biosciences Profile (Free Report) Neurocrine Biosciences (NASDAQ: NBIX) is a biopharmaceutical company based in San Diego, California, focused on developing treatments for neurological, endocrine and neuropsychiatric disorders. Since its founding in 1992, the company has pursued a research‐driven strategy aimed at addressing unmet medical needs in movement disorders, reproductive health and central nervous system conditions. Neurocrine’s operations encompass drug discovery, clinical development and commercialization activities. The company’s lead marketed product, Ingrezza™ (valbenazine), is indicated for the treatment of tardive dyskinesia, a movement disorder associated with long-term antipsychotic use. See Also Five stocks we like better than Neurocrine Biosciences Datadog’s Drop Says More About Expectations Than Earnings D-Wave’s Quantum Breakthrough Couldn’t Save QBTS From a Sell-Off Cloudflare’s Beat-and-Raise Quarter Puts Its AI Edge Story in Focus Solventum Nears Inflection Point As It Begins to Unlock Value Want to see what other hedge funds are holding NBIX? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Neurocrine Biosciences, Inc. (NASDAQ:NBIX – Free Report). Receive News & Ratings for Neurocrine Biosciences Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Neurocrine Biosciences and related companies with MarketBeat.com's FREE daily email newsletter. « PREVIOUS HEADLINEDaily Journal Corp. (S.C.) $DJCO Shares Sold by Dimensional Fund Advisors LP NEXT HEADLINE »Dimensional Fund Advisors LP Acquires 206,716 Shares of ARKO Corp. $ARKO |
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2026-08-07 12:45
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2026-08-07 08:30
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Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating NBIP-'1968, a GLP-1/GIP/Glucagon Receptor Triple Agonist | FMP Stock News | |
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Initiation of study marks an important milestone in advancing Neurocrine's obesity portfolio and investigational metabolic disease pipeline , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of a Phase 1 first-in-human clinical study evaluating the safety and tolerability of NBIP-'1968, an investigational GLP-1/GIP/glucagon receptor triple agonist being developed as a therapy for obesity."Obesity is a complex chronic disease driven by multiple biological pathways, underscoring the need for additional treatment options," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "NBIP-'1968 is designed to engage three complementary metabolic mechanisms, reflecting our commitment to exploring multiple scientific approaches to obesity." The Phase 1 study initially will evaluate the safety and tolerability of single ascending doses of NBIP-'1968 in adult participants across a range of body mass index categories, including overweight and obese. NBIP-'1968 is an internally discovered, investigational long-acting triple agonist designed for once-weekly subcutaneous administration. It targets the receptors for glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) and glucagon to influence metabolic pathways involved in appetite regulation, energy balance and glycemic control. NBIP-'1968 was designed with balanced glucagon receptor activity to optimize the potential metabolic benefits of glucagon receptor activation while supporting tolerability. Neurocrine is developing NBIP-'1968 as part of a broader obesity portfolio that includes NBIP-'2118, an investigational corticotropin-releasing factor type 2 receptor agonist currently in Phase 1 development. NBIP-'1968 is intended for use in a fixed-dose combination with NBIP-'2118. The company's obesity research also includes earlier-stage programs designed to explore complementary mechanisms and extended dosing intervals. "Advancing NBIP-'1968 into the clinic marks another important step in building our obesity portfolio," said Jude Onyia, Ph.D., Chief Scientific Officer, Neurocrine Biosciences. "Our strategy is to explore complementary and differentiated mechanisms that may improve weight loss, preserve lean mass and ultimately address the diverse needs of people living with obesity." About Obesity Obesity is a chronic disease characterized by excess body fat and is associated with serious health conditions, including type 2 diabetes, cardiovascular disease, obstructive sleep apnea, metabolic dysfunction-associated steatohepatitis/fatty liver disease, certain cancers and osteoarthritis. It is driven by complex biological, environmental, and genetic factors – not simply lifestyle or willpower. Obesity has reached epidemic levels worldwide, affecting a significant proportion of adults and placing a substantial burden on public health systems. Despite recent advances in treatment, there remains a need for additional therapies that support safe, effective and sustainable long-term weight management. Current therapies can have challenges with respect to gastrointestinal tolerability, dose titration, and muscle loss. About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) NEUROCRINE, the NEUROCRINE BIOSCIENCES logo and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the efficacy and therapeutic potential of NBIP-'2118, NBIP-'1968 and other preclinical programs for obesity. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that regulatory submissions for our product candidates may not occur or be submitted in a timely manner; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing and commercialization activities for our products and product candidates and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with U.S. federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse impact on our revenues or potential revenue; risks associated with potential generic entrants for our products; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2026 Neurocrine Biosciences. Inc. All Rights Reserved. SOURCE Neurocrine Biosciences, Inc. |
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2026-08-03 14:55
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2026-08-03 06:37
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Glenmede Trust Co. NA Has $10.35 Million Stock Position in Neurocrine Biosciences, Inc. $NBIX | FMP Stock News | |
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Posted by Defense World Staff on Aug 3rd, 2026Glenmede Trust Co. NA reduced its holdings in Neurocrine Biosciences, Inc. (NASDAQ:NBIX – Free Report) by 3.8% in the 1st quarter, according to the company in its most recent 13F filing with the Securities and Exchange Commission. The institutional investor owned 78,577 shares of the company’s stock after selling 3,124 shares during the period. Glenmede Trust Co. NA owned about 0.08% of Neurocrine Biosciences worth $10,352,000 at the end of the most recent reporting period. A number of other institutional investors have also recently bought and sold shares of the business. AQR Capital Management LLC grew its stake in Neurocrine Biosciences by 18.0% during the 4th quarter. AQR Capital Management LLC now owns 3,271,706 shares of the company’s stock valued at $462,652,000 after acquiring an additional 498,058 shares in the last quarter. Renaissance Technologies LLC lifted its position in shares of Neurocrine Biosciences by 8.0% in the first quarter. Renaissance Technologies LLC now owns 2,418,897 shares of the company’s stock worth $318,665,000 after purchasing an additional 180,100 shares in the last quarter. Geode Capital Management LLC boosted its holdings in shares of Neurocrine Biosciences by 1.7% during the fourth quarter. Geode Capital Management LLC now owns 2,059,282 shares of the company’s stock worth $291,342,000 after purchasing an additional 34,457 shares during the period. Los Angeles Capital Management LLC boosted its holdings in shares of Neurocrine Biosciences by 7.4% during the fourth quarter. Los Angeles Capital Management LLC now owns 1,291,278 shares of the company’s stock worth $178,248,000 after purchasing an additional 88,522 shares during the period. Finally, Northern Trust Corp grew its position in Neurocrine Biosciences by 31.9% during the fourth quarter. Northern Trust Corp now owns 1,221,184 shares of the company’s stock valued at $173,201,000 after purchasing an additional 295,470 shares in the last quarter. 92.59% of the stock is currently owned by institutional investors and hedge funds. Neurocrine Biosciences Stock Performance Shares of NASDAQ NBIX opened at $166.80 on Monday. The business has a 50 day simple moving average of $167.81 and a 200 day simple moving average of $146.50. Neurocrine Biosciences, Inc. has a 52 week low of $122.14 and a 52 week high of $186.12. The stock has a market cap of $16.77 billion, a price-to-earnings ratio of 24.46, a PEG ratio of 0.70 and a beta of 0.39. Wall Street Analyst Weigh In Several research analysts have weighed in on NBIX shares. Guggenheim upped their price objective on shares of Neurocrine Biosciences from $200.00 to $222.00 and gave the company a “buy” rating in a research note on Friday. Wall Street Zen lowered shares of Neurocrine Biosciences from a “strong-buy” rating to a “buy” rating in a research note on Saturday. Stifel Nicolaus boosted their price target on shares of Neurocrine Biosciences from $188.00 to $215.00 and gave the company a “buy” rating in a report on Friday. Piper Sandler upped their price target on shares of Neurocrine Biosciences from $207.00 to $210.00 and gave the stock an “overweight” rating in a research note on Friday. Finally, BMO Capital Markets upped their price target on shares of Neurocrine Biosciences from $144.00 to $170.00 and gave the stock a “market perform” rating in a research note on Monday, July 13th. Two research analysts have rated the stock with a Strong Buy rating, nineteen have issued a Buy rating and three have given a Hold rating to the stock. Based on data from MarketBeat, the stock has an average rating of “Moderate Buy” and a consensus price target of $199.64. View Our Latest Analysis on NBIX Insider Buying and Selling at Neurocrine Biosciences In other Neurocrine Biosciences news, insider Ingrid Delaet sold 4,367 shares of Neurocrine Biosciences stock in a transaction that occurred on Friday, July 10th. The shares were sold at an average price of $181.02, for a total value of $790,514.34. Following the completion of the sale, the insider directly owned 16,225 shares in the company, valued at $2,937,049.50. The trade was a 21.21% decrease in their ownership of the stock. The transaction was disclosed in a legal filing with the Securities & Exchange Commission, which is available through the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, Director Stephen A. Sherwin sold 25,000 shares of the business’s stock in a transaction that occurred on Friday, June 5th. The stock was sold at an average price of $165.32, for a total transaction of $4,133,000.00. Following the completion of the sale, the director directly owned 15,860 shares of the company’s stock, valued at $2,621,975.20. This represents a 61.18% decrease in their ownership of the stock. Additional details regarding this sale are available in the official SEC disclosure. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders have sold 395,422 shares of company stock valued at $62,448,693 over the last three months. 4.60% of the stock is owned by insiders. Neurocrine Biosciences News Summary Here are the key news stories impacting Neurocrine Biosciences this week: Positive Sentiment: Strong Q2 performance: Second-quarter revenue rose 39% year over year to $959 million, exceeding the approximately $891 million analyst estimate. Adjusted earnings were $2.85 per share versus the $2.26 consensus, while net income increased to $144.4 million. Neurocrine Biosciences Reports Second-Quarter 2026 Financial Results Positive Sentiment: Product and pipeline growth: INGREZZA sales increased 15% to $716 million, while CRENESSITY generated $184 million and newly acquired VYKAT XR contributed $54 million. Neurocrine also raised its 2026 INGREZZA sales guidance to $2.825 billion-$2.875 billion, supporting the company’s commercial outlook and Soleno Therapeutics acquisition. NBIX Q2 Earnings Call Highlights Positive Sentiment: Analyst support strengthened: TD Cowen, Guggenheim, Stifel, Cantor Fitzgerald, Piper Sandler, Needham, RBC and Morgan Stanley all raised their price targets, with targets ranging from $196 to $222. William Blair also reiterated a Buy rating, citing strong execution and substantial pipeline potential. Analyst Price Target Updates Neutral Sentiment: Investor expectations remain elevated: Although NBIX beat quarterly estimates, the market appears to have wanted a larger revenue upside surprise or more aggressive full-year guidance. The reaction suggests investors may be reassessing how much near-term upside is already reflected in the shares. Negative Sentiment: Insider selling adds a cautionary signal: Director Leslie Norwalk sold 1,250 shares for about $228,000 under a pre-arranged Rule 10b5-1 plan. Broader data also show numerous insider sales and no open-market purchases over the past six months, though such transactions may be planned and do not necessarily indicate deteriorating fundamentals. SEC Insider Trading Filing About Neurocrine Biosciences (Free Report) Neurocrine Biosciences (NASDAQ: NBIX) is a biopharmaceutical company based in San Diego, California, focused on developing treatments for neurological, endocrine and neuropsychiatric disorders. Since its founding in 1992, the company has pursued a research‐driven strategy aimed at addressing unmet medical needs in movement disorders, reproductive health and central nervous system conditions. Neurocrine’s operations encompass drug discovery, clinical development and commercialization activities. The company’s lead marketed product, Ingrezza™ (valbenazine), is indicated for the treatment of tardive dyskinesia, a movement disorder associated with long-term antipsychotic use. Read More Five stocks we like better than Neurocrine Biosciences 3 Fixed-Income ETFs Show Why Yield Is Only Part of the Income Story AbbVie Quietly Solved Its Biggest Problem—Now What? Rio Tinto’s Results Make the Case for Looking Beyond Tech in the AI Trade Strategy’s Structural Strength: Hidden in a $8 Billion Illusion Want to see what other hedge funds are holding NBIX? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Neurocrine Biosciences, Inc. (NASDAQ:NBIX – Free Report). Receive News & Ratings for Neurocrine Biosciences Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Neurocrine Biosciences and related companies with MarketBeat.com's FREE daily email newsletter. « PREVIOUS HEADLINEMicrosoft Corporation $MSFT Stake Decreased by Catalyst Capital Advisors LLC |
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NBIX Q2 Earnings Call Highlights: Portfolio Expansion Drives Growth | FMP Stock News | |
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Key Takeaways NBIX reported $959M in revenues, driven by commercial execution and portfolio expansion.INGREZZA sales rose 15% y/y as prescriptions and market growth continued.NBIX expects Phase III readouts in 2027 for osavampator and direclidine programs. Neurocrine Biosciences, Inc. (NBIX - Free Report) highlighted the continued expansion of its commercial portfolio during its second-quarter 2026 earnings call, with management emphasizing growth from INGREZZA, CRENESSITY and the newly acquired VYKAT XR. The company also outlined upcoming clinical catalysts and its strategy to diversify beyond its established franchises.The company reported non-GAAP earnings of $2.85 per share, beating the Zacks Consensus Estimate of $2.26. Revenues were $959 million, surpassing the estimate of $901.5 million. Management focused on commercial execution, pipeline advancement and disciplined business development following the Soleno Therapeutics acquisition. NBIX Builds Broader Commercial FoundationNeurocrine said that its second-quarter results reflected progress toward becoming a diversified biotechnology company rather than a single-product business. CEO Kyle Gano noted that the company’s commercial portfolio generated more than $950 million in quarterly net product sales. INGREZZA remained the largest contributor, with second-quarter net sales of $716 million, up 15% year over year. Management attributed the performance to record patient additions, prescription growth, and sustained demand in tardive dyskinesia and Huntington’s disease chorea. Chief commercial officer Eric Benevich said that INGREZZA continued to benefit from market expansion, with the VMAT2 category growing and the company maintaining its position as the most prescribed VMAT2 inhibitor. CRENESSITY Maintains Strong Launch MomentumCRENESSITY continued to gain adoption in classic congenital adrenal hyperplasia (CAH). The therapy generated second-quarter sales of $184 million compared with $53 million in the prior-year period, supported by patient demand and expanding physician adoption. Benevich said that the launch trajectory remained consistent, with steady patient additions, favorable reimbursement and increasing prescriber engagement. Approximately 15% of the estimated diagnosed patient population has now been prescribed CRENESSITY. During Q&A, a TD Cowen analyst asked whether the quarter benefited from unusual factors. Benevich responded that results reflected the ongoing launch pattern rather than a one-time boost, with continued adoption across pediatric endocrinologists, adult endocrinologists and CAH Centers of Excellence. Neurocrine Integrates VYKAT XR AcquisitionThe acquisition of Soleno Therapeutics added VYKAT XR to Neurocrine’s portfolio, expanding its rare disease and endocrinology presence. The transaction closed in May 2026 for $2.9 billion. VYKAT XR generated $54 million in recognized second-quarter sales following the acquisition close, while pro-forma full-quarter sales were $94 million. Management said that integration efforts are progressing and expects sequential quarterly growth exiting 2026. During Q&A, a BofA Securities analyst questioned the near-term launch trajectory. Benevich said that the company remains confident in VYKAT XR’s long-term potential, with priorities centered on identifying patients, educating providers and improving treatment adoption in Prader-Willi syndrome. NBIX Advances Pipeline CatalystsManagement highlighted several late-stage programs expected to provide growth opportunities. Chief medical officer Sanjay Keswani said that the company remains on track for Phase III data readouts for osavampator in major depressive disorder and direclidine in schizophrenia in 2027. The company is also advancing its muscarinic franchise, with multiple programs targeting neurological and psychiatric conditions. Chief business officer Samir Siddhanti said that the pipeline includes four muscarinic programs spanning schizophrenia, bipolar mania and Alzheimer’s disease-related indications. Management also discussed its obesity research efforts, noting that its CRF2 agonist program is progressing through Phase I development with future studies focused on weight loss and lean mass preservation. Neurocrine Expands Investment CapacityNBIX increased investment across research and commercial infrastructure while integrating VYKAT XR. Second-quarter GAAP research and development expenses rose to $327 million from $244 million a year earlier, while GAAP selling, general and administrative expenses increased to $440 million from $286 million. The company raised its 2026 INGREZZA sales guidance to $2.83-$2.88 billion from the previous $2.7-$2.8 billion. Management also updated the expense guidance to reflect expanded commercial activities and acquisition-related costs. Chief financial officer Matthew Abernethy said that the company ended the quarter with approximately $500 million in cash and no debt after completing the Soleno acquisition. NBIX Maintains Long-Term Growth FocusNeurocrine emphasized a strategy built around commercial execution, pipeline development and selective business development. Management said that the company’s expanded portfolio provides greater flexibility to invest through innovation cycles. The company continues to focus on advancing first-in-class and potentially best-in-class medicines across neuroscience, psychiatry, endocrinology and immunology. Upcoming clinical milestones remain central to management’s long-term growth plans. Zacks Rank & Style ScoresNBIX carries a Zacks Rank #2 (Buy) at present. The Zacks Rank reflects earnings estimate revision trends and can change as analysts update their expectations following new company developments and the quarterly results. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. The stock has a Value Score of B, a Growth Score of A, a Momentum Score of F and a VGM Score of B. Zacks Style Scores evaluate value, growth and momentum characteristics, with stronger grades representing more favorable relative attributes. |
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Neurocrine Biosciences, Inc. (NBIX) Q2 2026 Earnings Call Transcript | FMP Stock News | |
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Neurocrine Biosciences, Inc. (NBIX) Q2 2026 Earnings Call Transcript |
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2026-07-30 23:20
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2026-07-30 18:16
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Neurocrine Biosciences (NBIX) Surpasses Q2 Earnings and Revenue Estimates | FMP Stock News | |
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Neurocrine Biosciences (NBIX - Free Report) came out with quarterly earnings of $2.85 per share, beating the Zacks Consensus Estimate of $2.26 per share. This compares to earnings of $1.06 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +26.11%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $1.68 per share when it actually produced earnings of $1.94, delivering a surprise of +15.48%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Neurocrine, which belongs to the Zacks Medical - Drugs industry, posted revenues of $959 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 6.37%. This compares to year-ago revenues of $687.5 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Neurocrine shares have added about 27.5% since the beginning of the year versus the S&P 500's gain of 6.9%. What's Next for Neurocrine?While Neurocrine has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Neurocrine was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $2.47 on $1.01 billion in revenues for the coming quarter and $9.09 on $3.77 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the top 38% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Theravance Biopharma (TBPH - Free Report) , another stock in the same industry, has yet to report results for the quarter ended June 2026. This biopharmaceutical company is expected to post quarterly earnings of $0.19 per share in its upcoming report, which represents a year-over-year change of +337.5%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Theravance Biopharma's revenues are expected to be $19.79 million, down 24.4% from the year-ago quarter. |
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Neurocrine (NBIX) Reports Q2 Earnings: What Key Metrics Have to Say | FMP Stock News | |
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Neurocrine Biosciences (NBIX - Free Report) reported $959 million in revenue for the quarter ended June 2026, representing a year-over-year increase of 39.5%. EPS of $2.85 for the same period compares to $1.06 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $901.54 million, representing a surprise of +6.37%. The company delivered an EPS surprise of +26.11%, with the consensus EPS estimate being $2.26. While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance. Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance. Here is how Neurocrine performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Revenues- Product sales, net: $954.3 million versus $881.08 million estimated by eight analysts on average. Compared to the year-ago quarter, this number represents a +39.9% change.Revenues- Product sales, net- CRENESSITY: $184 million compared to the $170.78 million average estimate based on seven analysts.Revenues- Collaboration revenue: $4.7 million compared to the $6.02 million average estimate based on seven analysts. The reported number represents a change of -14.6% year over year.Revenues- Product sales, net- INGREZZA: $716 million compared to the $628.59 million average estimate based on seven analysts. The reported number represents a change of +14.7% year over year.View all Key Company Metrics for Neurocrine here>>> Shares of Neurocrine have returned +7.8% over the past month versus the Zacks S&P 500 composite's -1.5% change. The stock currently has a Zacks Rank #2 (Buy), indicating that it could outperform the broader market in the near term. |
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Neurocrine Biosciences Reports Second-Quarter 2026 Financial Results | FMP Stock News | |
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Total Second-Quarter 2026 Revenue Grew 39% Year-Over-Year to $959 MillionINGREZZA® (valbenazine) 2026 Net Sales Guidance Raised to $2.825 to $2.875 Billion Acquisition of Soleno Therapeutics Completed in May 2026 , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the second quarter ended June 30, 2026. "Our second quarter performance demonstrates the power of a strategy designed to compound over time," said Kyle W. Gano, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "As our commercial portfolio of first-in-class medicines continues to grow, so does our capacity to reinvest in innovation, advance a differentiated late-stage pipeline and pursue strategic opportunities that strengthen the company for the long term. With multiple important clinical milestones in 2027, including Phase 3 readouts for osavampator in major depressive disorder and direclidine in schizophrenia, we are building an enduring company poised to deliver meaningful value for patients and shareholders for years to come." Total Revenue Highlights Three Months Ended June 30, (unaudited, in millions, except per share data) 2026 2025 YoY Growth Revenues: INGREZZA Net Product Sales $ 716 $ 624 15 % CRENESSITY® (crinecerfont) Net Product Sales 184 53 247 % VYKAT® (diazoxide choline) XR Net Product Sales* 54 — NM Other Revenues 5 11 NM Total Revenues $ 959 $ 688 39 % * Net product sales for VYKAT XR are included from the closing of the Soleno Therapeutics acquisition on May 18th Total revenues for the second quarter 2026 were $959 million, compared with $688 million in the prior-year period representing 39% year-over-year growth. Unaudited pro-forma total revenues were $998 million for the second quarter 2026 when including full quarter VYKAT XR net product sales. INGREZZA second-quarter 2026 net product sales were $716 million, representing 15% growth year-over-year. Results reflected double-digit prescription volume growth in TRx and record NRx driven by strong patient demand. INGREZZA full year 2026 guidance was increased from a range of $2.7 billion to $2.8 billion up to $2.825 billion to $2.875 billion. CRENESSITY second-quarter 2026 net product sales were $184 million, driven by strong patient demand with approximately 80% reimbursement for dispensed prescriptions in the second quarter 2026. VYKAT XR second-quarter 2026 net product sales were $54 million from May 18, 2026, the closing date of the Soleno acquisition. Unaudited pro-forma full quarter net product sales were $94 million. Recent Clinical and Corporate Developments In May 2026, acquired Soleno Therapeutics for $53.00 per share in cash, representing a total transaction equity value of $2.9 billion. The addition of VYKAT XR, a first-in-class therapy to treat hyperphagia in Prader-Willi syndrome (PWS), expands Neurocrine's portfolio of innovative medicines and strengthens its leadership position in endocrinology and rare disease. In May 2026, the Company entered into a $1.0 billion senior secured revolving credit facility to provide an additional source of liquidity for general corporate purposes. As of June 30, 2026, available borrowing capacity was $1.0 billion. Announced new two-year data from the Phase 3 CAHtalyst® Pediatric study showing positive growth outcomes in children and adolescents with classic congenital adrenal hyperplasia treated with CRENESSITY. Announced new two-year data from the Phase 3 CAHtalyst® Adult study demonstrating improved cardiometabolic outcomes alongside sustained glucocorticoid dose reduction through up to two years of treatment with CRENESSITY for classic congenital adrenal hyperplasia. Announced publication of expert recommendations for glucocorticoid dose reduction after initiating CRENESSITY for the treatment of classic congenital adrenal hyperplasia. Presented new VYKAT XR data demonstrating meaningful and durable improvements in hyperphagia and behavioral symptoms in Prader-Willi syndrome following randomized withdrawal period. Announced new post-hoc data from the KINECT® 4 clinical trial demonstrating that adults with tardive dyskinesia treated with INGREZZA capsules experienced clinically meaningful and robust improvements in involuntary movement severity, including those who did not meet the stringent symptomatic remission threshold. Initiated Phase 2 clinical study to assess the safety and tolerability of crinecerfont in children aged 3 months to under 4 years with classic congenital adrenal hyperplasia. Promoted Samir Siddhanti to the executive management team as Chief Business Officer where he will lead the Company's business development, corporate strategy, and R&D portfolio management functions helping guide Neurocrine's continued evolution into a leading, global biotechnology company. Second-Quarter 2026 Financial Results Three Months Ended June 30, (unaudited, in millions, except per share data) 2026 2025 Total Revenues $ 959 $ 688 GAAP Cost of Revenues $ 23 $ 10 Non-GAAP Cost of Revenues $ 18 $ 10 GAAP Research and Development (R&D) $ 327 $ 244 Non-GAAP R&D $ 276 $ 223 GAAP Selling, General, and Administrative (SG&A) $ 440 $ 286 Non-GAAP SG&A $ 305 $ 255 GAAP Net Income $ 144 $ 108 GAAP Earnings Per Share – Diluted $ 1.39 $ 1.06 Non-GAAP Net Income $ 297 $ 166 Non-GAAP Earnings Per Share – Diluted $ 2.85 $ 1.65 (unaudited, in millions) June 30, 2026 December 31, 2025 Total Cash, Cash Equivalents, and Marketable Securities $ 482 $ 2,543 Second-quarter 2026 GAAP net income and earnings per share were $144 million and $1.39, respectively, compared with $108 million and $1.06, respectively, for second-quarter 2025. Second-quarter 2026 Non-GAAP net income and earnings per share were $297 million and $2.85, respectively, compared with $166 million and $1.65, respectively, for second-quarter 2025. A reconciliation of GAAP to Non-GAAP financial results can be found in Table 3 at the end of this press release. Second-quarter 2026 GAAP and Non-GAAP net income compared with second-quarter 2025 were primarily driven by: Higher net product sales of $272 million. For the second quarter 2026, GAAP operating expenses included certain expenses associated with the acquisition of Soleno Therapeutics, Inc., which closed in May 2026, and are excluded from Non-GAAP operating expenses. Increased R&D expense in support of an expanded and advancing pre-clinical and clinical portfolio included investments in the osavampator Phase 3 program in major depressive disorder (MDD) and the muscarinic franchise, including the direclidine Phase 3 program as a potential treatment for adults with schizophrenia. Development milestone expense included in R&D was $0.3 million and $15 million for the second quarter 2026 and 2025. Increased SG&A expense primarily reflected continued investment in our commercial organization, included the expansion of our INGREZZA and CRENESSITY sales teams in the first quarter of 2026 and partial quarter of expense for support of VYKAT XR. At June 30, 2026, the Company had cash, cash equivalents, and marketable securities totaling approximately $482 million. Full Year 2026 Financial Guidance (dollars in millions) Prior Updated INGREZZA Net Product Sales 1 $2,700 - $2,800 $2,825 - $2,875 GAAP R&D 2 $1,200 - $1,250 $1,275 - $1,325 Non-GAAP R&D 2, 3 $1,110 - $1,160 $1,140 - $1,190 IPR&D 4 $20 $23 GAAP SG&A 5 $1,375 - $1,400 $1,575 - $1,600 Non-GAAP SG&A 3, 5 $1,240 - $1,265 $1,325 - $1,350 GAAP Amortization of Acquired Intangible Assets 6 Not applicable $85 - $90 INGREZZA sales guidance reflects expected net product sales of INGREZZA in tardive dyskinesia and chorea associated with Huntington's disease. R&D guidance reflects the continued advancement of the Company's pre-clinical and clinical portfolio including the Phase 3 programs for osavampator in MDD and direclidine in schizophrenia, and includes approximately $25 million of expense for development milestones related to our in-licensed product candidates. Development milestones are included in R&D guidance once achieved or deemed probable to achieve. Non-GAAP guidance has been adjusted to exclude estimated non-cash stock-based compensation expense of approximately $115 million in R&D and $170 million in SG&A, including approximately $58 million related to the acceleration of vesting of equity awards for Soleno employees which vested in full upon the closing of the transaction, and acquisition, integration and divestiture-related expenses of approximately $95 million. Non-cash stock-based compensation expense for performance-based equity awards is included in guidance once the predefined performance-based criteria for vesting is achieved or deemed probable to achieve. IPR&D guidance represents completed collaboration and licensing arrangements. SG&A guidance reflects expense for ongoing commercial initiatives, including the recent expansion of our sales teams in Q1 2026, supporting INGREZZA growth and the launch of CRENESSITY and VYKAT XR. In connection with the acquisition of Soleno, the Company recorded approximately $2.2 billion of intellectual property related to VYKAT XR to the balance sheet, which will be amortized over an expected life of 16 years. Conference Call and Webcast Today at 4:30 PM Eastern Time Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 800-347-6865 (US) or 203-518-9757 (International) using the conference ID: NBIX. The webcast and accompanying slides can also be accessed at approximately 4:30 p.m. Eastern Time on Neurocrine Biosciences' website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month. About Neurocrine Biosciences Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, YOU DESERVE BRAVE SCIENCE, INGREZZA, and CRENESSITY are registered trademarks of Neurocrine Biosciences, Inc. VYKAT is a registered trademark of Soleno Therapeutics, Inc. Non-GAAP Financial Measures In addition to the financial results and financial guidance that are provided in accordance with accounting principles generally accepted in the United States (GAAP), this press release also contains the following Non-GAAP financial measures: Non-GAAP cost of revenues, Non-GAAP R&D expense, Non-GAAP SG&A expense, Non-GAAP other income (expense), net, Non-GAAP net income and earnings per share. When preparing the Non-GAAP financial results and guidance, the Company excludes certain GAAP items that management does not consider to be normal, including recurring cash operating expenses that might not meet the definition of unusual or non-recurring items. In particular, these Non-GAAP financial measures exclude: non-cash stock-based compensation expense, amortization expense related to acquired intangible assets, amortization expense related to acquisition-date inventory fair value step-up, stock based compensation expense related to the acceleration of vesting of equity awards for Soleno employees, changes in fair value of equity investments, acquisition-related transaction and integration costs, gains on sales of businesses, net of transaction costs, other divestiture-related transaction costs, changes in foreign currency exchange rates and certain adjustments to income tax expense. These Non-GAAP financial measures are provided as a complement to results provided in accordance with GAAP as management believes these Non-GAAP financial measures are useful to investors because they help indicate underlying trends in the Company's business, are important in comparing current results with prior period results and provide additional information regarding the Company's financial position. Management also uses these Non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally and to manage the Company's business and evaluate its performance. The Company provides guidance regarding combined R&D and SG&A expenses on both a GAAP and a Non-GAAP basis. A reconciliation of these GAAP financial results to Non-GAAP financial results is included in the attached financial information. In connection with the Soleno acquisition, this press release also includes unaudited pro forma full quarter VYKAT XR net product sales and total revenue, Non-GAAP financial measures, which management uses, and believes is useful to investors, to provide supplemental information regarding VYKAT XR net product sales for the full second quarter of 2026, including the period from April 1, 2026 through May 17, 2026, prior to the closing of the acquisition on May 18, 2026. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: our business strategy, objectives, and future development plans; the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; successfully commercializing CRENESSITY and VYKAT XR; our financial and operating performance, including our future revenues, expenses, or profits; our full year 2026 financial guidance; our acquisition of Soleno Therapeutics, including the prospective benefits of the acquisition, and our strategy, plans, objectives, expectations (financial or otherwise) and intentions with respect to our future financial results, growth potential and anticipated product portfolio in connection with the acquisition; our collaborative partnerships; clinical and scientific data updates for our products and product candidates, including observations regarding clinical outcomes, safety, and tolerability; expected future clinical and regulatory milestones; and the timing of the initiation and/or completion of our clinical, regulatory, and other development activities and those of our collaboration partners. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements, include but are not limited to the following: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general; risks and uncertainties associated with the commercialization of our products; risks related to our ability to realize the anticipated benefits of the acquisition of Soleno Therapeutics, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period and that we will not be able to integrate Soleno Therapeutics' business successfully or that such integration may be more difficult, time-consuming or costly than expected, disruption from the acquisition, making it more difficult to conduct business as usual or maintain relationships with employees, customers, suppliers, other business partners or governmental entities, unknown or inestimable liabilities, the risk of litigation and/or regulatory actions related to the acquisition, and the degree and pace of market uptake of VYKAT XR; risks related to the development of our product candidates; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with government and third-party regulatory and/or policy efforts which may, among other things, impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products; risks associated with competition from other therapies or products, including potential generic entrants for our products; risks associated with our ability to manage the growth of our organization; and other risks described in our periodic reports filed with the Securities and Exchange Commission. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than as required by law. TABLE 1 NEUROCRINE BIOSCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (unaudited, in millions, except per share data) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Revenues: Net product sales $ 954.3 $ 682.0 $ 1,765.3 $ 1,245.7 Collaboration revenues 4.7 5.5 8.2 14.4 Total revenues 959.0 687.5 1,773.5 1,260.1 Operating expenses: Cost of revenues, excluding amortization of acquired intangible assets 23.2 10.3 36.9 18.5 Research and development 326.7 244.3 622.9 507.5 Acquired in-process research and development 1.5 — 22.7 0.1 Selling, general, and administrative 439.7 286.3 758.2 562.8 Amortization of acquired intangible assets 16.4 1.0 16.5 2.0 Gain on sale of business, net of transaction costs — — (28.6) — Total operating expenses 807.5 541.9 1,428.6 1,090.9 Operating income 151.5 145.6 344.9 169.2 Other income (expense): Interest expense (2.9) — (2.9) — Unrealized gain (loss) on equity investments 1.2 (6.7) 26.5 (37.3) Investment income and other, net 12.4 20.6 40.5 42.3 Total other income (expense), net 10.7 13.9 64.1 5.0 Income before provision for income taxes 162.2 159.5 409.0 174.2 Provision for income taxes 17.8 52.0 66.7 58.8 Net income $ 144.4 $ 107.5 $ 342.3 $ 115.4 Earnings per share, basic $ 1.43 $ 1.09 $ 3.40 $ 1.16 Earnings per share, diluted $ 1.39 $ 1.06 $ 3.30 $ 1.13 Weighted average common shares outstanding, basic 101.0 99.0 100.8 99.3 Weighted average common shares outstanding, diluted 104.2 101.0 103.8 101.8 TABLE 2 NEUROCRINE BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in millions) June 30, 2026 December 31, 2025 Cash, cash equivalents, and marketable securities $ 389.8 $ 1,480.4 Accounts receivable 887.0 686.8 Inventory 104.2 69.0 Other current assets 256.5 286.5 Total current assets 1,637.5 2,522.7 Noncurrent inventory 149.1 — Noncurrent marketable securities 91.9 1,063.0 Right-of-use assets 448.0 455.4 Equity investments 147.3 120.8 Property and equipment, net 90.5 89.8 Intangible assets, net 2,226.0 4.7 Goodwill 500.6 6.1 Deferred tax assets 8.9 320.3 Other noncurrent assets 59.3 48.7 Total assets $ 5,359.1 $ 4,631.5 Total current liabilities 874.5 743.4 Deferred tax liabilities 91.5 — Noncurrent operating lease liabilities 401.8 415.3 Other noncurrent liabilities 297.7 219.7 Stockholders' equity 3,693.6 3,253.1 Total liabilities and stockholders' equity $ 5,359.1 $ 4,631.5 TABLE 3 NEUROCRINE BIOSCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS (unaudited, in millions, except per share data) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 GAAP net income 1 $ 144.4 $ 107.5 $ 342.3 $ 115.4 Adjustments: Stock-based compensation expense 65.0 52.8 122.2 105.6 Acceleration of stock-based compensation expense and related taxes 2 60.1 — 60.1 — Acquisition-related employee compensation and severance costs 21.9 — 21.9 — Amortization of inventory fair value step-up 3 3.0 — 3.0 — Amortization of acquired intangible assets 4 16.4 1.0 16.5 2.0 Acquisition/divestiture-related transaction and integration costs 45.0 — 48.7 — Gain on sale of business, net of transaction costs 5 — — (28.6) — Changes in fair values of equity investments 6 (1.2) 6.7 (26.5) 37.3 Other 0.7 0.8 1.3 2.3 Income tax effect related to reconciling items 7 (58.6) (2.6) (63.7) (24.8) Non-GAAP net income 1 $ 296.7 $ 166.2 $ 497.2 $ 237.8 Diluted earnings per share: GAAP $ 1.39 $ 1.06 $ 3.30 $ 1.13 Non-GAAP $ 2.85 $ 1.65 $ 4.79 $ 2.34 Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Cost of Revenues: GAAP cost of revenues $ 23.2 $ 10.3 $ 36.9 $ 18.5 Adjustments: Acceleration of stock-based compensation expense and related taxes 2 1.8 — 1.8 — Acquisition-related employee compensation and severance costs 0.2 — 0.2 — Amortization of inventory fair value step-up 3 3.0 — 3.0 — Non-GAAP cost of revenues $ 18.2 $ 10.3 $ 31.9 $ 18.5 Research and Development: GAAP R&D $ 326.7 $ 244.3 $ 622.9 $ 507.5 Adjustments: Stock-based compensation expense 27.5 21.6 51.7 44.6 Acceleration of stock-based compensation expense and related taxes 2 18.1 — 18.1 — Acquisition-related employee compensation and severance costs 5.0 — 5.0 — Non-GAAP R&D $ 276.1 $ 222.7 $ 548.1 $ 462.9 Selling, General, and Administrative: GAAP SG&A $ 439.7 $ 286.3 $ 758.2 $ 562.8 Adjustments: Stock-based compensation expense 37.5 31.2 70.5 61.0 Acceleration of stock-based compensation expense and related taxes 2 40.2 — 40.2 — Acquisition-related employee compensation and severance costs 16.7 — 16.7 — Acquisition/divestiture-related transaction and integration costs 39.9 — 43.6 — Other 0.5 0.5 1.1 1.9 Non-GAAP SG&A $ 304.9 $ 254.6 $ 586.1 $ 499.9 Amortization of Acquired Intangible Assets: GAAP amortization of acquired intangible assets $ 16.4 $ 1.0 $ 16.5 $ 2.0 Adjustments: Amortization of acquired intangible assets 4 16.4 1.0 16.5 2.0 Non-GAAP amortization of acquired intangible assets $ — $ — $ — $ — Gain on Sale of Business, Net of Transaction Costs: GAAP gain on sale of business, net of transaction costs $ — $ — $ (28.6) $ — Adjustments: Gain on sale of business, net of transaction costs 5 — — (28.6) — Non-GAAP gain on sale of business, net of transaction costs $ — $ — $ — $ — Other Income (Expense): GAAP other income, net $ 10.7 $ 13.9 $ 64.1 $ 5.0 Adjustments: Changes in fair values of equity investments 6 (1.2) 6.7 (26.5) 37.3 Acquisition/divestiture-related transaction and integration costs 5.1 — 5.1 — Other 0.2 0.3 0.2 0.4 Non-GAAP other income, net $ 14.8 $ 20.9 $ 42.9 $ 42.7 1. Includes the following expenses: Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Milestones (R&D) $ 0.3 $ 15.1 $ 22.9 $ 60.5 Acquired in-process research and development (IPR&D) $ 1.5 $ — $ 22.7 $ 0.1 2. Relates to the acceleration of vesting of equity awards for Soleno employees which vested in full upon the closing of the transaction. 3. Relates to amortization expense associated with recording approximately $168 million of VYKAT XR inventory fair value step-up. 4. Primarily relates to amortization of acquired intangible assets associated with the recording of approximately $2.2 billion of intellectual property related to VYKAT XR, which will be amortized over 16 years. 5. Reflects a pre-tax gain, net of transaction costs, recognized on the sale of Neurocrine Group Limited in January 2026. 6. Reflects periodic fluctuations in the fair values of equity investments. 7. Estimated income tax effect of Non-GAAP reconciling items are calculated using applicable statutory tax rates, taking into consideration any valuation allowance. In addition, Non-GAAP tax expense may also be affected by certain non-recurring, non-operating, or discrete tax items. SOURCE Neurocrine Biosciences, Inc. |
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2026-07-29 16:06
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2026-07-29 10:16
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Neurocrine (NBIX) Q2 Earnings Preview: What You Should Know Beyond the Headline Estimates | FMP Stock News | |
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Wall Street analysts expect Neurocrine Biosciences (NBIX - Free Report) to post quarterly earnings of $2.26 per share in its upcoming report, which indicates a year-over-year increase of 113.2%. Revenues are expected to be $901.54 million, up 31.1% from the year-ago quarter.The consensus EPS estimate for the quarter has undergone an upward revision of 0.2% in the past 30 days, bringing it to its present level. This represents how the covering analysts, as a whole, have reassessed their initial estimates during this timeframe. Ahead of a company's earnings disclosure, it is crucial to give due consideration to changes in earnings estimates. These revisions serve as a noteworthy factor in predicting potential investor reactions to the stock. Numerous empirical studies consistently demonstrate a strong relationship between trends in earnings estimate revision and the short-term price performance of a stock. While it's common for investors to rely on consensus earnings and revenue estimates for assessing how the business may have performed during the quarter, exploring analysts' forecasts for key metrics can yield valuable insights. With that in mind, let's delve into the average projections of some Neurocrine metrics that are commonly tracked and projected by analysts on Wall Street. The combined assessment of analysts suggests that 'Revenues- Product sales, net' will likely reach $881.08 million. The estimate indicates a year-over-year change of +29.2%. Based on the collective assessment of analysts, 'Revenues- Collaboration revenue' should arrive at $6.02 million. The estimate points to a change of +9.4% from the year-ago quarter. The consensus among analysts is that 'Revenues- Product sales, net- INGREZZA' will reach $628.59 million. The estimate indicates a change of +0.7% from the prior-year quarter. View all Key Company Metrics for Neurocrine here>>> Over the past month, Neurocrine shares have recorded returns of +8.5% versus the Zacks S&P 500 composite's +1.9% change. Based on its Zacks Rank #2 (Buy), NBIX will likely outperform the overall market in the upcoming period. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> . |
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2026-07-27 18:28
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2026-07-27 12:30
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Neurocrine Gears Up to Report Q2 Earnings: What's in the Cards? | FMP Stock News | |
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Key Takeaways NBIX is expected to post Q2 revenues of $901.54 million and earnings of $2.26 per share.Neurocrine expects Ingrezza and Crenessity to support quarterly growth through demand and adoption.NBIX investors will watch pipeline updates and the integration of newly acquired Vykat XR. Neurocrine Biosciences (NBIX - Free Report) is scheduled to report second-quarter 2026 results on July 30, after market close. We expect investors to focus on the sales performance of NBIX’s marketed products and other pipeline updates when the company reports quarterly results.The Zacks Consensus Estimate for second-quarter 2026 revenues is pegged at $901.54 million, while the same for earnings is pegged at $2.26 per share. Over the past six months, shares of NBIX have risen 30.5% against the industry’s 4.1% decline. Image Source: Zacks Investment Research Let’s see how things might have shaped up for NBIX in the to-be-reported quarter. Factors Likely to Influence NBIX’s Q2 ResultsNeurocrine’s top line primarily comprises product sales from Ingrezza and Crenessity with only a modest contribution from other revenue streams. Ingrezza, the company's flagship VMAT2 inhibitor, continues to anchor revenue growth with its leadership in the tardive dyskinesia market, while benefiting from its expanded indication in Huntington's disease chorea. Meanwhile, Crenessity is emerging as an important growth driver following its FDA approval in late 2024 for use as an adjunctive treatment for classic congenital adrenal hyperplasia (CAH) in adults and children aged four years and older. We expect Ingrezza to sustain its solid commercial momentum in the upcoming quarter, supported by robust prescription demand. Management's reaffirmation of its full-year sales guidance of $2.7-$2.8 billion reflects continued confidence in the product's growth trajectory. Meanwhile, Crenessity is expected to deliver another quarter of sequential growth, driven by increasing physician adoption, expanding reimbursement coverage and rising patient uptake. Collectively, these products are likely to underpin Neurocrine's second-quarter commercial performance. Beyond its commercial portfolio, investors are likely to focus on updates across Neurocrine's diversified neuroscience pipeline, which remains a key driver of the company's long-term growth strategy. Particular attention will be on the phase III development of direclidine for schizophrenia, alongside its mid-stage evaluation in bipolar mania, as well as the late-stage development of osavampator for major depressive disorder with cognitive impairment. Investors will also look for updates on Crenessity's expansion, following the initiation of a phase II study in younger pediatric patients (less than four years) with classic CAH and the completion of enrollment in a separate phase II study in the European Union involving children from birth to under two years of age. Another area of focus will be the Soleno Therapeutics acquisition, completed in May 2026. The transaction added Vykat XR (diazoxide choline), the first and only FDA-approved treatment for hyperphagia associated with Prader-Willi syndrome in adults and pediatric patients aged four years and older, to Neurocrine's commercial portfolio. Supported by patent protection extending into the mid-2040s, the acquisition is expected to strengthen the company's commercial platform and enhance its long-term growth profile. Earnings Surprise HistoryNeurocrine has a mixed history of earnings surprises. The company’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, delivering an average surprise of 9.08%. In the last reported quarter, the company delivered an earnings surprise of 15.48%. Earnings Whispers for NBIXOur proven model does not conclusively predict an earnings beat for NBIX this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. That is not the case here, as you will see below. You can uncover the best stocks to buy or sell before they are reported with our Earnings ESP Filter. Earnings ESP: Neurocrine has an Earnings ESP of -7.61% as the Most Accurate Estimate currently stands at $2.08 per share and the Zacks Consensus Estimate of earnings is pegged at $2.26. Zacks Rank: Neurocrine currently carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here. Stocks to ConsiderHere are a few stocks worth considering from the healthcare space, as our model shows that these have the right combination of elements to beat on earnings this reporting cycle. Harmony Biosciences (HRMY - Free Report) has an Earnings ESP of +14.14% and sports a Zacks Rank #1 at present. Shares of HRMY have lost 4.2% over the past six months. The company’s earnings missed estimates in each of the trailing four quarters, delivering a negative average surprise of 25.16%. ACADIA Pharmaceuticals (ACAD - Free Report) has an Earnings ESP of +25.00% and carries a Zacks Rank #2 at present. Shares of ACAD have lost 3.1% over the past six months. The company’s earnings beat estimates in three of the trailing four quarters but missed in the remaining quarter, delivering an average surprise of 20.83%. Agios Pharmaceuticals (AGIO - Free Report) has an Earnings ESP of +12.67% and holds a Zacks Rank #3 at present. Shares of AGIO have risen 28.4% over the past six months. The company’s earnings beat estimates in three of the trailing four quarters but missed in the remaining quarter, delivering an average surprise of 2.39%. |
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2026-07-23 20:48
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2026-07-23 16:05
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Neurocrine Biosciences Announces Key Leadership Hiring, Promotions | FMP Stock News | |
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, /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the appointment of three Senior Vice Presidents, further strengthening its leadership team as the company executes its next phase of growth, expands its commercial portfolio and advances one of the industry's strongest neuroscience pipelines. These appointments reflect Neurocrine's continued evolution into a diversified, multi-product biopharmaceutical company positioned to deliver sustainable long-term growth.The appointments include Bret Paulson, who joins the company as Senior Vice President, Market Access, and the promotions of David Bradfute to Senior Vice President and Global Head of Intellectual Property, and Aaron Vosburgh to Senior Vice President, Finance and Accounting. "Neurocrine is entering a new phase of growth as we expand our commercial portfolio, advance one of the industry's most productive pipelines and prepare to bring more innovative medicines to patients," said Kyle W. Gano, Ph.D., Chief Executive Officer, Neurocrine Biosciences. "Successfully executing on that opportunity requires exceptional leadership across every function of our company. Bret, Aaron and David each bring outstanding expertise, judgment and a proven ability to build high-performing organizations. Together, they strengthen our ability to execute today while positioning Neurocrine for the opportunities ahead, ultimately enabling us to deliver greater value for patients, healthcare providers and shareholders." Bret Paulson is an accomplished leader with nearly 30 years of experience in the biopharmaceutical and insurance industries. He will be responsible for shaping and driving Neurocrine's global market access vision, strategy and execution to provide patient access to the company's current and future medicines, while strengthening payer partnerships and reimbursement strategies across an increasingly diversified portfolio. He joins Neurocrine after more than six years at Otsuka Pharmaceutical Companies, most recently as Vice President and Head of Market Access & Channel Strategy. Prior to that, he was Area Vice President, National Accounts at Horizon after working in the commercial organizations at Schering Plough, Eli Lilly & Company, and Amgen. Paulson earned a Bachelor of Arts in Asian studies from Brigham Young University. David Bradfute, who joined Neurocrine in 2017, has been promoted to Senior Vice President and Global Head of Intellectual Property and will also serve as Managing Director of Neurocrine Switzerland GmbH, based in the company's Basel, Switzerland, office. In his expanded role, Bradfute will lead the company's global intellectual property strategy and oversee the protection of Neurocrine's products, diversified portfolio, technology platforms, and scientific innovations. Before joining Neurocrine, Bradfute held leadership roles across the healthcare and life sciences industry, including a 13-year career at Arena Pharmaceuticals and later as Head of Legal and Intellectual Property at Sanford Burnham Prebys Medical Discovery Institute. He earned a bachelor's degree in biochemistry from Swarthmore College, master's and doctoral degrees in biological sciences from Stanford University, and a Juris Doctor from Stanford Law School. Aaron Vosburgh, an eight-year Neurocrine employee, will oversee enterprise financial strategy, partnering with executive leadership to align capital allocation, long-range financial planning and portfolio investments with Neurocrine's strategy to advance innovation and deliver new therapies to patients. While at Neurocrine, he has helped build, scale and strengthen the company's accounting, finance, tax, treasury, and financial planning and analysis capabilities while serving as a strategic advisor on many of the company's most important financial decisions. Prior to joining Neurocrine, Vosburgh held senior finance leadership roles at Applied Proteomics, Synthetic Genomics, Verenium Corporation, and Natural Alternatives International, following the start of his career at Ernst & Young. He is a Certified Public Accountant (inactive) and earned a Bachelor of Arts in Accounting from the University of San Diego. About Neurocrine Biosciences Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, and YOU DESERVE BRAVE SCIENCE, are registered trademarks of Neurocrine Biosciences, Inc. SOURCE Neurocrine Biosciences, Inc. |
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2026-07-23 15:58
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2026-07-23 11:01
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Neurocrine Biosciences (NBIX) Earnings Expected to Grow: What to Know Ahead of Next Week's Release | FMP Stock News | |
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Wall Street expects a year-over-year increase in earnings on higher revenues when Neurocrine Biosciences (NBIX - Free Report) reports results for the quarter ended June 2026. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on July 30. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. Zacks Consensus EstimateThis biopharmaceutical company is expected to post quarterly earnings of $2.24 per share in its upcoming report, which represents a year-over-year change of +111.3%. Revenues are expected to be $894.32 million, up 30.1% from the year-ago quarter. Estimate Revisions TrendThe consensus EPS estimate for the quarter has remained unchanged over the last 30 days. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). How Have the Numbers Shaped Up for Neurocrine?For Neurocrine, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +3.77%. On the other hand, the stock currently carries a Zacks Rank of #1. So, this combination indicates that Neurocrine will most likely beat the consensus EPS estimate. Does Earnings Surprise History Hold Any Clue?While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Neurocrine would post earnings of $1.68 per share when it actually produced earnings of $1.94, delivering a surprise of +15.48%. Over the last four quarters, the company has beaten consensus EPS estimates three times. Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Neurocrine appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. An Industry Player's Expected ResultsAnother stock from the Zacks Medical - Drugs industry, Ionis Pharmaceuticals (IONS - Free Report) , is soon expected to post loss of $0.91 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of -205.8%. Revenues for the quarter are expected to be $189.93 million, down 58% from the year-ago quarter. The consensus EPS estimate for Ionis Pharmaceuticals has been revised 4.1% lower over the last 30 days to the current level. However, a higher Most Accurate Estimate has resulted in an Earnings ESP of +3.30%. This Earnings ESP, combined with its Zacks Rank #4 (Sell), makes it difficult to conclusively predict that Ionis Pharmaceuticals will beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. |
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2026-07-22 13:32
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2026-07-22 04:17
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California Public Employees Retirement System Purchases 25,620 Shares of Neurocrine Biosciences, Inc. $NBIX | FMP Stock News | |
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Posted by Defense World Staff on Jul 22nd, 2026California Public Employees Retirement System raised its position in shares of Neurocrine Biosciences, Inc. (NASDAQ:NBIX – Free Report) by 13.0% in the 1st quarter, according to the company in its most recent disclosure with the SEC. The fund owned 222,441 shares of the company’s stock after buying an additional 25,620 shares during the quarter. California Public Employees Retirement System owned about 0.22% of Neurocrine Biosciences worth $29,304,000 at the end of the most recent reporting period. A number of other institutional investors have also modified their holdings of the company. AQR Capital Management LLC grew its position in shares of Neurocrine Biosciences by 83.7% in the 3rd quarter. AQR Capital Management LLC now owns 2,773,648 shares of the company’s stock worth $388,435,000 after buying an additional 1,263,633 shares during the last quarter. Norges Bank purchased a new stake in Neurocrine Biosciences during the fourth quarter valued at approximately $162,664,000. UBS Group AG lifted its position in Neurocrine Biosciences by 169.8% during the fourth quarter. UBS Group AG now owns 983,528 shares of the company’s stock valued at $139,494,000 after acquiring an additional 618,956 shares during the last quarter. Zurich Insurance Group Ltd FI purchased a new stake in Neurocrine Biosciences during the fourth quarter valued at approximately $65,162,000. Finally, Two Sigma Investments LP acquired a new stake in Neurocrine Biosciences in the third quarter valued at approximately $48,791,000. 92.59% of the stock is currently owned by institutional investors. Neurocrine Biosciences Trading Up 3.5% NASDAQ:NBIX opened at $179.05 on Wednesday. Neurocrine Biosciences, Inc. has a twelve month low of $122.14 and a twelve month high of $181.18. The company has a market cap of $18.00 billion, a PE ratio of 27.59, a P/E/G ratio of 0.69 and a beta of 0.39. The company’s 50 day moving average is $164.65 and its two-hundred day moving average is $144.28. Analyst Upgrades and Downgrades Several equities analysts have issued reports on NBIX shares. Needham & Company LLC reaffirmed a “buy” rating and issued a $185.00 price target on shares of Neurocrine Biosciences in a report on Monday, April 6th. Wall Street Zen raised Neurocrine Biosciences from a “buy” rating to a “strong-buy” rating in a research report on Saturday, April 25th. Guggenheim raised their price objective on Neurocrine Biosciences from $175.00 to $200.00 and gave the stock a “buy” rating in a research report on Tuesday. BMO Capital Markets boosted their target price on Neurocrine Biosciences from $144.00 to $170.00 and gave the stock a “market perform” rating in a research note on Monday, July 13th. Finally, Weiss Ratings lowered Neurocrine Biosciences from a “buy (b)” rating to a “buy (b-)” rating in a research report on Friday, July 10th. Two research analysts have rated the stock with a Strong Buy rating, eighteen have issued a Buy rating and three have assigned a Hold rating to the stock. According to data from MarketBeat.com, Neurocrine Biosciences presently has an average rating of “Moderate Buy” and an average price target of $194.05. Read Our Latest Analysis on Neurocrine Biosciences Insider Buying and Selling at Neurocrine Biosciences In other news, insider Ingrid Delaet sold 4,367 shares of Neurocrine Biosciences stock in a transaction on Friday, July 10th. The shares were sold at an average price of $181.02, for a total transaction of $790,514.34. Following the completion of the sale, the insider directly owned 16,225 shares in the company, valued at approximately $2,937,049.50. The trade was a 21.21% decrease in their ownership of the stock. The transaction was disclosed in a filing with the SEC, which is accessible through the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, insider Julie Cooke sold 36,937 shares of the business’s stock in a transaction on Tuesday, June 2nd. The shares were sold at an average price of $156.22, for a total transaction of $5,770,298.14. Following the sale, the insider directly owned 22,374 shares in the company, valued at $3,495,266.28. This trade represents a 62.28% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. In the last ninety days, insiders sold 394,172 shares of company stock valued at $62,221,181. Company insiders own 4.60% of the company’s stock. Neurocrine Biosciences Profile (Free Report) Neurocrine Biosciences (NASDAQ: NBIX) is a biopharmaceutical company based in San Diego, California, focused on developing treatments for neurological, endocrine and neuropsychiatric disorders. Since its founding in 1992, the company has pursued a research‐driven strategy aimed at addressing unmet medical needs in movement disorders, reproductive health and central nervous system conditions. Neurocrine’s operations encompass drug discovery, clinical development and commercialization activities. The company’s lead marketed product, Ingrezza™ (valbenazine), is indicated for the treatment of tardive dyskinesia, a movement disorder associated with long-term antipsychotic use. Featured Stories Five stocks we like better than Neurocrine Biosciences Confidence Is Back, But Earnings Show the Consumer Is Being Picky AeroVironment’s Stock Is Down, But Drone Demand Is Taking Off 3M’s Redemption Arc: Can Q2 Earnings Change the Narrative? 3 Photonics Companies Making Quantum Tech Possible Want to see what other hedge funds are holding NBIX? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Neurocrine Biosciences, Inc. (NASDAQ:NBIX – Free Report). Receive News & Ratings for Neurocrine Biosciences Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Neurocrine Biosciences and related companies with MarketBeat.com's FREE daily email newsletter. « PREVIOUS HEADLINEIDEX Corporation $IEX Shares Sold by California Public Employees Retirement System NEXT HEADLINE »Andra AP fonden Buys 13,330 Shares of Airbnb, Inc. $ABNB |
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2026-07-21 20:42
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2026-07-21 16:05
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Neurocrine Biosciences Appoints Samir Siddhanti Chief Business Officer | FMP Stock News | |
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, /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the appointment of Samir Siddhanti as Chief Business Officer and a member of the company's executive Management Committee.As Chief Business Officer, Siddhanti will lead Neurocrine's enterprise growth strategy, overseeing business development, corporate strategy, alliance management and program management to maximize the value of the company's expanding pipeline through both internal innovation and strategic external opportunities. Since joining Neurocrine in 2017, Siddhanti has assumed leadership roles of increasing responsibility across business development, alliance management and corporate strategy. Most recently serving as Vice President, Business Development, he has led numerous strategic transactions and partnerships that have expanded Neurocrine's pipeline and commercial portfolio, including the company's recent $2.9 billion acquisition of Soleno Therapeutics. He also serves as Program Team Leader for direclidine, providing strategic leadership for the program's development in schizophrenia and bipolar disorder, while helping shape the company's broader muscarinic portfolio strategy. Siddhanti's unique combination of strategic, transactional and development leadership reflects Neurocrine's integrated approach to building a differentiated biotechnology company and positions him well to help drive the company's next phase of growth. "Throughout his tenure, Samir has become one of the company's key leaders, helping shape Neurocrine's long-term growth strategy through disciplined portfolio prioritization, thoughtful capital allocation and the execution of transformative business development initiatives," said Kyle W. Gano, Ph.D., Chief Executive Officer, Neurocrine Biosciences. "As he steps into this expanded role, I look forward to his continued leadership as we advance our pipeline, pursue new opportunities and work to bring meaningful new therapies to patients with great needs." "I've had the privilege of working alongside exceptional colleagues throughout my time at Neurocrine, and I'm honored by the opportunity to serve as Chief Business Officer," Siddhanti said. "I'm grateful for the trust Kyle and the leadership team have placed in me. What makes Neurocrine special is our people, our science and our shared commitment to improving patients' lives. I look forward to continuing to work across the organization to execute our strategy, strengthen our pipeline and help bring meaningful new medicines to patients." Prior to joining Neurocrine, Siddhanti was a member of the biotechnology equity research team at Goldman Sachs. He holds Bachelor of Science and Master of Science degrees in Management Science and Engineering from Stanford University. About Neurocrine Biosciences Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, and YOU DESERVE BRAVE SCIENCE, are registered trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the Company's ability to execute its growth strategy, maximize the value of its pipeline and commercial portfolio through internal innovation and strategic and external opportunities, and bring meaningful new therapies to patients. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: challenges associated with organizational changes and the Company's ability to effectively execute its strategic priorities; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general; risks and uncertainties associated with the commercialization of our products; risks related to our ability to realize the anticipated benefits of the acquisition of Soleno Therapeutics, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period and that we will not be able to integrate Soleno Therapeutics' business successfully or that such integration may be more difficult, time-consuming or costly than expected; risks related to the development of our product candidates; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with government and third-party regulatory and/or policy efforts which may, among other things, impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products; risks associated with competition from other therapies or products, including potential generic entrants for our products; risks associated with our ability to manage the growth of our organization; and other risks described in our periodic reports filed with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than as required by law. © 2026 Neurocrine Biosciences, Inc. All Rights Reserved SOURCE Neurocrine Biosciences, Inc. |
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2026-07-15 20:36
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2026-07-15 16:00
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NVIDIA & 2 Best Earnings Growth Stocks to Buy for 2H 2026 | FMP Stock News | |
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Key Takeaways NVIDIA combines strong earnings growth expectations with positive estimate revisions for the current year. Neurocrine Biosciences qualified with rising earnings estimates and projected earnings growth of 48.4%. Ball made the screen on improving earnings estimates and expected 11.8% earnings growth this year. Earnings growth is essential for organizations of all sizes because sustained profitability is key to survival. To calculate earnings, examine a company’s revenues over a certain period and subtract the production costs. A company’s earnings have a significant influence on its share price, with earnings expectations playing a key role in determining market performance. Against this backdrop, NVIDIA Corporation (NVDA - Free Report) , Neurocrine Biosciences, Inc. (NBIX - Free Report) and Ball Corporation (BALL - Free Report) are delivering strong and impressive earnings growth, making them compelling investment opportunities for the second half of this year. Earnings Estimates & Share Price Movements We have frequently seen stock prices decline despite earnings growth or rally after an earnings decline. This is largely the result of a company’s earnings failing to meet market expectations. Earnings estimates reflect analysts’ views on factors such as sales growth, product demand, the competitive industry environment, profit margins, and cost control. Consequently, earnings estimates are a valuable tool for making investment decisions. They also help analysts evaluate cash flow to determine a firm's fair value. Thus, investors should be on the lookout for stocks ready to make a big move. Such stocks should have a history of earnings growth and rising quarterly and annual earnings estimates. Research Wizard: Your Shortcut to Finding Winning StocksTo shortlist stocks that have striking earnings growth and positive estimate revisions, we have added the following parameters: Zacks Rank less than or equal to 2 (Only Zacks' 'Buys' and 'Strong Buys' are allowed. With the Zacks Rank proving itself to be one of the best rating systems out there, this is a great way to start things off.) 5-Year Historical EPS Growth (%) greater than X-Industry (stocks with a strong EPS growth history). % Change EPS F(0)/F(-1) greater than or equal to 5 (companies that saw year-over-year earnings growth of 5% or more in the last reported fiscal). % Change Q1 Estimates over the last 4 weeks greater than zero (stocks that have seen their current quarter earnings estimates revised higher in the last 4 weeks). % Change F1 Estimates over the last 1 week greater than zero (stocks that have seen their annual earnings estimates revised higher in the last 1 week). % Change F1 Estimates over the last 4 weeks greater than zero (stocks that have seen their annual earnings estimates revised higher in the last 4 weeks). The above criteria narrowed the universe of around 7,839 stocks to only 24. Here are the top three stocks: NVIDIA NVIDIA is a leading AI infrastructure company with operations across the United States, Taiwan, China, Hong Kong, Europe and other global markets. The company’s expected earnings growth rate for the current year is 90.8%. NVDA currently has a Zacks Rank #2 (Buy) (read more: Missed NVIDIA's 900% Run? Micron Could Be AI's Next Big Winner). Neurocrine Biosciences Neurocrine Biosciences is a biopharmaceutical company focused on developing treatments for neurological, neuroendocrine and psychiatric disorders. The company’s expected earnings growth rate for the current year is 48.4%. NBIX currently has a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Ball Ball supplies aluminum packaging solutions for the beverage, personal care and household products industries worldwide. The company’s expected earnings growth rate for the current year is 11.8%. BALL currently has a Zacks Rank #2. |
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2026-07-14 18:12
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2026-07-14 13:21
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Can Neurocrine (NBIX) Run Higher on Rising Earnings Estimates? | FMP Stock News | |
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Neurocrine Biosciences (NBIX - Free Report) could be a solid choice for investors given the company's remarkably improving earnings outlook. While the stock has been a strong performer lately, this trend might continue since analysts are still raising their earnings estimates for the company.The rising trend in estimate revisions, which is a result of growing analyst optimism on the earnings prospects of this biopharmaceutical company, should get reflected in its stock price. After all, empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements. This insight is at the core of our stock rating tool -- the Zacks Rank. The five-grade Zacks Rank system, which ranges from a Zacks Rank #1 (Strong Buy) to a Zacks Rank #5 (Strong Sell), has an impressive externally-audited track record of outperformance, with Zacks #1 Ranked stocks generating an average annual return of +25% since 2008. Consensus earnings estimates for the next quarter and full year have moved considerably higher for Neurocrine Biosciences, as there has been strong agreement among the covering analysts in raising estimates. The chart below shows the evolution of forward 12-month Zacks Consensus EPS estimate: 12 Month EPS Current-Quarter Estimate RevisionsThe earnings estimate of $2.25 per share for the current quarter represents a change of +112.3% from the number reported a year ago. Over the last 30 days, two estimates have moved higher for Neurocrine compared to no negative revisions. As a result, the Zacks Consensus Estimate has increased 6.07%. Current-Year Estimate RevisionsThe company is expected to earn $9.48 per share for the full year, which represents a change of +48.4% from the prior-year number. In terms of estimate revisions, the trend for the current year also appears quite encouraging for Neurocrine. Over the past month, two estimates have moved higher compared to no negative revisions, helping the consensus estimate increase 5.05%. Favorable Zacks RankThanks to promising estimate revisions, Neurocrine currently carries a Zacks Rank #1 (Strong Buy). The Zacks Rank is a tried-and-tested rating tool that helps investors effectively harness the power of earnings estimate revisions and make the right investment decision. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Our research shows that stocks with Zacks Rank #1 (Strong Buy) and 2 (Buy) significantly outperform the S&P 500. Bottom LineNeurocrine shares have added 9.2% over the past four weeks, suggesting that investors are betting on its impressive estimate revisions. So, you may consider adding it to your portfolio right away to benefit from its earnings growth prospects. |
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2026-07-10 18:15
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2026-07-10 11:58
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Neurocrine Shares Hit Highs on Sales Spike, Strong Pipeline | FMP Stock News | |
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Biopharmaceutical firm Neurocrine Biosciences, Inc. (NBIX) up over 35% in a year and 17% since outlier inflows in May.PREMIUM Read what the experts are trading this weekExclusive analysis from FXEmpire top analysts — curated insights you won't find on the free site. In-depth analysis Curated reports Top analysts Unlock Premium NBIX is a biopharmaceutical company that discovers, develops, and markets drugs to treat neurological, neuroendocrine, and neuropsychiatric disorders. The company’s first-quarter fiscal 2026 earnings report showed over $800 million in net product sales, led by INGREZZA’s 44% year-over-year growth, net income of around $200 million, and a strong product pipeline (12 current programs with five more slated for launch this year). It’s no wonder NBIX shares are up 27% this year, and they could rise more. MoneyFlows data shows how Big Money investors are again betting heavily on the stock. Neurocrine Attracting Institutional Capital Institutional volumes reveal plenty. In the last year, NBIX has enjoyed strong investor demand, which we believe to be institutional support. Each green bar signals unusually large volumes in NBIX shares. They reflect our proprietary inflow signal, pushing the stock higher: NBIX’s flurry of institutional inflows beginning in May have sent the share price from roughly $135 to $180. Source: www.moneyflows.com Plenty of health care names are under accumulation right now. But there’s a powerful fundamental story happening with Neurocrine. Neurocrine Fundamental Analysis Institutional support and a healthy fundamental backdrop make this company worth investigating. As you can see, NBIX has had strong sales and earnings growth: 3-year sales growth rate (+24.3%) 3-year EPS growth rate (+44.3%) Source: FactSet Also, EPS is estimated to ramp higher this year by +27%. Now it makes sense why the stock has been generating Big Money interest. NBIX has a track record of strong financial performance. Marrying great fundamentals with MoneyFlows software has found some big winning stocks over the long term. Neurocrine has been a top-rated stock at MoneyFlows for years. That means the stock has unusual buy pressure and growing fundamentals. We have a ranking process that showcases stocks like this on a weekly basis. In the last few months, NBIX has drawn four outlier inflow signals. The blue bars below show when NBIX was a top pick on the Outlier 20 report in the last decade…Big Money is a believer: NBIX has been supported by many outlier inflow signals over the last decade, reflecting Big Money support. Source: www.moneyflows.com Tracking unusual volumes reveals the power of money flows. This is a trait that most outlier stocks exhibit…the best of the best. Big Money demand drives stocks upward. Neurocrine Price Prediction The NBIX action isn’t new at all. Big Money buying in the shares is signaling to take notice. Given the historical gains in share price and strong fundamentals, this stock could be worth a spot in a diversified portfolio. Disclosure: the author holds no position in NBIX at the time of publication. If you are a Registered Investment Advisor (RIA) or are a serious investor, take your investing to the next level and follow our free weekly MoneyFlows insights. Related Articles AI Agent Security Boosts Okta SharesUS Indices Forecast: Bullish Momentum Targets Record BreakoutsWith Dropping Rates, Will We See Risk Appetite Return?About the Author Lucas is a well-versed equity investor and educator. He currently is co-founder of research and analytics firm, MAPsignals.com, which focuses on finding outlier stocks by following the Big Money. Editors’ Picks |
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2026-07-10 18:15
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2026-07-10 13:46
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3 Reasons Why Growth Investors Shouldn't Overlook Neurocrine (NBIX) | FMP Stock News | |
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Investors seek growth stocks to capitalize on above-average growth in financials that help these securities grab the market's attention and produce exceptional returns. But finding a great growth stock is not easy at all.That's because, these stocks usually carry above-average risk and volatility. In fact, betting on a stock for which the growth story is actually over or nearing its end could lead to significant loss. However, the task of finding cutting-edge growth stocks is made easy with the help of the Zacks Growth Style Score (part of the Zacks Style Scores system), which looks beyond the traditional growth attributes to analyze a company's real growth prospects. Neurocrine Biosciences (NBIX - Free Report) is one such stock that our proprietary system currently recommends. The company not only has a favorable Growth Score, but also carries a top Zacks Rank. Research shows that stocks carrying the best growth features consistently beat the market. And returns are even better for stocks that possess the combination of a Growth Score of A or B and a Zacks Rank #1 (Strong Buy) or 2 (Buy). While there are numerous reasons why the stock of this biopharmaceutical company is a great growth pick right now, we have highlighted three of the most important factors below: Earnings GrowthEarnings growth is arguably the most important factor, as stocks exhibiting exceptionally surging profit levels tend to attract the attention of most investors. For growth investors, double-digit earnings growth is highly preferable, as it is often perceived as an indication of strong prospects (and stock price gains) for the company under consideration. While the historical EPS growth rate for Neurocrine is 44%, investors should actually focus on the projected growth. The company's EPS is expected to grow 48.3% this year, crushing the industry average, which calls for EPS growth of 14.4%. Impressive Asset Utilization RatioAsset utilization ratio -- also known as sales-to-total-assets (S/TA) ratio -- is often overlooked by investors, but it is an important indicator in growth investing. This metric shows how efficiently a firm is utilizing its assets to generate sales. Right now, Neurocrine has an S/TA ratio of 0.7, which means that the company gets $0.7 in sales for each dollar in assets. Comparing this to the industry average of 0.48, it can be said that the company is more efficient. In addition to efficiency in generating sales, sales growth plays an important role. And Neurocrine looks attractive from a sales growth perspective as well. The company's sales are expected to grow 31.1% this year versus the industry average of 0%. Promising Earnings Estimate RevisionsSuperiority of a stock in terms of the metrics outlined above can be further validated by looking at the trend in earnings estimate revisions. A positive trend is of course favorable here. Empirical research shows that there is a strong correlation between trends in earnings estimate revisions and near-term stock price movements. There have been upward revisions in current-year earnings estimates for Neurocrine. The Zacks Consensus Estimate for the current year has surged 5% over the past month. Bottom LineWhile the overall earnings estimate revisions have made Neurocrine a Zacks Rank #1 stock, it has earned itself a Growth Score of B based on a number of factors, including the ones discussed above. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. This combination positions Neurocrine well for outperformance, so growth investors may want to bet on it. |
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2026-07-09 20:40
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2026-07-09 16:01
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Neurocrine Biosciences Announces Conference Call and Webcast of Second Quarter 2026 Financial Results | FMP Stock News | |
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Conference Call and Webcast Scheduled for Thursday, July 30, /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that it has scheduled its second quarter 2026 financial results conference call and webcast for 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) on July 30, 2026. The schedule for the press release and conference call / webcast is as follows: Q2 2026 Press Release: July 30, 2026 at 1:00 p.m. PT / 4:00 p.m. ET Q2 2026 Conference Call: July 30, 2026 at 1:30 p.m. PT / 4:30 p.m. ET Domestic Dial-In Number: 800-347-6865 International Dial-In Number: 203-518-9757 Conference ID: NBIX The webcast can also be accessed on Neurocrine Biosciences' website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month. About Neurocrine Biosciences Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. SOURCE Neurocrine Biosciences, Inc. |
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2026-07-08 18:17
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2026-07-08 13:01
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Neurocrine (NBIX) Upgraded to Strong Buy: What Does It Mean for the Stock? | FMP Stock News | |
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Neurocrine Biosciences (NBIX - Free Report) could be a solid choice for investors given its recent upgrade to a Zacks Rank #1 (Strong Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years. The power of a changing earnings picture in determining near-term stock price movements makes the Zacks rating system highly useful for individual investors, since it can be difficult to make decisions based on rating upgrades by Wall Street analysts. These are mostly driven by subjective factors that are hard to see and measure in real time. As such, the Zacks rating upgrade for Neurocrine is essentially a positive comment on its earnings outlook that could have a favorable impact on its stock price. Most Powerful Force Impacting Stock PricesThe change in a company's future earnings potential, as reflected in earnings estimate revisions, and the near-term price movement of its stock are proven to be strongly correlated. That's partly because of the influence of institutional investors that use earnings and earnings estimates for calculating the fair value of a company's shares. An increase or decrease in earnings estimates in their valuation models simply results in higher or lower fair value for a stock, and institutional investors typically buy or sell it. Their bulk investment action then leads to price movement for the stock. For Neurocrine, rising earnings estimates and the consequent rating upgrade fundamentally mean an improvement in the company's underlying business. And investors' appreciation of this improving business trend should push the stock higher. Harnessing the Power of Earnings Estimate RevisionsAs empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock movements, tracking such revisions for making an investment decision could be truly rewarding. Here is where the tried-and-tested Zacks Rank stock-rating system plays an important role, as it effectively harnesses the power of earnings estimate revisions. The Zacks Rank stock-rating system, which uses four factors related to earnings estimates to classify stocks into five groups, ranging from Zacks Rank #1 (Strong Buy) to Zacks Rank #5 (Strong Sell), has an impressive externally-audited track record, with Zacks Rank #1 stocks generating an average annual return of +25% since 1988. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here >>>> . Earnings Estimate Revisions for NeurocrineFor the fiscal year ending December 2026, this biopharmaceutical company is expected to earn $9.47 per share, which is unchanged compared with the year-ago reported number. Analysts have been steadily raising their estimates for Neurocrine. Over the past three months, the Zacks Consensus Estimate for the company has increased 20.7%. Bottom LineUnlike the overly optimistic Wall Street analysts whose rating systems tend to be weighted toward favorable recommendations, the Zacks rating system maintains an equal proportion of "buy" and "sell" ratings for its entire universe of more than 4,000 stocks at any point in time. Irrespective of market conditions, only the top 5% of the Zacks-covered stocks get a "Strong Buy" rating and the next 15% get a "Buy" rating. So, the placement of a stock in the top 20% of the Zacks-covered stocks indicates its superior earnings estimate revision feature, making it a solid candidate for producing market-beating returns in the near term. You can learn more about the Zacks Rank here >>> The upgrade of Neurocrine to a Zacks Rank #1 positions it in the top 5% of the Zacks-covered stocks in terms of estimate revisions, implying that the stock might move higher in the near term. |
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2026-07-06 15:58
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2026-07-06 11:45
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Reasons Why Investors Should Consider Betting on Neurocrine Stock | FMP Stock News | |
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Key Takeaways NBIX is driving growth with rising Ingrezza sales, increasing Crenessity uptake & reaffirmed 2026 guidance. NBIX advanced its late-stage and early-stage programs across schizophrenia, TD and obesity. Neurocrine added Vykat XR through the Soleno acquisition, expanding its commercial rare disease portfolio. Neurocrine Biosciences (NBIX - Free Report) continues to strengthen its growth profile through the solid commercial performance of its marketed therapies, a steadily advancing late-stage neuroscience pipeline and strategic business development initiatives.Strong Commercial Performance Aids NBIX’s GrowthNeurocrine is making steady progress, with strong commercial performance from its two marketed drugs, Ingrezza and Crenessity (crinecerfont). Ingrezza, the first FDA-approved VMAT2 inhibitor for tardive dyskinesia (TD), has remained the company's flagship product since its launch in 2017. The therapy established market leadership in TD and expanded its commercial opportunity with its approval for the treatment of Huntington's disease chorea in 2023. In the first quarter of 2026, the drug generated net product sales of $656.9 million, up 20% year over year, driven by double-digit prescription growth and record new patient starts. Management reaffirmed its full-year 2026 Ingrezza sales guidance of $2.7-$2.8 billion, highlighting continued confidence in the product's growth trajectory. Neurocrine's second commercial product, Crenessity (crinecerfont), is also emerging as an important growth contributor. In December 2024, the FDA approved Crenessity as an adjunctive treatment to glucocorticoid replacement therapy to control androgen levels in adult and pediatric patients aged four years and older with classic congenital adrenal hyperplasia (CAH). Since its launch, the drug has delivered consistent quarter-over-quarter commercial growth, supported by robust physician adoption, increasing patient demand and expanding reimbursement coverage. Year to date, shares of NBIX have risen 22.9% against the industry’s 2.9% decline. Image Source: Zacks Investment Research Robust Pipeline Supports NBIX’s Long-Term Growth OutlookBeyond its marketed products, Neurocrine continues to strengthen its long-term growth outlook through a robust and diversified neuroscience pipeline spanning multiple high-value indications. The company's lead late-stage candidate, direclidine (NBI-1117568), is in phase III development for schizophrenia while also being evaluated in a mid-stage study for bipolar mania. Another promising late-stage asset, osavampator (NBI-1065845), is being developed for major depressive disorder with cognitive impairment, a condition with substantial unmet medical need. Neurocrine is also expanding the commercial opportunity for Crenessity through additional clinical development. The company initiated a phase II study this month to assess the safety and tolerability of Crenessity in pediatric patients younger than four years with classic CAH and completed target enrollment in a separate European Union phase II study involving children from birth to under two years of age. Successful development in these younger patient populations could further broaden the drug's addressable market. The company has continued to advance its early-stage pipeline. During the year, Neurocrine initiated phase II studies evaluating NBI-1117570 for schizophrenia and NBI-1065890, a next-generation VMAT2 inhibitor for tardive dyskinesia. It also started a first-in-human phase I study of NBIP-2118, a first-in-class therapy for obesity. These pipeline advancements strengthen Neurocrine's prospects for sustained innovation and long-term revenue growth across the neuroscience and rare disease markets. Soleno Acquisition Strengthens NBIX's Commercial PortfolioThe company enhanced its long-term growth strategy through the acquisition of Soleno Therapeutics in May. The acquisition added Soleno’s Vykat XR (diazoxide choline), a first-in-class treatment for hyperphagia associated with Prader-Willi syndrome (PWS), to Neurocrine’s commercial portfolio. It is the first and only FDA-approved therapy for hyperphagia in adults and pediatric patients four years of age and older with PWS. Backed by a robust intellectual property portfolio extending into the mid-2040s, the therapy offers a sustainable platform for long-term value creation. NBIX's Zacks Rank & EstimatesNeurocrine currently sports a Zacks Rank #1 (Strong Buy). Over the past 60 days, earnings per share estimates for Neurocrine have risen from $8.04 to $9.47 for 2026 and from $9.54 to $10.79 for 2027. Other Stocks to ConsiderSome other top-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) , Amarin Corporation (AMRN - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss per share of 88 cents to earnings of 6 cents per share. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 6.3% year to date. Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 46.66%. Over the past 60 days, loss per share estimates for Amarin have narrowed from $15.20 to 65 cents for 2026. Over the same period, estimates for loss per share have also narrowed from $13.00 to 51 cents for 2027. AMRN shares have risen 17.3% year to date. Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.92 from $2.91. LQDA shares have surged 128.9% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%. |
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2026-07-02 20:56
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2026-07-02 14:55
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Neurocrine Biosciences: Why I Am Upholding A Buy Rating After M&A Deal For Soleno | FMP Stock News | |
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Neurocrine Biosciences, Inc. remains a Buy, driven by robust growth from Ingrezza, Crenessity, and the recent Vykat acquisition. Q1 2026 revenues rose 44% year-on-year to $811m, with Ingrezza and Crenessity annualizing at blockbuster levels and Vykat showing rapid ramp-up. NBIX stock valuation reflects high-growth expectations; forward P/S ~5.1x and P/E ~30x, justified by an expanding commercial portfolio and pipeline catalysts. |
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2026-07-01 21:00
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2026-07-01 16:05
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Neurocrine Biosciences Initiates Phase 2 Study of Crinecerfont in Pediatric Patients Under 4 Years Old with Classic Congenital Adrenal Hyperplasia | FMP Stock News | |
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, /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of its Phase 2 clinical study to assess the safety and tolerability of crinecerfont in children aged 3 months to under 4 years with classic congenital adrenal hyperplasia (CAH). Crinecerfont, marketed as CRENESSITY®, is approved in the United States as an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients 4 years of age and older with classic CAH."Infants and young children with classic CAH face significant health challenges and are often exposed to high doses of glucocorticoids during critical periods of growth and development," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "The initiation of this Phase 2 study reflects our commitment to evaluating crinecerfont as a potential treatment option that could reduce the need for long-term supraphysiologic glucocorticoid use and help mitigate the associated risks in this vulnerable, very young population." CAH is typically identified at or shortly after birth and can lead to life-threatening adrenal crises due to the underlying adrenal insufficiency, as well as androgen excess and consistent dosing of supraphysiologic glucocorticoids – complications for which there are no approved therapies in children under 4 years of age. Neurocrine is conducting this pediatric study under an FDA Pediatric Written Request. The Phase 2 open-label, single-arm study consists of a 24-week treatment period with a primary objective of assessing the safety and tolerability of crinecerfont in 20 participants aged 3 months to under 4 years with classic CAH. Secondary objectives include evaluation of the pharmacokinetics and pharmacodynamic effects of crinecerfont on hormone biomarkers. This study is expected to support a planned supplemental New Drug Application to expand the approved U.S. indication to include patients less than 4 years of age. Additional information about the trial, including eligibility criteria, can be found at ClinicalTrials.gov. Separately, Neurocrine achieved target enrollment for a Phase 2 study in the European Union to evaluate the safety and tolerability of crinecerfont in children from birth to under 2 years of age with classic CAH. For more information, visit ClinicalTrials.gov. Crinecerfont was approved by the U.S. Food and Drug Administration in 2024, marking the first therapeutic advancement in more than 70 years for patients with classic CAH. It is a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist that reduces elevated adrenocorticotropic hormone (ACTH) secretion at the source and the resulting downstream excess adrenal androgens through a non-GC mechanism. About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is a rare genetic condition that results in an enzyme deficiency that alters the production of adrenal steroid hormones, such as cortisol, aldosterone and adrenal androgens. Severe enzyme deficiency leads to an inability of the adrenal glands to produce enough cortisol and, in approximately 75% of cases, aldosterone. Because individuals with CAH are typically still able to produce androgens, the unused precursors that would normally be used to make cortisol instead result in the production of excess amounts of androgens. If left untreated, CAH can result in adrenal crisis and even death. Exogenous glucocorticoids (GCs) are necessary to correct the endogenous cortisol deficiency, but historically, doses higher than those needed for cortisol replacement (supraphysiologic) have been used to lower the elevated levels of adrenocorticotropic hormone (ACTH) and adrenal androgens. However, GC treatment at supraphysiologic doses has been associated with serious and significant complications of steroid excess, including metabolic issues such as weight gain and diabetes, cardiovascular disease and osteoporosis. Additionally, long-term treatment with supraphysiologic GCs may have psychological and cognitive impacts, such as changes in mood and memory. Adrenal androgen excess has been associated with abnormal bone growth and development in pediatric patients, female health problems such as excess facial hair growth and menstrual irregularities, in addition to cardiometabolic and fertility issues in both sexes. The symptoms of high ACTH may include testicular adrenal rest tumors (TARTs). About CRENESSITY® (crinecerfont) CRENESSITY is a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist that reduces and controls excess adrenocorticotropic hormone (ACTH) and adrenal androgens through a non-glucocorticoid (GC) mechanism for the treatment of classic congenital adrenal hyperplasia (CAH). Antagonism of CRF1 receptors in the pituitary has been shown to decrease ACTH levels, which in turn decreases the production of adrenal androgens and potentially the symptoms associated with CAH. The robust clinical study data demonstrate that lowering adrenal androgen levels with CRENESSITY enables lower, more physiologic dosing of GCs to replace missing cortisol. CRENESSITY comes in capsules and an oral solution. For adults 18 years of age and older, the recommended dosage is 100 mg twice daily taken orally with a meal. For pediatric patients 4 to 17 years of age weighing less than 55 kg (121 lbs), the recommended dosage is based on body weight and is administered twice daily, taken orally with a meal. For pediatric patients weighing more than 55 kg (121 lbs), the recommended dosage is 100 mg twice daily taken orally with a meal. Healthcare providers can work with patients to determine the appropriate formulation for use depending on patient needs. Patients receiving CRENESSITY should continue GC therapy for cortisol replacement. Important Information Approved Uses CRENESSITY® (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH). IMPORTANT SAFETY INFORMATION Do not take CRENESSITY if you: Are allergic to crinecerfont, or any of the ingredients in CRENESSITY. CRENESSITY may cause serious side effects, including: Allergic reactions. Symptoms of an allergic reaction include tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash. If you have an allergic reaction to CRENESSITY, get emergency medical help right away and stop taking CRENESSITY. Risk of Sudden Adrenal Insufficiency or Adrenal Crisis with Too Little Glucocorticoid (Steroid) Medicine. Sudden adrenal insufficiency or adrenal crisis can happen in people with congenital adrenal hyperplasia who are not taking enough glucocorticoid (steroid) medicine. You should continue taking your glucocorticoid (steroid) medicine during treatment with CRENESSITY. Certain conditions such as infection, severe injury, or shock may increase your risk for sudden adrenal insufficiency or adrenal crisis. Tell your healthcare provider if you get a severe injury, infection, illness, or have planned surgery during treatment. Your healthcare provider may need to change your dose of glucocorticoid (steroid) medicine. Before taking CRENESSITY, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. The most common side effects of CRENESSITY in adults include tiredness, headache, dizziness, joint pain, back pain, decreased appetite, and muscle pain. The most common side effects of CRENESSITY in children include headache, stomach pain, tiredness, nasal congestion, and nosebleeds. These are not all the possible side effects of CRENESSITY. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. Dosage Forms and Strengths: CRENESSITY is available in 50 mg and 100 mg capsules, and as an oral solution of 50 mg/mL. Please see full Prescribing Information. About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, YOU DESERVE BRAVE SCIENCE and CRENESSITY are registered trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding our future development plans with respect to crinecerfont; the efficacy and therapeutic potential of crinecerfont in children aged 3 months to under 4 years with classic congenital adrenal hyperplasia (CAH); and the value and benefits CRENESSITY brings to adults and pediatric patients 4 years of age and older with CAH. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that regulatory submissions for our product candidates may not occur or be submitted in a timely manner; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with U.S. federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse impact on our revenues or potential revenue; risks associated with potential generic entrants for our products; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2026 Neurocrine Biosciences, Inc. All Rights Reserved. SOURCE Neurocrine Biosciences, Inc. |
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2026-07-01 18:36
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2026-07-01 13:01
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Neurocrine Biosciences (NBIX) Is Up 6.46% in One Week: What You Should Know | FMP Stock News | |
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Momentum investing is all about the idea of following a stock's recent trend, which can be in either direction. In the "long context," investors will essentially be "buying high, but hoping to sell even higher." And for investors following this methodology, taking advantage of trends in a stock's price is key; once a stock establishes a course, it is more than likely to continue moving in that direction. The goal is that once a stock heads down a fixed path, it will lead to timely and profitable trades.Even though momentum is a popular stock characteristic, it can be tough to define. Debate surrounding which are the best and worst metrics to focus on is lengthy, but the Zacks Momentum Style Score, part of the Zacks Style Scores, helps address this issue for us. Below, we take a look at Neurocrine Biosciences (NBIX - Free Report) , which currently has a Momentum Style Score of A. We also discuss some of the main drivers of the Momentum Style Score, like price change and earnings estimate revisions. It's also important to note that Style Scores work as a complement to the Zacks Rank, our stock rating system that has an impressive track record of outperformance. Neurocrine Biosciences currently has a Zacks Rank of #1 (Strong Buy). Our research shows that stocks rated Zacks Rank #1 (Strong Buy) and #2 (Buy) and Style Scores of "A or B" outperform the market over the following one-month period. You can see the current list of Zacks #1 Rank Stocks here >>> Set to Beat the Market? In order to see if NBIX is a promising momentum pick, let's examine some Momentum Style elements to see if this biopharmaceutical company holds up. Looking at a stock's short-term price activity is a great way to gauge if it has momentum, since this can reflect both the current interest in a stock and if buyers or sellers have the upper hand at the moment. It is also useful to compare a security to its industry, as this can help investors pinpoint the top companies in a particular area. For NBIX, shares are up 6.46% over the past week while the Zacks Medical - Drugs industry is up 0.55% over the same time period. Shares are looking quite well from a longer time frame too, as the monthly price change of 8.84% compares favorably with the industry's 0.36% performance as well. While any stock can see a spike in price, it takes a real winner to consistently outperform the market. Over the past quarter, shares of Neurocrine Biosciences have risen 28.75%, and are up 31.67% in the last year. In comparison, the S&P 500 has only moved 14.95% and 21.93%, respectively. Investors should also pay attention to NBIX's average 20-day trading volume. Volume is a useful item in many ways, and the 20-day average establishes a good price-to-volume baseline; a rising stock with above average volume is generally a bullish sign, whereas a declining stock on above average volume is typically bearish. NBIX is currently averaging 1,182,979 shares for the last 20 days. Earnings OutlookThe Zacks Momentum Style Score encompasses many things, including estimate revisions and a stock's price movement. Investors should note that earnings estimates are also significant to the Zacks Rank, and a nice path here can be promising. We have recently been noticing this with NBIX. Over the past two months, 7 earnings estimates moved higher compared to none lower for the full year. These revisions helped boost NBIX's consensus estimate, increasing from $8.04 to $9.47 in the past 60 days. Looking at the next fiscal year, 6 estimates have moved upwards while there have been no downward revisions in the same time period. Bottom LineGiven these factors, it shouldn't be surprising that NBIX is a #1 (Strong Buy) stock and boasts a Momentum Score of A. If you're looking for a fresh pick that's set to soar in the near-term, make sure to keep Neurocrine Biosciences on your short list. |
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2026-06-24 18:38
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2026-06-24 13:45
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Is Neurocrine (NBIX) a Solid Growth Stock? 3 Reasons to Think "Yes" | FMP Stock News | |
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Growth stocks are attractive to many investors, as above-average financial growth helps these stocks easily grab the market's attention and produce exceptional returns. But finding a great growth stock is not easy at all.By their very nature, these stocks carry above-average risk and volatility. Moreover, if a company's growth story is over or nearing its end, betting on it could lead to significant loss. However, it's pretty easy to find cutting-edge growth stocks with the help of the Zacks Growth Style Score (part of the Zacks Style Scores system), which looks beyond the traditional growth attributes to analyze a company's real growth prospects. Neurocrine Biosciences (NBIX - Free Report) is one such stock that our proprietary system currently recommends. The company not only has a favorable Growth Score, but also carries a top Zacks Rank. Research shows that stocks carrying the best growth features consistently beat the market. And for stocks that have a combination of a Growth Score of A or B and a Zacks Rank #1 (Strong Buy) or 2 (Buy), returns are even better. Here are three of the most important factors that make the stock of this biopharmaceutical company a great growth pick right now. Earnings GrowthEarnings growth is arguably the most important factor, as stocks exhibiting exceptionally surging profit levels tend to attract the attention of most investors. And for growth investors, double-digit earnings growth is definitely preferable, and often an indication of strong prospects (and stock price gains) for the company under consideration. While the historical EPS growth rate for Neurocrine is 44%, investors should actually focus on the projected growth. The company's EPS is expected to grow 48.3% this year, crushing the industry average, which calls for EPS growth of 17.3%. Impressive Asset Utilization RatioGrowth investors often overlook asset utilization ratio, also known as sales-to-total-assets (S/TA) ratio, but it is an important feature of a real growth stock. This metric exhibits how efficiently a firm is utilizing its assets to generate sales. Right now, Neurocrine has an S/TA ratio of 0.7, which means that the company gets $0.7 in sales for each dollar in assets. Comparing this to the industry average of 0.48, it can be said that the company is more efficient. In addition to efficiency in generating sales, sales growth plays an important role. And Neurocrine looks attractive from a sales growth perspective as well. The company's sales are expected to grow 31.1% this year versus the industry average of 0%. Promising Earnings Estimate RevisionsSuperiority of a stock in terms of the metrics outlined above can be further validated by looking at the trend in earnings estimate revisions. A positive trend is of course favorable here. Empirical research shows that there is a strong correlation between trends in earnings estimate revisions and near-term stock price movements. There have been upward revisions in current-year earnings estimates for Neurocrine. The Zacks Consensus Estimate for the current year has surged 5% over the past month. Bottom LineWhile the overall earnings estimate revisions have made Neurocrine a Zacks Rank #1 stock, it has earned itself a Growth Score of B based on a number of factors, including the ones discussed above. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. This combination positions Neurocrine well for outperformance, so growth investors may want to bet on it. |
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2026-06-24 16:13
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2026-06-24 04:36
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Best Value Stocks to Buy for June 24th | FMP Stock News | |
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Here are three stocks with buy rank and strong value characteristics for investors to consider today, June 24:Navigator Holdings Ltd. (NVGS - Free Report) : This global operator of a fleet of liquefied gas carriers carries a Zacks Rank #1, and has witnessed the Zacks Consensus Estimate for its current year earnings increasing 29.5% over the last 60 days. Navigator has a price-to-earnings ratio (P/E) of 10.84, compared with 22.97 for the S&P 500. The company possesses a Value Score of B. Byline Bancorp, Inc. (BY - Free Report) : This bank holding company for Byline Bank carries a Zacks Rank #1, and has witnessed the Zacks Consensus Estimate for its current year earnings increasing 6.2% over the last 60 days. Byline has a price-to-earnings ratio (P/E) of 10.82, compared with 22.97 for the S&P 500. The company possesses a Value Score of B. Neurocrine Biosciences, Inc. (NBIX - Free Report) : This developer of innovative therapies for neurological and endocrine disorders carries a Zacks Rank #1, and has witnessed the Zacks Consensus Estimate for its current year earnings increasing 14.4% over the last 60 days. Neurocrine has a price-to-earnings ratio (P/E) of 17.67, compared with 22.97 for the S&P 500. The company possesses a Value Score of B. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Learn more about the Value score and how it is calculated here. |
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2026-06-24 16:13
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2026-06-24 05:06
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New Strong Buy Stocks for June 24th | FMP Stock News | |
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Here are five stocks added to the Zacks Rank #1 (Strong Buy) List today:Byline Bancorp, Inc. (BY - Free Report) : This bank holding company for Byline Bank has seen the Zacks Consensus Estimate for its current year earnings increasing 6.2% over the last 60 days. Navigator Holdings Ltd. (NVGS - Free Report) : This global operator of a fleet of liquefied gas carriers has seen the Zacks Consensus Estimate for its current year earnings increasing 29.5% over the last 60 days. Neurocrine Biosciences, Inc. (NBIX - Free Report) : This developer of innovative therapies for neurological and endocrine disorders has seen the Zacks Consensus Estimate for its current year earnings increasing 14.4% over the last 60 days. TFI International Inc. (TFII - Free Report) : This transportation and logistics company has seen the Zacks Consensus Estimate for its current year earnings increasing 12.6% over the last 60 days. Bunge Global SA (BG - Free Report) : This agricultural and food company has seen the Zacks Consensus Estimate for its current year earnings increasing 12.3% over the last 60 days. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. |
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2026-06-15 20:34
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2026-06-15 16:05
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Neurocrine Biosciences Presents First Retrospective Case Series of CRENESSITY® (crinecerfont) in Patients with Classic Congenital Adrenal Hyperplasia Due to 11β‑Hydroxylase Deficiency at ENDO 2026 | FMP Stock News | |
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Androstenedione and other adrenal hormone levels in 11β‑hydroxylase-deficient patients improved substantially after initiation of CRENESSITY, with >90% median reductions in 11-deoxycortisol and 11-deoxycorticosterone Nearly all patients (14/15) reduced their total glucocorticoid dose with CRENESSITY, and 2 of 5 patients on antihypertensive medications reduced or discontinued these drugs Findings provide initial clinical insights in patients with classic congenital adrenal hyperplasia due to 11β-hydroxylase deficiency, a rare subtype not previously studied in clinical trials of CRENESSITY , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced clinical findings from the first retrospective case series in pediatric and adult patients with classic congenital adrenal hyperplasia (CAH) due to 11β‑hydroxylase deficiency. This subtype was not previously studied in clinical trials of CRENESSITY® (crinecerfont) and is the second most common form of classic CAH after 21-hydroxylase deficiency, accounting for approximately 5% of cases. The findings were presented at the Endocrine Society's annual meeting, ENDO 2026, in Chicago.Like other forms of CAH, 11β‑hydroxylase deficiency (11β‑OHD) is characterized by cortisol deficiency and excess adrenal androgens. However, 11β‑OHD is uniquely associated with the accumulation of the adrenal steroid precursors 11-deoxycortisol (11-dF) and 11-deoxycorticosterone (DOC). These hormonal imbalances can contribute to distinct clinical features, including hypertension and other long‑term complications. In this retrospective case series, reductions in androstenedione (A4) were observed across all patients with elevated baseline levels following initiation of CRENESSITY. Steroid precursors also decreased, with values reaching within normal ranges, and blood pressure improved in adult patients. "Patients with 11β‑hydroxylase deficiency represent a complex subgroup within classic congenital adrenal hyperplasia, with limited data available to guide treatment decisions for these individuals," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "This first case series provides preliminary clinical insights on the use of CRENESSITY to target ACTH and potentially improve hormonal control in patients with 11β‑hydroxylase deficiency, highlighting our ongoing commitment to advancing care for the entire classic CAH community." This retrospective case series outlines clinical responses to CRENESSITY treatment in 15 pediatric (n=11) and adult (n=4) patients with classic CAH due to 11β‑OHD. Across all patients with elevated A4 and/or adrenal steroid precursors at baseline, initiation of CRENESSITY was associated with reduction of levels. A4 and precursor normalization were observed as early as one month following treatment initiation, including in patients whose hormone excess had persisted despite prior supraphysiologic glucocorticoid (GC) therapy. Among patients with elevated hormones at baseline, median decreases of -92% (DOC, n=5), -95% (11‑dF, n=7), and -65% (A4, n=3) were observed after CRENESSITY initiation. Among patients receiving antihypertensive treatment, two of five were able to reduce or discontinue these medications. Following the initiation of CRENESSITY, 14 of 15 patients were able to reduce their total GC dose. "Patients with 11β-hydroxylase deficiency often experience both androgen excess and elevated adrenal steroid precursors that can contribute to hypertension and other complications, making disease management particularly challenging," said Kyriakie Sarafoglou, M.D., Professor, Department of Pediatrics and Department of Experimental and Clinical Pharmacology, Divisions of Endocrinology and Genetics & Metabolism, University of Minnesota. "Given the rarity of this condition, data from 15 patients gives clinicians meaningful insight into the potential role of CRENESSITY in managing this challenging form of classic congenital adrenal hyperplasia." This case series provides early, foundational evidence supporting the efficacy and safety of CRENESSITY treatment in patients with classic CAH due to 11β-OHD. Although CRENESSITY is approved as an adjunctive treatment to GCs for patients with classic CAH regardless of enzyme deficiency, there is limited evidence on its use in this rare subtype. These findings support further exploration of CRENESSITY in this classic CAH subtype and reinforce Neurocrine's commitment to supporting patients across the full spectrum of classic CAH and other rare endocrine diseases. Presentations at the ENDO 2026 annual meeting included: CAHtalyst® Adult Study Two-Year Results Title: Weight-Related Outcomes and Insulin Resistance in Adults with Classic Congenital Adrenal Hyperplasia: 2-Year Results from the CAHtalyst Adult Study (Oral Presentation #ORF32-07) Authors: Oksana Hamidi, D.O., et al Title: Adults with Classic Congenital Adrenal Hyperplasia Taking Crinecerfont Demonstrated Sustained Decreases in Glucocorticoid Doses: 2-Year Results from the CAHtalyst Adult Study (Poster Presentation #SUN-458) Authors: Irina Bancos, M.D., et al Title: A Cross-sectional Survey on Quality of Life of Adults with Classic Congenital Adrenal Hyperplasia in the United States Participating in CAHtalyst Adult Open-Label Extension Study (Poster Presentation #SUN-467) Authors: Sonal Vaid, M.D., et al Title: Bone Outcomes in Adults with Classic Congenital Adrenal Hyperplasia Treated with Crinecerfont for Up to 2 Years in CAHtalyst Adult Study (Poster Presentation #SUN-468) Authors: Maria Vogiatzi, M.D., et al CAHtalyst Pediatric Study Two-Year Results Title: Characterization of Children and Adolescents with Classic Congenital Adrenal Hyperplasia Who Had Slowed Bone Age Progression and Improved Height Prediction with Crinecerfont (Oral Presentation #ORF32-05) Authors: Maria Vogiatzi, M.D., et al Title: Long-term Crinecerfont Treatment Reduced ACTH and 17-Hydroxyprogesterone — Clinical Outcomes in Children and Adolescents with Classic Congenital Adrenal Hyperplasia: 2-Year Results from CAHtalyst Pediatric (Poster Presentation #SAT-465) Authors: Natalie Nokoff, M.D., et al Title: Long-term Crinecerfont Enables Sustained Decreases in Glucocorticoid Doses — Clinical Outcomes in Children and Adolescents with Classic Congenital Adrenal Hyperplasia: 2-Year Results from CAHtalyst Pediatric (Poster Presentation #SUN-465) Authors: Kyriakie Sarafoglou, M.D., et al Additional Presentations Title: Long-Term Risk of Cardiometabolic Comorbidities Associated with Glucocorticoid Exposure and Androgen Control in Classic Congenital Adrenal Hyperplasia: A Cox Proportional Hazards Analysis from the CAHtalog Registry ("New Therapies and Perspectives for Congenital Adrenal Hyperplasia and Adrenal Insufficiency" Rapid Fire Presentation #ORF32-02 and Poster Presentation #MON-495) Authors: Oksana Lekarev, D.O., et al Title: Crinecerfont Treatment of Classic Congenital Adrenal Hyperplasia Due to 11β-Hydroxylase Deficiency: A Case Series (Poster Presentation #SAT-466) Authors: Kyriakie Sarafoglou, M.D., et al Title: A Modified Delphi Panel of U.S. Endocrinologists to Align on Minimum Clinically Important Difference in Glucocorticoid Dose and Other Key Considerations in Classic Congenital Adrenal Hyperplasia (Poster Presentation #SAT-459) Authors: Ahmed Khattab, M.D., et al About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is a rare genetic condition that results in an enzyme deficiency that alters the production of adrenal steroid hormones, such as cortisol, aldosterone and adrenal androgens. Severe enzyme deficiency leads to an inability of the adrenal glands to produce enough cortisol and, in approximately 75% of cases, aldosterone. Because individuals with CAH are typically still able to produce androgens, the unused precursors that would normally be used to make cortisol instead result in the production of excess amounts of androgens. If left untreated, CAH can result in adrenal crisis and even death. Exogenous glucocorticoids (GCs) are necessary to correct the endogenous cortisol deficiency, but historically, doses higher than those needed for cortisol replacement (supraphysiologic) have been used to lower the elevated levels of adrenocorticotropic hormone (ACTH) and adrenal androgens. However, GC treatment at supraphysiologic doses has been associated with serious and significant complications of steroid excess, including metabolic issues such as weight gain and diabetes, cardiovascular disease and osteoporosis. Additionally, long-term treatment with supraphysiologic GCs may have psychological and cognitive impacts, such as changes in mood and memory. Adrenal androgen excess has been associated with abnormal bone growth and development in pediatric patients, female health problems such as excess facial hair growth and menstrual irregularities, in addition to cardiometabolic and fertility issues in both sexes. The symptoms of high ACTH may include testicular adrenal rest tumors (TARTs). About CRENESSITY® (crinecerfont) CRENESSITY is a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist that reduces and controls excess adrenocorticotropic hormone (ACTH) and adrenal androgens through a non-glucocorticoid (GC) mechanism for the treatment of classic congenital adrenal hyperplasia (CAH). Antagonism of CRF1 receptors in the pituitary has been shown to decrease ACTH levels, which in turn decreases the production of adrenal androgens and potentially the symptoms associated with CAH. The robust clinical study data demonstrate that lowering adrenal androgen levels with CRENESSITY enables lower, more physiologic dosing of GCs to replace missing cortisol. CRENESSITY comes in capsules and an oral solution. For adults 18 years of age and older, the recommended dosage is 100 mg twice daily taken orally with a meal. For pediatric patients four to 17 years of age weighing less than 55 kg (121 lbs), the recommended dosage is based on body weight and is administered twice daily, taken orally with a meal. For pediatric patients weighing more than 55 kg (121 lbs), the recommended dosage is 100 mg twice daily taken orally with a meal. Healthcare providers can work with patients to determine the appropriate formulation for use depending on patient needs. Patients receiving CRENESSITY should continue GC therapy for cortisol replacement. About the CAHtalyst® Studies The Phase 3 CAHtalyst global registrational studies were designed to evaluate the safety, efficacy and tolerability of CRENESSITY® (crinecerfont) in children and adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The CAHtalyst studies were the largest-ever clinical trial program in classic CAH, including 285 pediatric and adult patients. The CAHtalyst Pediatric study included 103 pediatric patients four to 17 years of age. The study tested two questions. The first question evaluated whether four weeks of CRENESSITY treatment could improve androgen control. The second question evaluated whether an additional 24 weeks of CRENESSITY treatment enabled customized glucocorticoid (GC) down-titration while androstenedione levels were maintained or improved. The CAHtalyst Adult study included 182 adult patients 18 to 58 years of age. Similarly, the first question of the study evaluated whether four weeks of CRENESSITY treatment could improve androgen control, and the second question evaluated whether an additional 20 weeks of CRENESSITY treatment enabled GC reduction to physiologic range while androstenedione levels were maintained or improved. Data from the CAHtalyst Phase 3 studies supported approval of CRENESSITY by the U.S. Food and Drug Administration in December 2024. The open-label extension treatment portions of both studies are ongoing. Important Information Approved Uses CRENESSITY® (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH). IMPORTANT SAFETY INFORMATION Do not take CRENESSITY if you: Are allergic to crinecerfont, or any of the ingredients in CRENESSITY. CRENESSITY may cause serious side effects, including: Allergic reactions. Symptoms of an allergic reaction include tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash. If you have an allergic reaction to CRENESSITY, get emergency medical help right away and stop taking CRENESSITY. Risk of Sudden Adrenal Insufficiency or Adrenal Crisis with Too Little Glucocorticoid (Steroid) Medicine. Sudden adrenal insufficiency or adrenal crisis can happen in people with congenital adrenal hyperplasia who are not taking enough glucocorticoid (steroid) medicine. You should continue taking your glucocorticoid (steroid) medicine during treatment with CRENESSITY. Certain conditions such as infection, severe injury, or shock may increase your risk for sudden adrenal insufficiency or adrenal crisis. Tell your healthcare provider if you get a severe injury, infection, illness, or have planned surgery during treatment. Your healthcare provider may need to change your dose of glucocorticoid (steroid) medicine. Before taking CRENESSITY, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. The most common side effects of CRENESSITY in adults include tiredness, headache, dizziness, joint pain, back pain, decreased appetite, and muscle pain. The most common side effects of CRENESSITY in children include headache, stomach pain, tiredness, nasal congestion, and nosebleeds. These are not all the possible side effects of CRENESSITY. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. Dosage Forms and Strengths: CRENESSITY is available in 50 mg and 100 mg capsules, and as an oral solution of 50 mg/mL. Please see full Prescribing Information. About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, CRENESSITY and CAHtalyst are registered trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from CRENESSITY for the treatment of classic congenital adrenal hyperplasia (CAH); the value and benefits CRENESSITY brings to patients with CAH, including its potential to target adrenocorticotropic hormone (ACTH) and improve hormonal control in patients with CAH due to 11β-hydroxylase deficiency; the ability of Neurocrine Biosciences to ensure patients have access to CRENESSITY; and whether the results from our clinical trials of CRENESSITY are indicative of real-world results. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of CRENESSITY; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of CRENESSITY, including the extent to which patients and physicians accept and adopt CRENESSITY; whether CRENESSITY receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; risks associated with the Company's dependence on third parties for development and manufacturing activities related to CRENESSITY, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for CRENESSITY may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding CRENESSITY; risks that post-approval CRENESSITY commitments or requirements may be delayed; risks that CRENESSITY may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2026 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-CFT-US-0062 06/2026 SOURCE Neurocrine Biosciences, Inc. |
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2026-06-15 20:34
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2026-06-15 16:10
2mo ago
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Soleno Therapeutics Presents New VYKAT® XR (diazoxide choline) Data at ENDO 2026 Demonstrating Meaningful and Durable Improvements in Hyperphagia and Behavioral Symptoms in Prader-Willi Syndrome Following Randomized Withdrawal Period | FMP Stock News | |
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Original source text
Participants who resumed VYKAT XR following a 16-week randomized withdrawal period demonstrated improvements in hyperphagia and behavioral symptoms as early as Week 13, with benefits continuing through 2 years VYKAT XR demonstrated statistically significant and sustained improvements in hyperphagia and Prader-Willi syndrome-related behaviors for up to 3 years compared to real-world data from the PATH for PWS Natural History Study , /PRNewswire/ -- Soleno Therapeutics, a Neurocrine Biosciences (Nasdaq: NBIX) company, today announced late-breaking data at ENDO 2026 showing that resuming treatment with VYKAT® XR (diazoxide choline) extended-release tablets for two years after a 16-week randomized withdrawal period was associated with durable improvements in hyperphagia and behavioral symptoms characteristic of Prader-Willi syndrome (PWS). "These compelling data further reinforce our confidence in VYKAT XR as a safe and effective long-term treatment for hyperphagia in individuals four years of age and older living with Prader-Willi syndrome," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "Individuals who resumed treatment following the randomized withdrawal period achieved durable improvements in hyperphagia and other PWS-related behaviors. This completes the presentation of data from our comprehensive Phase 3 development program and further confirms the long-term benefit of VYKAT XR for people living with PWS." The VYKAT XR Phase 3 development program was conducted sequentially, including: A 13-week randomized, double-blind, parallel-arm study (C601) comparing VYKAT XR to placebo in participants four years of age and older with hyperphagia associated with genetically confirmed PWS An open-label extension study (C602 OLE) over approximately two to four years A 16-week, double-blind, placebo-controlled randomized withdrawal period An open-label long-term extension study (C614) Study C614, the open-label long-term extension study, enrolled 77 participants (mean age, 15.3 years; 55.8% female). The study assessed whether participants who had received placebo during the randomized withdrawal period could regain treatment benefit after restarting VYKAT XR, and whether participants who remained on continuous VYKAT XR maintained benefit over time. Hyperphagia was assessed using the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) and PWS-related behaviors were assessed using the PWS Profile questionnaire (PWSP). BMI and long-term safety were also assessed. Study results included: Participants who restarted VYKAT XR after placebo during the randomized withdrawal showed marked improvements in HQ-CT Total Score by Week 13 (mean [SD], -4.5 [6.3]), with further improvement observed at Week 26 and at two years (-5.5 [7.1] and -6.3 [8.4], respectively). Participants who remained on VYKAT XR continuously showed smaller improvements (-2.7 [6.9]) at Week 13 that were sustained at Week 26 and at two years (-3.3 [5.7] and -3.1 [8.0], respectively), underscoring the benefit of uninterrupted therapy. Improvements across all six PWSP behavioral domains were observed at two years in participants who restarted VYKAT XR, and BMI remained relatively stable throughout. These data show that participants who resumed VYKAT XR after randomized withdrawal experienced recovery of treatment benefit, while those who continued therapy maintained durable improvements in hyperphagia and other PWS-related behaviors. Study results were presented as, "Efficacy and Safety of Resuming Diazoxide Choline Extended-Release (DCCR) after 16-week Randomized Withdrawal in Prader-Willi Syndrome (Study C614)," which was authored by Jennifer L. Miller, M.D., University of Florida, Gainesville. Additional presentations at ENDO 2026: VYKAT XR Outcomes Compared to Real-World Data from PATH for PWS Natural History Study (PATH): Long-Term Reductions in Hyperphagia: HQ-CT Analysis A poster presentation led by Evelien F. Gevers, M.D., Ph.D., Barts Health NHS Trust/Queen Mary University of London, reported three-year data comparing 125 VYKAT XR-treated participants from Studies C601 and C602-OLE to 229 natural history controls from the PATH for PWS Natural History Study. VYKAT XR demonstrated statistically significant and sustained improvements in hyperphagia compared with the PATH cohort at all evaluated time points (p<0.0001), with treatment differences of 6.2 points at Year 1, 6.5 points at Year 2, and 6.2 points at Year 3 on the HQ-CT Total Score. Long-Term Behavioral Improvements: PWSP Analysis A second presentation by Dr. Gevers reported PWSP data comparing 105 VYKAT XR-treated participants to 182 PATH controls over three years. Statistically significant improvements favoring VYKAT XR compared with the PATH cohort were observed across all six behavioral domains at Year 1 (p<0.001), Year 2 (p<0.01), and Year 3 (p<0.001). At Year 3, VYKAT XR demonstrated consistent improvements across all assessed behavioral domains versus the PATH cohort, with adjusted mean differences favoring VYKAT XR of -2.5 in anxiety, -2.4 in rigidity/irritability, -2.3 in compulsivity, -2.1 in aggressive behaviors, -1.5 in disordered thinking, and -1.1 in depression. About PWS Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15. The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterized by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease. About VYKAT® XR VYKAT XR was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025, and is now commercially available to U.S. patients. VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). IMPORTANT SAFETY INFORMATION Contraindications Use of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides. Warnings and Precautions Hyperglycemia Hyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia. Risk of Fluid Overload Edema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients. Adverse Reactions The most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash. Please see the full Prescribing Information, including Medication Guide. About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. SOLENO and VYKAT are registered trademarks of Soleno Therapeutics, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from VYKAT XR for the treatment of Prader-Willi syndrome (PWS); the value and benefits VYKAT XR brings to patients with PWS, including its potential to support sustained and durable improvements in hyperphagia and PWS-related behavioral symptoms; and whether the results from clinical studies and other data analyses described in this press release are indicative of real-world results. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy, safety, or other clinical outcomes in subsequent clinical studies or real-world use of VYKAT XR; risks and uncertainties associated with our business and finances in general, as well as risks and uncertainties associated with the commercialization of VYKAT XR, including the extent to which patients and physicians accept and adopt VYKAT XR; whether VYKAT XR receives adequate coverage and reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for VYKAT XR; risks associated with dependence on third parties for development and manufacturing activities related to VYKAT XR, and risks associated with managing these third parties; risks that additional regulatory submissions for VYKAT XR may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding VYKAT XR; risks that post-approval commitments or requirements for VYKAT XR may be delayed; risks that VYKAT XR may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in Neurocrine Biosciences' periodic reports filed with the Securities and Exchange Commission, including without limitation Neurocrine Biosciences' quarterly report on Form 10-Q for the quarter ended March 31, 2026, and with respect to risks relating to VYKAT XR and Soleno Therapeutics, certain risks described in Soleno Therapeutics' annual report on Form 10-K for the year ended December 31, 2025, as updated by Soleno Therapeutics' quarterly report on Form 10-Q for the quarter ended March 31, 2026. Neurocrine Biosciences and Soleno Therapeutics disclaim any obligation to update the statements contained in this press release after the date hereof except as required by law. SOURCE Neurocrine Biosciences, Inc. |
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Saved
2026-06-15 12:54
2mo ago
Published
2026-06-15 08:30
2mo ago
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Neurocrine Biosciences Presents New Two-Year CRENESSITY® (crinecerfont) Data Demonstrating Improvements in Cardiometabolic Outcomes in Adults with Classic Congenital Adrenal Hyperplasia at ENDO 2026 | FMP Stock News | |
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Original source text
Two-year CRENESSITY data in adults showed improvements in cardiometabolic outcomes of insulin resistance, body composition and body weight alongside sustained reductions in glucocorticoid dose Among participants who were overweight or obese at baseline, 37% achieved >5% reduction in body weight at 2 years, and 43% of those with insulin resistance at baseline were no longer insulin resistant at 2 years Favorable trends in bone health outcomes were observed with CRENESSITY treatment, including improvements in bone mineral density with up to 2 years of treatment Patient‑reported survey data from adults in the open-label extension suggested improvements in quality of life outcomes and treatment satisfaction, including emotional well‑being, energy levels and confidence in managing their classic congenital adrenal hyperplasia with CRENESSITY , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new Phase 3 CAHtalyst® Adult study data demonstrating improved cardiometabolic outcomes alongside sustained glucocorticoid dose reduction through up to two years of treatment with CRENESSITY® (crinecerfont) for classic congenital adrenal hyperplasia. These results, together with additional presentations highlighting improvement in bone outcomes and patient-reported quality of life survey outcomes, were presented at the Endocrine Society's annual meeting, ENDO 2026, in Chicago.Long-term supraphysiologic glucocorticoid (GC) treatment in adults with classic congenital adrenal hyperplasia (CAH) is associated with obesity, insulin resistance, increased cardiometabolic risk and adverse effects on bone health. In these analyses, adults with classic CAH taking CRENESSITY for up to two years experienced improvements in weight, body composition and insulin resistance, key markers of long-term health, with sustained GC dose reductions and maintenance of baseline androgen control. "These two-year results provide important evidence on the long-term impact of CRENESSITY for adults living with classic congenital adrenal hyperplasia," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "Sustained improvements across key clinical outcomes, including both cardiometabolic and bone outcomes, underscore the potential of CRENESSITY to meaningfully redefine lifelong disease management and improve health. We are excited to share these new data with the scientific community as we continue to deepen our understanding of the long-term impact of CRENESSITY on patient outcomes and quality of life." CAHtalyst adult participants (N=182) who completed the 24-week, double-blind, placebo-controlled period and the subsequent six-month, open-label period of the study continued treatment with CRENESSITY in an ongoing open-label extension. Sustained Improvements in Weight‑related and Metabolic Outcomes over Two Years Cardiometabolic clinical outcomes were evaluated through up to two years of CRENESSITY treatment, including changes in body weight, body mass index (BMI), body composition and insulin resistance, as assessed by the homeostatic model assessment for insulin resistance (HOMA‑IR) at Months 12 and 24. To avoid potential confounding from glucagon-like peptide-1 (GLP-1) receptor agonists and/or glucose-dependent insulinotropic polypeptide (GIP) use, data from participants taking these medications (n=9) were excluded from the time the medication was started. Sustained improvements were observed, with mean reductions from baseline in body weight, BMI and insulin resistance. Among participants who were overweight or obese at baseline, more than one-third achieved clinically meaningful weight loss (>5%) at two years, with reductions in fat mass exceeding changes in lean mass. Improvements in insulin resistance were also sustained through two years, including among participants with insulin resistance at baseline, 43% of whom were no longer insulin resistant at two years. Measure Baseline Change from Baseline at Month 12 Change from Baseline at Month 24 Mean daily GC dose (mg/m²/day HCe*) 17.6 -6.8 (‑37%) -7.0 (‑38%) Mean BMI (kg/m2)†‡ 32.5 ‑0.9 ‑0.9 Percentage of overweight/obese participants who achieved >5% reduction in weight†‡ — 31% (35/114) 37% (35/95) Change in percent fat mass versus percent lean mass†‡ — ‑0.9% versus +0.7% ‑0.9% versus +0.8% Mean HOMA‑IR‡§ 5.3 ‑1.5 ‑1.7 Percentage of participants who achieved HOMA-IR ≤2.5‡§ — 40% (26/65) 43% (24/56) *HCe denotes hydrocortisone equivalents. †Among participants who were overweight or obese (BMI ≥25 kg/m2) at baseline. Clinically meaningful weight loss is defined as >5% reduction in body weight. ‡Data from participants who were taking a GIP/GLP-1 receptor agonist were excluded from the time the medication was started. §Among participants with insulin resistance (HOMA-IR >2.5) at baseline. "For many adults with classic congenital adrenal hyperplasia, long‑term supraphysiologic glucocorticoid exposure can contribute to weight gain and insulin resistance, adding to cumulative cardiometabolic burden over time," said Oksana Hamidi, D.O., M.S.C.S., Associate Professor of Internal Medicine, Division of Endocrinology, UT Southwestern Medical Center. "What makes these two-year data particularly meaningful is that they demonstrate sustained glucocorticoid reductions alongside improvements in insulin resistance and body composition, outcomes that are closely tied to future cardiometabolic risk and long-term health." Favorable Trends Observed Across Bone-related Outcomes Bone‑related outcomes were also assessed over two years of CRENESSITY treatment, including bone mineral density (BMD) z scores at Months 12, 18 and 24, and mean changes from baseline in bone turnover markers at Months 12 and 18. Favorable trends were observed in mineral density measurements (lumbar spine and total hip) and bone turnover (formation/resorption). BMD z scores trended toward incremental improvement over time, with the greatest improvement in the lumbar spine where there is the largest proportion of GC-sensitive bone. All bone turnover markers increased from baseline to Month 12, potentially reflecting recovery from suppression caused by supraphysiologic GC doses. From Month 12 to Month 18, markers of bone formation remained at similar levels, while markers of bone resorption showed a decreasing trend. Patient‑reported Survey Data Reflect Meaningful Changes in Lived Experience To understand patient perspectives following long‑term CRENESSITY treatment, a cross‑sectional survey was conducted among adult U.S. participants (n=48) at their final open-label extension visit. In the survey, 96% of respondents indicated they were moderately or very satisfied with their experience with CRENESSITY treatment, and a majority of participants reported: Having more hope for their future living with classic CAH (98%). Feeling more in control of their classic CAH (94%). Being more optimistic about reducing the long-term impacts of high-dose GCs (96%) and elevated adrenocorticotropic hormone or androgens (92%). Large majorities of participants who experienced improvements also reported those changes as meaningful, including less side effects associated with high-dose steroids (93%) and less worry about weight gain associated with high-dose steroids (81%), as well as high levels of treatment satisfaction, with 98% reporting they would recommend CRENESSITY and 96% reporting they preferred treatment with CRENESSITY over treatment without CRENESSITY. Across analyses, CRENESSITY was generally well tolerated through up to two years of treatment, with no new safety signals observed during long‑term follow‑up. These findings build on two‑year data presented earlier this year at the American Association of Clinical Endocrinology 2026 Annual Meeting and the Pediatric Endocrine Society 2026 Annual Meeting in adults and pediatrics, respectively. Presentations at the ENDO 2026 annual meeting included: CAHtalyst Adult Study Two-Year Results Title: Weight-Related Outcomes and Insulin Resistance in Adults with Classic Congenital Adrenal Hyperplasia: 2-Year Results from the CAHtalyst Adult Study (Oral Presentation #ORF32-07) Authors: Oksana Hamidi, D.O., et al Title: Adults with Classic Congenital Adrenal Hyperplasia Taking Crinecerfont Demonstrated Sustained Decreases in Glucocorticoid Doses: 2-Year Results from the CAHtalyst Adult Study (Poster Presentation #SUN-458) Authors: Irina Bancos, M.D., et al Title: A Cross-sectional Survey on Quality of Life of Adults with Classic Congenital Adrenal Hyperplasia in the United States Participating in CAHtalyst Adult Open-Label Extension Study (Poster Presentation #SUN-467) Authors: Sonal Vaid, M.D., et al Title: Bone Outcomes in Adults with Classic Congenital Adrenal Hyperplasia Treated with Crinecerfont for Up to 2 Years in CAHtalyst Adult Study (Poster Presentation #SUN-468) Authors: Maria Vogiatzi, M.D., et al CAHtalyst Pediatric Study Two-Year Results Title: Characterization of Children and Adolescents with Classic Congenital Adrenal Hyperplasia Who Had Slowed Bone Age Progression and Improved Height Prediction with Crinecerfont (Oral Presentation #ORF32-05) Authors: Maria Vogiatzi, M.D., et al Title: Long-term Crinecerfont Treatment Reduced ACTH and 17-Hydroxyprogesterone — Clinical Outcomes in Children and Adolescents with Classic Congenital Adrenal Hyperplasia: 2-Year Results from CAHtalyst Pediatric (Poster Presentation #SAT-465) Authors: Natalie Nokoff, M.D., et al Title: Long-term Crinecerfont Enables Sustained Decreases in Glucocorticoid Doses — Clinical Outcomes in Children and Adolescents with Classic Congenital Adrenal Hyperplasia: 2-Year Results from CAHtalyst Pediatric (Poster Presentation #SUN-465) Authors: Kyriakie Sarafoglou, M.D., et al Additional Presentations Title: Long-term Risk of Cardiometabolic Comorbidities Associated with Glucocorticoid Exposure and Androgen Control in Classic Congenital Adrenal Hyperplasia: A Cox Proportional Hazards Analysis from the CAHtalog Registry ("New Therapies and Perspectives for Congenital Adrenal Hyperplasia and Adrenal Insufficiency" Rapid Fire Presentation #ORF32-02 and Poster Presentation #MON-495) Authors: Oksana Lekarev, D.O., et al Title: Crinecerfont Treatment of Classic Congenital Adrenal Hyperplasia Due to 11β-Hydroxylase Deficiency: A Case Series (Poster Presentation #SAT-466) Authors: Kyriakie Sarafoglou, M.D., et al Title: A Modified Delphi Panel of U.S. Endocrinologists to Align on Minimum Clinically Important Difference in Glucocorticoid Dose and Other Key Considerations in Classic Congenital Adrenal Hyperplasia (Poster Presentation #SAT-459) Authors: Ahmed Khattab, M.D., et al About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is a rare genetic condition that results in an enzyme deficiency that alters the production of adrenal steroid hormones, such as cortisol, aldosterone and adrenal androgens. Severe enzyme deficiency leads to an inability of the adrenal glands to produce enough cortisol and, in approximately 75% of cases, aldosterone. Because individuals with CAH are typically still able to produce androgens, the unused precursors that would normally be used to make cortisol instead result in the production of excess amounts of androgens. If left untreated, CAH can result in adrenal crisis and even death. Exogenous glucocorticoids (GCs) are necessary to correct the endogenous cortisol deficiency, but historically, doses higher than those needed for cortisol replacement (supraphysiologic) have been used to lower the elevated levels of adrenocorticotropic hormone (ACTH) and adrenal androgens. However, GC treatment at supraphysiologic doses has been associated with serious and significant complications of steroid excess, including metabolic issues such as weight gain and diabetes, cardiovascular disease and osteoporosis. Additionally, long-term treatment with supraphysiologic GCs may have psychological and cognitive impacts, such as changes in mood and memory. Adrenal androgen excess has been associated with abnormal bone growth and development in pediatric patients, female health problems such as excess facial hair growth and menstrual irregularities, in addition to cardiometabolic and fertility issues in both sexes. The symptoms of high ACTH may include testicular adrenal rest tumors (TARTs). About CRENESSITY® (crinecerfont) CRENESSITY is a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist that reduces and controls excess adrenocorticotropic hormone (ACTH) and adrenal androgens through a non-glucocorticoid (GC) mechanism for the treatment of classic congenital adrenal hyperplasia (CAH). Antagonism of CRF1 receptors in the pituitary has been shown to decrease ACTH levels, which in turn decreases the production of adrenal androgens and potentially the symptoms associated with CAH. The robust clinical study data demonstrate that lowering adrenal androgen levels with CRENESSITY enables lower, more physiologic dosing of GCs to replace missing cortisol. CRENESSITY comes in capsules and an oral solution. For adults 18 years of age and older, the recommended dosage is 100 mg twice daily taken orally with a meal. For pediatric patients four to 17 years of age weighing less than 55 kg (121 lbs), the recommended dosage is based on body weight and is administered twice daily, taken orally with a meal. For pediatric patients weighing more than 55 kg (121 lbs), the recommended dosage is 100 mg twice daily taken orally with a meal. Healthcare providers can work with patients to determine the appropriate formulation for use depending on patient needs. Patients receiving CRENESSITY should continue GC therapy for cortisol replacement. About the CAHtalyst® Studies The Phase 3 CAHtalyst global registrational studies were designed to evaluate the safety, efficacy and tolerability of CRENESSITY® (crinecerfont) in children and adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The CAHtalyst studies were the largest-ever clinical trial program in classic CAH, including 285 pediatric and adult patients. The CAHtalyst Pediatric study included 103 pediatric patients four to 17 years of age. The study tested two questions. The first question evaluated whether four weeks of CRENESSITY treatment could improve androgen control. The second question evaluated whether an additional 24 weeks of CRENESSITY treatment enabled customized glucocorticoid (GC) down-titration while androstenedione levels were maintained or improved. The CAHtalyst Adult study included 182 adult patients 18 to 58 years of age. Similarly, the first question of the study evaluated whether four weeks of CRENESSITY treatment could improve androgen control, and the second question evaluated whether an additional 20 weeks of CRENESSITY treatment enabled GC reduction to physiologic range while androstenedione levels were maintained or improved. Data from the CAHtalyst Phase 3 studies supported approval of CRENESSITY by the U.S. Food and Drug Administration in December 2024. The open-label extension treatment portions of both studies are ongoing. Important Information Approved Uses CRENESSITY® (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH). IMPORTANT SAFETY INFORMATION Do not take CRENESSITY if you: Are allergic to crinecerfont, or any of the ingredients in CRENESSITY. CRENESSITY may cause serious side effects, including: Allergic reactions. Symptoms of an allergic reaction include tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash. If you have an allergic reaction to CRENESSITY, get emergency medical help right away and stop taking CRENESSITY. Risk of Sudden Adrenal Insufficiency or Adrenal Crisis with Too Little Glucocorticoid (Steroid) Medicine. Sudden adrenal insufficiency or adrenal crisis can happen in people with congenital adrenal hyperplasia who are not taking enough glucocorticoid (steroid) medicine. You should continue taking your glucocorticoid (steroid) medicine during treatment with CRENESSITY. Certain conditions such as infection, severe injury, or shock may increase your risk for sudden adrenal insufficiency or adrenal crisis. Tell your healthcare provider if you get a severe injury, infection, illness, or have planned surgery during treatment. Your healthcare provider may need to change your dose of glucocorticoid (steroid) medicine. Before taking CRENESSITY, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. The most common side effects of CRENESSITY in adults include tiredness, headache, dizziness, joint pain, back pain, decreased appetite, and muscle pain. The most common side effects of CRENESSITY in children include headache, stomach pain, tiredness, nasal congestion, and nosebleeds. These are not all the possible side effects of CRENESSITY. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. Dosage Forms and Strengths: CRENESSITY is available in 50 mg and 100 mg capsules, and as an oral solution of 50 mg/mL. Please see full Prescribing Information. About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, CRENESSITY and CAHtalyst are registered trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from CRENESSITY for the treatment of classic congenital adrenal hyperplasia (CAH); the value and benefits CRENESSITY brings to patients with CAH, including its potential support sustained glucocorticoid dose reductions and contribute to improvements in certain cardiometabolic, bone health and patient-reported outcomes; the ability of Neurocrine Biosciences to ensure patients have access to CRENESSITY; and whether the results from our clinical trials of CRENESSITY are indicative of real-world results. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of CRENESSITY; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of CRENESSITY, including the extent to which patients and physicians accept and adopt CRENESSITY; whether CRENESSITY receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; risks associated with the Company's dependence on third parties for development and manufacturing activities related to CRENESSITY, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for CRENESSITY may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding CRENESSITY; risks that post-approval CRENESSITY commitments or requirements may be delayed; risks that CRENESSITY may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2026 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-CFT-US-0063 06/2026 SOURCE Neurocrine Biosciences, Inc. |
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2026-06-15 12:54
2mo ago
Published
2026-06-15 08:35
2mo ago
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Neurocrine Biosciences Presents New Two-Year CRENESSITY® (crinecerfont) Data Demonstrating Improved Growth Measures in Pediatric Patients with Classic Congenital Adrenal Hyperplasia at ENDO 2026 | FMP Stock News | |
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Original source text
Two-year data showed that pediatric patients with accelerated bone age at baseline experienced slowed bone age progression and improved predicted adult height with CRENESSITY Cross-sectional caregiver survey data showed universal satisfaction with CRENESSITY, willingness to recommend treatment and increased optimism about their child's future quality of life following treatment initiation , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new two-year data from the Phase 3 CAHtalyst® Pediatric study showing positive growth outcomes in children and adolescents with classic congenital adrenal hyperplasia treated with CRENESSITY® (crinecerfont). Patients with advanced bone age at baseline experienced slowed bone age progression and improved predicted adult height after two years of treatment. These data were presented at the Endocrine Society's annual meeting, ENDO 2026, in Chicago."Treatment decisions made during growth years can have lifelong implications for children and adolescents with classic congenital adrenal hyperplasia," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "Excess adrenal androgens can accelerate bone maturation and limit adult height. These two‑year data suggest that sustained androgen control with CRENESSITY, combined with reduced glucocorticoid exposure, may help address abnormal growth in pediatric patients by slowing the advancement of bone age and narrowing the gap between bone age and chronological age." Pediatric participants who completed the 28‑week, double‑blind, placebo‑controlled period and the subsequent six‑month, open‑label period of the CAHtalyst Pediatric study continued treatment with CRENESSITY in an ongoing, open‑label extension. Slowed Bone Age Progression and Improved Predicted Adult Height In the subset of growing pediatric patients (n=41), changes in bone age and predicted adult height were evaluated at Month 24. Bone age was assessed using bone age standard deviation score (SDS), a measure that compares skeletal maturity to age- and sex-matched norms. Among those with advanced bone age at baseline (n=24), bone age SDS remained stable or improved in most patients with up to two years of CRENESSITY treatment. Mean bone age SDS decreased by 1.12, with a subset of patients (n=9) demonstrating reductions greater than two standard deviations. In this subset of patients, mean predicted adult height increased by 4.7 cm from baseline. Together the data suggest that sustained hormonal control and substantial glucocorticoid (GC) reductions enabled by CRENESSITY may positively influence growth during childhood and adolescence. "Accelerated bone age is one of the most challenging complications we face when managing classic congenital adrenal hyperplasia in growing children because it can permanently affect adult height," said Maria G. Vogiatzi, M.D., Division of Endocrinology at Children's Hospital of Philadelphia, Principal Investigator for the CAHtalyst Pediatric study and lead author of the growth analysis. "Seeing stabilization and even improvement in bone age over two years in a subset of patients is encouraging and suggests meaningful progress in addressing a key driver of compromised growth during the critical development years." Caregiver-reported Survey Data Reflects Satisfaction with CRENESSITY and Increased Optimism To further explore caregiver perspectives and patient experience following long-term treatment with CRENESSITY, a cross-sectional, caregiver-reported survey of eligible U.S. participants from the CAHtalyst Pediatric open-label extension (n=29; preliminary analysis) was conducted at patients' latest site visits. Among caregivers in the preliminary survey analysis, 100% (29/29) reported: Overall satisfaction with CRENESSITY. Likelihood to recommend CRENESSITY to others with classic congenital adrenal hyperplasia (CAH). Increased optimism about reducing risks of long-term impacts associated with high-dose steroid use, including 79% (23/29) who reported feeling less concern about steroid-associated weight gain. Nearly all respondents (97%, 28/29) reported greater overall hope for their child's future living with classic CAH, with 93% (27/29) indicating increased optimism about reducing long-term impact of high levels of adrenocorticotropic hormone and androgens. Across analyses, CRENESSITY was generally well tolerated through two years of treatment in pediatric patients, with no new safety signals observed during long‑term follow‑up. These analyses build on previously presented results showing that CRENESSITY enabled substantial, sustained reductions in mean GC dose over two years without compromising androgen control. Reduced GC exposure was associated with sustained improvements in clinical outcomes linked to long‑term, supraphysiologic GC use, including insulin resistance, weight and body mass index. These findings suggest a reduction in cardiometabolic risk in pediatric patients with classic CAH. Presentations at the ENDO 2026 annual meeting included: CAHtalyst Adult Study Two-Year Results Title: Weight-Related Outcomes and Insulin Resistance in Adults with Classic Congenital Adrenal Hyperplasia: 2-Year Results from the CAHtalyst Adult Study (Oral Presentation #ORF32-07) Authors: Oksana Hamidi, D.O., et al Title: Adults with Classic Congenital Adrenal Hyperplasia Taking Crinecerfont Demonstrated Sustained Decreases in Glucocorticoid Doses: 2-Year Results from the CAHtalyst Adult Study (Poster Presentation #SUN-458) Authors: Irina Bancos, M.D., et al Title: A Cross-sectional Survey on Quality of Life of Adults with Classic Congenital Adrenal Hyperplasia in the United States Participating in CAHtalyst Adult Open-Label Extension Study (Poster Presentation #SUN-467) Authors: Sonal Vaid, M.D., et al Title: Bone Outcomes in Adults with Classic Congenital Adrenal Hyperplasia Treated with Crinecerfont for Up to 2 Years in CAHtalyst Adult Study (Poster Presentation #SUN-468) Authors: Maria Vogiatzi, M.D., et al CAHtalyst Pediatric Study Two-Year Results Title: Characterization of Children and Adolescents with Classic Congenital Adrenal Hyperplasia Who Had Slowed Bone Age Progression and Improved Height Prediction with Crinecerfont (Oral Presentation #ORF32-05) Authors: Maria Vogiatzi, M.D., et al Title: Long-term Crinecerfont Treatment Reduced ACTH and 17-Hydroxyprogesterone — Clinical Outcomes in Children and Adolescents with Classic Congenital Adrenal Hyperplasia: 2-Year Results from CAHtalyst Pediatric (Poster Presentation #SAT-465) Authors: Natalie Nokoff, M.D., et al Title: Long-term Crinecerfont Enables Sustained Decreases in Glucocorticoid Doses — Clinical Outcomes in Children and Adolescents with Classic Congenital Adrenal Hyperplasia: 2-Year Results from CAHtalyst Pediatric (Poster Presentation #SUN-465) Authors: Kyriakie Sarafoglou, M.D., et al Additional Presentations Title: Long-Term Risk of Cardiometabolic Comorbidities Associated with Glucocorticoid Exposure and Androgen Control in Classic Congenital Adrenal Hyperplasia: A Cox Proportional Hazards Analysis from the CAHtalog Registry ("New Therapies and Perspectives for Congenital Adrenal Hyperplasia and Adrenal Insufficiency" Rapid Fire Presentation #ORF32-02 and Poster Presentation #MON-495) Authors: Oksana Lekarev, D.O., et al Title: Crinecerfont Treatment of Classic Congenital Adrenal Hyperplasia Due to 11β-Hydroxylase Deficiency: A Case Series (Poster Presentation #SAT-466) Authors: Kyriakie Sarafoglou, M.D., et al Title: A Modified Delphi Panel of U.S. Endocrinologists to Align on Minimum Clinically Important Difference in Glucocorticoid Dose and Other Key Considerations in Classic Congenital Adrenal Hyperplasia (Poster Presentation #SAT-459) Authors: Ahmed Khattab, M.D., et al About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is a rare genetic condition that results in an enzyme deficiency that alters the production of adrenal steroid hormones, such as cortisol, aldosterone and adrenal androgens. Severe enzyme deficiency leads to an inability of the adrenal glands to produce enough cortisol and, in approximately 75% of cases, aldosterone. Because individuals with CAH are typically still able to produce androgens, the unused precursors that would normally be used to make cortisol instead result in the production of excess amounts of androgens. If left untreated, CAH can result in adrenal crisis and even death. Exogenous glucocorticoids (GCs) are necessary to correct the endogenous cortisol deficiency, but historically, doses higher than those needed for cortisol replacement (supraphysiologic) have been used to lower the elevated levels of adrenocorticotropic hormone (ACTH) and adrenal androgens. However, GC treatment at supraphysiologic doses has been associated with serious and significant complications of steroid excess, including metabolic issues such as weight gain and diabetes, cardiovascular disease and osteoporosis. Additionally, long-term treatment with supraphysiologic GCs may have psychological and cognitive impacts, such as changes in mood and memory. Adrenal androgen excess has been associated with abnormal bone growth and development in pediatric patients, female health problems such as excess facial hair growth and menstrual irregularities, in addition to cardiometabolic and fertility issues in both sexes. The symptoms of high ACTH may include testicular adrenal rest tumors (TARTs). About CRENESSITY® (crinecerfont) CRENESSITY is a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist that reduces and controls excess adrenocorticotropic hormone (ACTH) and adrenal androgens through a non-glucocorticoid (GC) mechanism for the treatment of classic congenital adrenal hyperplasia (CAH). Antagonism of CRF1 receptors in the pituitary has been shown to decrease ACTH levels, which in turn decreases the production of adrenal androgens and potentially the symptoms associated with CAH. The robust clinical study data demonstrate that lowering adrenal androgen levels with CRENESSITY enables lower, more physiologic dosing of GCs to replace missing cortisol. CRENESSITY comes in capsules and an oral solution. For adults 18 years of age and older, the recommended dosage is 100 mg twice daily taken orally with a meal. For pediatric patients four to 17 years of age weighing less than 55 kg (121 lbs), the recommended dosage is based on body weight and is administered twice daily, taken orally with a meal. For pediatric patients weighing more than 55 kg (121 lbs), the recommended dosage is 100 mg twice daily taken orally with a meal. Healthcare providers can work with patients to determine the appropriate formulation for use depending on patient needs. Patients receiving CRENESSITY should continue GC therapy for cortisol replacement. About the CAHtalyst® Studies The Phase 3 CAHtalyst global registrational studies were designed to evaluate the safety, efficacy and tolerability of CRENESSITY® (crinecerfont) in children and adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The CAHtalyst studies were the largest-ever clinical trial program in classic CAH, including 285 pediatric and adult patients. The CAHtalyst Pediatric study included 103 pediatric patients four to 17 years of age. The study tested two questions. The first question evaluated whether four weeks of CRENESSITY treatment could improve androgen control. The second question evaluated whether an additional 24 weeks of CRENESSITY treatment enabled customized glucocorticoid (GC) down-titration while androstenedione levels were maintained or improved. The CAHtalyst Adult study included 182 adult patients 18 to 58 years of age. Similarly, the first question of the study evaluated whether four weeks of CRENESSITY treatment could improve androgen control, and the second question evaluated whether an additional 20 weeks of CRENESSITY treatment enabled GC reduction to physiologic range while androstenedione levels were maintained or improved. Data from the CAHtalyst Phase 3 studies supported approval of CRENESSITY by the U.S. Food and Drug Administration in December 2024. The open-label extension treatment portions of both studies are ongoing. Important Information Approved Uses CRENESSITY® (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH). IMPORTANT SAFETY INFORMATION Do not take CRENESSITY if you: Are allergic to crinecerfont, or any of the ingredients in CRENESSITY. CRENESSITY may cause serious side effects, including: Allergic reactions. Symptoms of an allergic reaction include tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash. If you have an allergic reaction to CRENESSITY, get emergency medical help right away and stop taking CRENESSITY. Risk of Sudden Adrenal Insufficiency or Adrenal Crisis with Too Little Glucocorticoid (Steroid) Medicine. Sudden adrenal insufficiency or adrenal crisis can happen in people with congenital adrenal hyperplasia who are not taking enough glucocorticoid (steroid) medicine. You should continue taking your glucocorticoid (steroid) medicine during treatment with CRENESSITY. Certain conditions such as infection, severe injury, or shock may increase your risk for sudden adrenal insufficiency or adrenal crisis. Tell your healthcare provider if you get a severe injury, infection, illness, or have planned surgery during treatment. Your healthcare provider may need to change your dose of glucocorticoid (steroid) medicine. Before taking CRENESSITY, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. The most common side effects of CRENESSITY in adults include tiredness, headache, dizziness, joint pain, back pain, decreased appetite, and muscle pain. The most common side effects of CRENESSITY in children include headache, stomach pain, tiredness, nasal congestion, and nosebleeds. These are not all the possible side effects of CRENESSITY. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. Dosage Forms and Strengths: CRENESSITY is available in 50 mg and 100 mg capsules, and as an oral solution of 50 mg/mL. Please see full Prescribing Information. About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, CRENESSITY and CAHtalyst are registered trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from CRENESSITY for the treatment of classic congenital adrenal hyperplasia (CAH); the value and benefits CRENESSITY brings to patients with CAH, including its potential to help address abnormal growth in pediatric patients with CAH by slowing bone age progression and improving predicted adult height in patients with advanced bone age at baseline; the ability of Neurocrine Biosciences to ensure patients have access to CRENESSITY; and whether the results from our clinical trials of CRENESSITY are indicative of real-world results. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of CRENESSITY; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of CRENESSITY, including the extent to which patients and physicians accept and adopt CRENESSITY; whether CRENESSITY receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; risks associated with the Company's dependence on third parties for development and manufacturing activities related to CRENESSITY, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for CRENESSITY may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding CRENESSITY; risks that post-approval CRENESSITY commitments or requirements may be delayed; risks that CRENESSITY may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2026 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-CFT-US-0061 06/2026 SOURCE Neurocrine Biosciences, Inc. |
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Saved
2026-06-12 20:03
2mo ago
Published
2026-05-05 09:00
4mo ago
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Neurocrine Biosciences to Present at the Bank of America Health Care Conference 2026 | FMP Stock News | |
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Original source text
, /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that its executives will participate at the Bank of America Health Care Conference 2026 at 11:20 a.m. Pacific Time (2:20 p.m Eastern Time) on May 12, 2026 in Las Vegas.The webcast can also be accessed on Neurocrine Biosciences' website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month. About Neurocrine Biosciences Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine, psychiatric and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. SOURCE Neurocrine Biosciences, Inc. |
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Saved
2026-06-12 20:03
2mo ago
Published
2026-05-05 16:01
4mo ago
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Neurocrine Biosciences Reports First-Quarter 2026 Financial Results | FMP Stock News | |
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Total First-Quarter 2026 Net Product Sales of $811.0 Million,An Increase of 44% Year-Over-Year Announced Definitive Agreement to Acquire Soleno Therapeutics, Including VYKATTM XR (diazoxide choline) for the Treatment of Hyperphagia in Prader-Willi Syndrome Expected to Close in Q2 2026 Initiated Phase 2 Clinical Study of NBI-1117570, a Dual M1 / M4 Selective Agonist, in Adults with Schizophrenia Reaffirmed 2026 Full-Year INGREZZA® (valbenazine) Net Sales Guidance of $2.7 - $2.8 Billion , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the first quarter ended March 31, 2026. "Neurocrine's strong first-quarter performance reflects continued momentum across our commercial portfolio, as we advance our growth strategy and diversify across therapeutic areas," said Kyle W. Gano, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We delivered $811 million in net product sales, representing 44% year-over-year growth, driven by continued strong demand for INGREZZA and CRENESSITY® (crinecerfont). Our recently announced agreement to acquire Soleno Therapeutics further underscores our commitment to address conditions with significant unmet need and accelerate revenue growth. With multiple first-in-class commercial medicines and the deepest pipeline in our history, Neurocrine is well-positioned to deliver transformative therapies for patients and drive sustained growth." Net Product Sales Highlights Total first-quarter 2026 net product sales were $811.0 million, representing 44% growth year-over-year. INGREZZA first-quarter 2026 net product sales were $656.9 million, representing 20% growth year-over-year. Results reflected double-digit prescription volume growth in TRx and record NRx driven by strong patient demand, partially offset by a lower net price compared to the first quarter of 2025. CRENESSITY first-quarter 2026 net product sales were $153.3 million, driven by strong patient demand with approximately 80% reimbursement for dispensed prescriptions in the first quarter 2026. Total revenues for the first quarter of 2026 were $814.5 million, compared with $572.6 million in the prior-year period, a 42% increase. Recent Clinical and Corporate Developments Entered into a definitive agreement to acquire Soleno Therapeutics for $53.00 per share in cash, representing a total transaction equity value of $2.9 billion. The addition of VYKAT™ XR (diazoxide choline), a first-in-class therapy to treat hyperphagia in Prader-Willi syndrome (PWS), is expected to expand Neurocrine's portfolio of innovative medicines and strengthen its leadership position in endocrinology and rare disease. The acquisition is anticipated to close in the second quarter of 2026. Initiated and dosed the first patients in a Phase 2 clinical study of NBI-1117570, a dual M1/M4 selective agonist in adults with schizophrenia. Initiated Phase 1 first-in-human clinical study evaluating the safety and tolerability of NBIP-'2118 in adult participants. NBIP-'2118 is an investigational corticotropin-releasing factor 2 receptor (CRF2) peptide agonist and a potential first-in-class therapy for obesity. Presented new real-world evidence demonstrating that adult patients with tardive dyskinesia receiving INGREZZA® (valbenazine) capsules showed higher treatment persistence compared to those on AUSTEDO XR (deutetrabenazine). The findings were presented at the Academy of Managed Care Pharmacy 2026 Annual Meeting in Nashville. Presented the first expert consensus recommendations focused on screening, diagnosis and treatment of tardive dyskinesia among older adults in long-term care settings. The recommendations address persistent gaps in recognizing and managing tardive dyskinesia in this higher-risk population. Findings were presented at the Society for Post-Acute and Long-Term Care Medical Association (PALTmed) PALTC26 Annual Conference in Anaheim, CA. Presented new two-year CRENESSITY data demonstrating durable hormonal control, reduced glucocorticoid exposure and meaningful clinical improvements in pediatric patients with classic congenital adrenal hyperplasia. The findings were presented at the Pediatric Endocrine Society 2026 Annual Meeting in San Francisco. Promoted Andrew Ratz, Ph.D., to the executive management team as the Chief Technical Operations Officer. In his new role, Dr. Ratz will lead the company's global technical development, manufacturing, and supply chain functions, supporting Neurocrine's expansion beyond small molecules into biologics and device-based therapies. First-Quarter 2026 Financial Results Three Months Ended March 31, (unaudited, in millions, except per share data) 2026 2025 Revenues: INGREZZA Net Product Sales $ 656.9 $ 545.2 CRENESSITY Net Product Sales 153.3 14.5 Other Revenues 4.3 12.9 Total Revenues $ 814.5 $ 572.6 GAAP Research and Development (R&D) $ 296.2 $ 263.2 Non-GAAP R&D $ 272.0 $ 240.2 GAAP Selling, General, and Administrative (SG&A) $ 318.5 $ 276.5 Non-GAAP SG&A $ 281.2 $ 245.3 GAAP Operating Income $ 193.4 $ 23.6 Non-GAAP Operating Income $ 226.4 $ 78.8 GAAP Net Income $ 197.9 $ 7.9 GAAP Earnings Per Share – Diluted $ 1.91 $ 0.08 Non-GAAP Net Income $ 200.5 $ 71.5 Non-GAAP Earnings Per Share – Diluted $ 1.94 $ 0.70 (unaudited, in millions) March 31, 2026 December 31, 2025 Total Cash, Cash Equivalents, and Marketable Securities $ 2,647.2 $ 2,543.4 Differences in first-quarter 2026 GAAP and Non-GAAP operating expenses compared with first-quarter 2025 were driven by: Increased R&D expense in support of an expanded and advancing pre-clinical and clinical portfolio including investments in osavampator Phase 3 program in major depressive disorder (MDD) and muscarinic franchise, including the direclidine Phase 3 program as a potential treatment for adults with schizophrenia. Development milestone expense included in R&D was $22.6 million and $45.4 million for the first quarter 2026 and 2025. Increased SG&A expense primarily reflected continued investment in our commercial organization, including the expansion of our INGREZZA and CRENESSITY sales teams in the first quarter of 2026. Increased acquired in-process research and development (IPR&D) expense associated with upfront payments for early-stage development candidates license agreements First-quarter 2026 GAAP net income and earnings per share were $197.9 million and $1.91, respectively, compared with $7.9 million and $0.08, respectively, for first-quarter 2025. First-quarter 2026 Non-GAAP net income and earnings per share were $200.5 million and $1.94, respectively, compared with $71.5 million and $0.70, respectively, for first-quarter 2025. Differences in first-quarter 2026 GAAP and Non-GAAP net income compared with first-quarter 2025 were primarily driven by: Higher net product sales of $247.3 million Increased operating expenses in support of expanding and advancing R&D portfolio, continued investment in our commercial organization, including the expansion of our INGREZZA and CRENESSITY sales teams. First quarter 2026 includes: $21.2 million of IPR&D expense associated with upfront payments for early-stage development candidates license agreements $22.6 million of development milestone included in R&D expense, compared with $45.4 million for first quarter 2025 A $25.3 million gain from changes in fair values of equity investments compared with a $30.6 million loss for first quarter 2025 (Non-GAAP adjustment) A $28.6 million pre-tax gain, net of transaction costs, related to the sale of Neurocrine Group Limited in January 2026 (Non-GAAP adjustment) At March 31, 2026, the Company had cash, cash equivalents, and marketable securities totaling approximately $2.65 billion. A reconciliation of GAAP to Non-GAAP financial results can be found in Table 3 and Table 4 at the end of this news release. Reaffirmed Full-Year 2026 Financial Guidance Range (in millions) Low High INGREZZA Net Product Sales 1 $ 2,700 $ 2,800 GAAP R&D Expense 2 $ 1,200 $ 1,250 Non-GAAP R&D Expense 2, 3 $ 1,110 $ 1,160 GAAP and Non-GAAP IPR&D 4 $ 20 $ 20 GAAP SG&A Expense 5 $ 1,375 $ 1,400 Non-GAAP SG&A Expense 3, 5 $ 1,240 $ 1,265 Full-Year 2026 financial guidance excludes any post-close expenses from the announced acquisition of Soleno Therapeutics, anticipated to close in Q2 2026. INGREZZA sales guidance reflects expected net product sales of INGREZZA in tardive dyskinesia and chorea associated with Huntington's disease. R&D guidance reflects the continued advancement of the Company's pre-clinical and clinical portfolio including the Phase 3 programs for osavampator in MDD and direclidine in schizophrenia, and includes approximately $25 million of expense for development milestones related to our in-licensed product candidates. Development milestones are included in R&D guidance once achieved or deemed probable to achieve. Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of approximately $90 million in R&D and $125 million in SG&A, divestiture-related expenses and vacated legacy campus facility costs. Non-cash stock-based compensation expense for performance-based equity awards is included in guidance once the predefined performance-based criteria for vesting is achieved or deemed probable to achieve. IPR&D guidance represents completed collaboration and licensing arrangements. SG&A guidance range reflects expense for ongoing commercial initiatives supporting INGREZZA growth and the launch of CRENESSITY including expansion of sales teams. Conference Call and Webcast Today at 4:30 PM Eastern Time Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 800-274-8461 (US) or 203-518-9814 (International) using the conference ID: NBIX. The webcast and accompanying slides can also be accessed at approximately 4:30 p.m. Eastern Time on Neurocrine Biosciences' website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month. About Neurocrine Biosciences Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neuropsychiatric, neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes U.S. FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, YOU DESERVE BRAVE SCIENCE, INGREZZA, and CRENESSITY are registered trademarks of Neurocrine Biosciences, Inc. Non-GAAP Financial Measures In addition to the financial results and financial guidance that are provided in accordance with accounting principles generally accepted in the United States (GAAP), this press release also contains the following Non-GAAP financial measures: Non-GAAP R&D expense, Non-GAAP SG&A expense, Non-GAAP operating income, Non-GAAP net income and net income per share. When preparing the Non-GAAP financial results and guidance, the Company excludes certain GAAP items that management does not consider to be normal, including recurring cash operating expenses that might not meet the definition of unusual or non-recurring items. In particular, these Non-GAAP financial measures exclude: non-cash stock-based compensation expense, vacated legacy campus facility costs, net of sublease income, non-cash amortization expense related to acquired intangible assets, changes in fair value of equity investments, transaction and divestiture-related gains and/or expenses, changes in foreign currency exchange rates and certain adjustments to income tax expense. These Non-GAAP financial measures are provided as a complement to results provided in accordance with GAAP as management believes these Non-GAAP financial measures help indicate underlying trends in the Company's business, are important in comparing current results with prior period results and provide additional information regarding the Company's financial position. Management also uses these Non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally and to manage the Company's business and evaluate its performance. The Company provides guidance regarding combined R&D and SG&A expenses on both a GAAP and a Non-GAAP basis. A reconciliation of these GAAP financial results to Non-GAAP financial results is included in the attached financial information. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: our business strategy, objectives, and future development plans; the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; successfully launching and commercializing CRENESSITY; our financial and operating performance, including our future revenues, expenses, or profits; our plans to acquire Soleno Therapeutics, including the anticipated timing and prospective benefits of the proposed acquisition, and our strategy, plans, objectives, expectations (financial or otherwise) and intentions with respect to our future financial results, growth potential and anticipated product portfolio in connection with the proposed acquisition; our collaborative partnerships; clinical and scientific data updates for our products and product candidates, including observations regarding clinical outcomes, safety, and tolerability; expected future clinical and regulatory milestones; and the timing of the initiation and/or completion of our clinical, regulatory, and other development activities and those of our collaboration partners. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements, include but are not limited to the following: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general; risks and uncertainties associated with the commercialization of INGREZZA and CRENESSITY; risks related to our ability to complete the proposed acquisition of Soleno Therapeutics on the proposed terms or on the proposed timeline, the possibility that competing offers or acquisition proposals will be made, the possibility that the transaction does not close, our ability to realize the anticipated benefits of the proposed acquisition, including the possibility that the expected benefits from the proposed acquisition will not be realized or will not be realized within the expected time period and that we will not be able to integrate Soleno Therapeutics' business successfully or that such integration may be more difficult, time-consuming or costly than expected, and the degree and pace of market uptake of Soleno Therapeutics' commercial product, VYKATTM XR (diazoxide choline); risks related to the development of our product candidates; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with government and third-party regulatory and/or policy efforts which may, among other things, impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products; risks associated with competition from other therapies or products, including potential generic entrants for our products; risks associated with our ability to manage the growth of our organization; and other risks described in our periodic reports filed with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than as required by law. TABLE 1NEUROCRINE BIOSCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (unaudited) Three Months Ended March 31, (in millions, except per share data) 2026 2025 Revenues: Net product sales $ 811.0 $ 563.7 Collaboration revenues 3.5 8.9 Total revenues 814.5 572.6 Operating expenses: Cost of revenues 13.8 9.2 Research and development 296.2 263.2 Acquired in-process research and development 21.2 0.1 Selling, general, and administrative 318.5 276.5 Gain on sale of business, net of transaction costs (28.6) — Total operating expenses 621.1 549.0 Operating income 193.4 23.6 Other income (expense): Unrealized gain (loss) on equity investments 25.3 (30.6) Investment income and other, net 28.1 21.7 Total other income (expense), net 53.4 (8.9) Income before provision for income taxes 246.8 14.7 Provision for income taxes 48.9 6.8 Net income $ 197.9 $ 7.9 Earnings per share, basic $ 1.97 $ 0.08 Earnings per share, diluted $ 1.91 $ 0.08 Weighted average common shares outstanding, basic 100.5 99.7 Weighted average common shares outstanding, diluted 103.4 102.5 TABLE 2NEUROCRINE BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (in millions) March 31, 2026 December 31, 2025 Cash, cash equivalents, and marketable securities $ 1,316.2 $ 1,480.4 Other current assets 1,119.9 1,042.3 Total current assets 2,436.1 2,522.7 Deferred tax assets 381.4 320.3 Marketable securities 1,331.0 1,063.0 Right-of-use assets 447.1 455.4 Equity investments 146.1 120.8 Property and equipment, net 90.9 89.8 Other noncurrent assets 73.6 59.5 Total assets $ 4,906.2 $ 4,631.5 Current liabilities $ 831.7 $ 743.4 Noncurrent operating lease liabilities 406.2 415.3 Other noncurrent liabilities 260.9 219.7 Stockholders' equity 3,407.4 3,253.1 Total liabilities and stockholders' equity $ 4,906.2 $ 4,631.5 TABLE 3NEUROCRINE BIOSCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS (unaudited) Three Months Ended March 31, (in millions) 2026 2025 GAAP operating income 1 $ 193.4 $ 23.6 Adjustments: Stock-based compensation expense - R&D 24.2 23.0 Stock-based compensation expense - SG&A 33.0 29.8 Gain on sale of business, net of transaction costs 2 (28.6) — Amortization of acquired intangible assets 0.1 1.0 Other 3 4.3 1.4 Non-GAAP operating income 1 $ 226.4 $ 78.8 Three Months Ended March 31, (in millions, except per share data) 2026 2025 GAAP net income 1 $ 197.9 $ 7.9 Adjustments: Stock-based compensation expense - R&D 24.2 23.0 Stock-based compensation expense - SG&A 33.0 29.8 Amortization of acquired intangible assets 0.1 1.0 Changes in fair values of equity investments 4 (25.3) 30.6 Gain on sale of business, net of transaction costs 2 (28.6) — Other 3 4.3 1.4 Income tax effect related to reconciling items 5 (5.1) (22.2) Non-GAAP net income 1 $ 200.5 $ 71.5 Diluted earnings per share: GAAP $ 1.91 $ 0.08 Non-GAAP $ 1.94 $ 0.70 1. Includes the following expenses: Three Months Ended March 31, (in millions) 2026 2025 Milestones (R&D) $ 22.6 $ 45.4 Acquired in-process research and development (IPR&D) $ 21.2 $ 0.1 2. Reflects a pre-tax gain, net of transaction costs, recognized on the sale of Neurocrine Group Limited in January 2026. 3. Primarily reflects transaction and divestiture-related expenses and other costs associated with our vacated legacy campus facilities, net of sublease income. 4. Reflects periodic fluctuations in the fair values of equity investments. 5. Estimated income tax effect of Non-GAAP reconciling items are calculated using applicable statutory tax rates, taking into consideration any valuation allowance. In addition, Non-GAAP tax expense may also be effected by certain non-recurring, non-operating, or discrete tax items. TABLE 4NEUROCRINE BIOSCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP EXPENSES (unaudited) Three Months Ended March 31, (in millions) 2026 2025 GAAP cost of revenues $ 13.8 $ 9.2 Adjustments: Amortization of acquired intangible assets 0.1 1.0 Non-GAAP cost of revenues $ 13.7 $ 8.2 Three Months Ended March 31, (in millions) 2026 2025 GAAP R&D $ 296.2 $ 263.2 Adjustments: Stock-based compensation expense 24.2 23.0 Non-GAAP R&D $ 272.0 $ 240.2 Three Months Ended March 31, (in millions) 2026 2025 GAAP SG&A $ 318.5 $ 276.5 Adjustments: Stock-based compensation expense 33.0 29.8 Other 4.3 1.4 Non-GAAP SG&A $ 281.2 $ 245.3 Three Months Ended March 31, (in millions) 2026 2025 GAAP other income (expense), net $ 53.4 $ (8.9) Adjustments: Changes in fair values of equity investments (25.3) 30.6 Non-GAAP other income, net $ 28.1 $ 21.7 SOURCE Neurocrine Biosciences, Inc. |
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2026-06-12 20:02
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Neurocrine Biosciences (NBIX) Beats Q1 Earnings and Revenue Estimates | FMP Stock News | |
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Neurocrine Biosciences (NBIX - Free Report) came out with quarterly earnings of $1.94 per share, beating the Zacks Consensus Estimate of $1.68 per share. This compares to earnings of $0.08 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +15.31%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $2.25 per share when it actually produced earnings of $1.88, delivering a surprise of -16.44%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Neurocrine, which belongs to the Zacks Medical - Drugs industry, posted revenues of $814.5 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 9.80%. This compares to year-ago revenues of $572.6 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Neurocrine shares have lost about 5.5% since the beginning of the year versus the S&P 500's gain of 5.2%. What's Next for Neurocrine?While Neurocrine has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Neurocrine was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $2.03 on $832.71 million in revenues for the coming quarter and $8.47 on $3.47 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the top 35% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Verrica Pharmaceuticals Inc. (VRCA - Free Report) , has yet to report results for the quarter ended March 2026. This company is expected to post quarterly loss of $0.59 per share in its upcoming report, which represents a year-over-year change of +41%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Verrica Pharmaceuticals Inc.'s revenues are expected to be $4.7 million, up 36.6% from the year-ago quarter. |
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