, /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.
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.
California 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.
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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.
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.
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.
Biopharmaceutical firm Neurocrine Biosciences, Inc. (NBIX) up over 35% in a year and 17% since outlier inflows in May.
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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:
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.
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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.
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.
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.
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.
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%.
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.
, /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.
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.
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.
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.
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.
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.
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.
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.
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.
, /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.
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)
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.
Neurocrine Biosciences (NBIX - Free Report) reported $814.5 million in revenue for the quarter ended March 2026, representing a year-over-year increase of 42.3%. EPS of $1.94 for the same period compares to $0.08 a year ago.
The reported revenue represents a surprise of +9.8% over the Zacks Consensus Estimate of $741.78 million. With the consensus EPS estimate being $1.68, the EPS surprise was +15.31%.
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- INGREZZA: $656.9 million compared to the $595.65 million average estimate based on eight analysts. The reported number represents a change of +20.5% year over year.Revenues- Product sales, net: $811 million versus the eight-analyst average estimate of $720.97 million. The reported number represents a year-over-year change of +43.9%.Revenues- Product sales, net- CRENESSITY: $153.3 million compared to the $121.77 million average estimate based on eight analysts.Revenues- Collaboration revenue: $3.5 million versus the seven-analyst average estimate of $7.72 million. The reported number represents a year-over-year change of -60.7%.Revenues- Product sales, net- Other: $4.3 million versus $4.1 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a +7.5% change.View all Key Company Metrics for Neurocrine here>>>
Shares of Neurocrine have returned +1.2% over the past month versus the Zacks S&P 500 composite's +9.5% change. The stock currently has a Zacks Rank #2 (Buy), indicating that it could outperform the broader market in the near term.
New algorithms developed by expert clinical endocrinologists provide clear, practical recommendations for healthcare providers to reduce supraphysiologic glucocorticoid (GC) doses in patients with classic congenital adrenal hyperplasia (CAH) after starting CRENESSITY CRENESSITY reduces excess androgen production, enabling patients with classic CAH to move toward more physiologic GC dosing while maintaining essential daily cortisol replacement , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the publication of the first peer-reviewed expert recommendations to guide glucocorticoid dose reduction in patients with classic congenital adrenal hyperplasia treated with CRENESSITY® (crinecerfont). Published in The Journal of Clinical Endocrinology & Metabolism, the recommendations address a critical unmet need as real-world use of CRENESSITY expands in both pediatric and adult patients.
The recommendations for clinicians treating classic congenital adrenal hyperplasia (CAH) patients with CRENESSITY are presented in two complementary manuscripts — one focused on pediatric patients aged four to 17 years and one focused on adults. The publications include the first structured, expert-driven algorithms for reducing supraphysiologic glucocorticoid (GC) dosing after initiating CRENESSITY in real-world clinical practice. CRENESSITY is approved as an adjunct treatment to GC replacement to control androgens in adult and pediatric patients four years of age and older with classic CAH.
"By reducing ACTH and downstream androgen production, CRENESSITY allows patients with classic CAH, including both salt-wasting and simple virilizing forms, to move toward more physiologic, cortisol-replacing glucocorticoid dosing," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "Blocking excess ACTH and androgen production while maintaining necessary cortisol replacement reflects an important shift in how the disease is managed, helping to lower risks associated with long-term exposure to supraphysiologic glucocorticoid doses."
In addition to the protocols used in the CAHtalyst® Pediatric and Adult Phase 3 clinical trials, clinicians now have expert-developed systematic approaches to adjusting GC doses in pediatric and adult patients treated with CRENESSITY. These recommendations, grounded in both clinical trial and real-world clinical experience, recognize that treatment goals and clinical considerations differ meaningfully between children and adults and provide two distinct algorithms tailored to each population:
Pediatric patients: The expert recommendations center on support to achieve normal growth and normalize bone age maturation and pubertal development while reducing long-term complications of excess GCs. GC reductions are targeted toward the upper portion of the physiologic range (8-11 mg/m2/day in hydrocortisone equivalents; full range 4-11 mg/m2/day) and are guided primarily by androgen concentrations, with close monitoring for GC withdrawal symptoms and adequate cortisol and mineralocorticoid replacement. Adult patients: The recommendations focus on minimizing GC-related metabolic, cardiovascular and skeletal complications while maintaining androgen control. GC reductions are targeted toward the physiologic range of 2-14 mg/m2/day in hydrocortisone equivalents and are paced according to current dose to manage any GC withdrawal symptoms and monitor for adequate cortisol replacement. "In children and adolescents with classic congenital adrenal hyperplasia, treatment decisions must carefully balance disease control with normal growth and development," said Mimi Kim, M.D., M.Sc., Associate Professor of Clinical Pediatrics, Keck School of Medicine, University of Southern California. "These recommendations provide clinicians with a structured, practical approach to glucocorticoid management that helps support growth, bone maturation and pubertal development as CRENESSITY is incorporated into care."
"CRENESSITY enables us to decouple androgen control from the need for supraphysiologic glucocorticoids in patients with classic congenital adrenal hyperplasia," said Oksana Hamidi, D.O., M.S.C.S., Associate Professor of Internal Medicine, Division of Endocrinology, UT Southwestern Medical Center. "This new framework provides an algorithm and practical steps clinicians can take to lower glucocorticoid exposure without compromising cortisol replacement, helping to realize the benefits of this novel therapeutic approach in day-to-day care."
GC reduction can offer important benefits for many patients and is therefore a common treatment goal with CRENESSITY. However, for some patients already taking a physiologic GC dose, CRENESSITY may be initiated to better manage androgens without increasing the GC dose. Key considerations outlined in both manuscripts include:
Dose reductions should be gradual and clinically supervised, with ongoing assessment for symptoms of GC withdrawal, adrenal insufficiency and mineralocorticoid imbalance. Healthcare providers should consider monitoring key biomarkers, which may include androstenedione, 17-hydroxyprogesterone, adrenocorticotropic hormone (ACTH), testosterone and markers of mineralocorticoid status, such as renin and electrolytes. GC dose reduction is not a universal goal; for some patients, the focus is androgens. The expert recommendation highlights that some individuals may already be receiving a physiologic GC dose and may initiate treatment with CRENESSITY solely for androgen control. Dose reduction should be considered only when appropriate, including when androgens are at or below goal and when clinical goals support reducing supraphysiologic GC exposure. The publications and new clinical algorithms can be accessed here:
1 Glucocorticoid Reduction After Starting Crinecerfont in Pediatric Patients with Classic CAH: Practical Perspectives.
2 Glucocorticoid Reduction After Starting Crinecerfont in Adult Patients with Classic CAH: Practical Perspectives.
*Figure reproduced from Nokoff NJ et al. J Clin Endocrinol Metab; 2026,1 distributed under the terms of the Creative Commons CC BY license
†Figure reproduced from Hamidi O, et al. J Clin Endocrinol Metab. 2026,2 distributed under the terms of the Creative Commons CC BY license
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 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)
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 enable patients to transition toward more physiologic glucocorticoid dosing; the clinical utility, adoption and impact of the newly published expert recommendations and algorithms for glucocorticoid dose reduction in pediatric and adult patients treated with CRENESSITY; 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 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.
Neurocrine Biosciences delivered a strong Q1, with revenue up 42% and healthy growth in Ingrezza and Crenessity. Enhanced sales efforts could drive Ingrezza upside in 2H'26, while Crenessity has a long runway for patient adoption, particularly in adults. The $2.9 billion Soleno acquisition brings Vykat XR, a high-potential offering with clear commercial synergies but significant unknowns around long-term patient uptake and compliance.
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. However, it isn't easy to find a great growth stock.
In addition to volatility, these stocks carry above-average risk by their very nature. Also, one could end up losing from a stock whose growth story is actually over or nearing its end.
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.
Our proprietary system currently recommends Neurocrine Biosciences (NBIX - Free Report) as one such stock. This 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 GrowthArguably nothing is more important than earnings growth, as surging profit levels is what most investors are after. 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 28.9%, investors should actually focus on the projected growth. The company's EPS is expected to grow 32.6% this year, crushing the industry average, which calls for EPS growth of 17.6%.
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 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 26.1% 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 5.4% over the past month.
Bottom LineWhile the overall earnings estimate revisions have made Neurocrine a Zacks Rank #2 stock, it has earned itself a Growth Score of A 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 indicates that Neurocrine is a potential outperformer and a solid choice for growth investors.
Richard Bungay appointed as CFO, bringing a strong track record in fundraising, M&A and partnering for listed and private companies, including two major exits and over $400m raised Cambridge, UK, 14 May 2026 – 4basebio PLC (AIM: 4BB), a specialist in synthetic DNA manufacturing and nucleic acids for next-generation therapeutics, announces the appointment of Richard Bungay as Chief Financial Officer, with effect from July 2026. Richard takes over the role from David Roth, who stepped down from the Board earlier this year and remained working with the Company over the orderly handover period.
Richard is an accomplished leader with over 30 years’ senior finance and strategic experience within the pharmaceutical and biotechnology sector, leading both public and private companies from research through all clinical phases, regulatory approval and commercialisation. He joins 4basebio from Sitala Bio Limited, a UK-based private biotech where he helped lead a strategic repositioning of the business, working closely with the CEO and board to raise a signficant Series A round and execute an in-licencing deal with Fosun Pharma for up to $670m.
Richard’s prior roles include CEO and CFO at Diurnal Group plc, where he led its acquisition by Neurocrine Biosciences, Inc. (Nasdaq: NBIX) in 2022 at a 147% one-day premium, CEO and CFO at Mereo Biopharma Group plc (NASDAQ: MREO), where he helped in-license a portfolio from Novartis and subsequently completed its AIM IPO, and CFO at Verona Pharma (then listed on the London Stock Exchange, now a subsidiary of Merck & Co) where he helped recapitalise the company.
Earlier in his career Richard was the Director of Corporate Communications and Strategic Planning at Celltech Group plc, a London-listed FTSE-100/250 company where he helped execute its acquisition by UCB for £1.5bn.
Richard is currently a Non-executive Director of Chroma Therapeutics Ltd. He qualified as a Chartered Accountant with Deloitte and has a First Class degree in Chemistry from Nottingham University.
Board Changes
Further to the above, Mr. Alexander Link, Non-executive Director and 2invest AG’s Board appointee, and Mr. Alan Malus, Non-executive Director, have stepped down from the Board with effect from 31 May 2026 due to other professional commitments. Dr. Heikki Lanckriet, Non-executive Director and former CEO of the Company will take over Mr Link’s role as the Board’s appointee of 2invest AG. It is the intention that Mr. Cornel Chiriac, representing M&G, will replace Mr. Malus, subject to the completion of due diligence and regulatory approval. The Directors would like to take this opportunity to thank Mr. Link and Mr. Malus for their contributions to the Board during their tenures.
Dr Amy Walker, Chief Executive Officer of 4basebio, said: “Richard has had a long and accomplished career in the industry, bringing significant experience with high growth public and private companies; we are thrilled that he has decided to join 4basebio. 4basebio is transitioning into a phase of accelerated commercial growth, and his strategic and financial expertise will be invaluable to support us on this journey. Richard’s appointment completes the build out of the senior leadership team to help us scale our operations to meet the growing need for high quality synthetic DNA products for advanced therapies and personalised medicines.”
Richard Bungay, Chief Financial Officer at 4basebio, added: “I’ve been following 4basebio’s progress for several years and have been impressed by what the team has achieved in such a short time. I look forward to working with Amy and the wider team to support the Company’s continued growth and help realise the growth potential of this exciting business as it seeks to establish a ledership position in the manufacturing of next-generation therapeutics.”
For further enquiries, please contact:
4basebio PLC +44 (0)12 2396 7943Dr Amy Walker, CEO Cairn Financial Advisers LLP (Nominated Adviser)+44 (0)20 7213 0880Jo Turner / Sandy Jamieson / Ed Downes Cavendish Capital Markets Limited (Joint Broker)+44 (0)20 7220 0500Geoff Nash / Nigel Birks RBC Capital Markets (Joint Broker)+44 (0)20 7653 4000Kathryn Deegan / Matthew Coakes ICR Healthcare (Media and Investor Relations)+44 (0)203 707 5700Mary-Jane Elliott / Jessica Hodgson About 4basebio
4basebio (AIM: 4BB) is a Cambridge-based biotechnology company pioneering the use of synthetic DNA to enable next-generation therapeutics and vaccines. Through its proprietary enzymatic DNA synthesis platform, 4basebio produces GMP-grade synthetic DNA and mRNA with superior speed, purity, and scalability, overcoming the limitations of plasmid-based systems. The company offers application-specific DNA constructs tailored to the diverse needs of gene therapies, genome editing, mRNA production, and DNA vaccines, helping partners accelerate proof-of-concept studies and reach clinical milestones more efficiently while maintaining the highest standards of safety and quality.
Strengthens Neurocrine's rare disease portfolio with VYKAT™ XR, the first and only approved treatment for hyperphagia in Prader-Willi syndrome Adds recently launched therapy with strong early adoption and meaningful commercial potential , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the completion of its acquisition of Soleno Therapeutics, Inc., strengthening the company's leadership in endocrinology and rare disease. The acquisition adds VYKAT™ XR (diazoxide choline) tablets, the first and only approved medicine for hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome, to Neurocrine's first-in-class commercial portfolio alongside INGREZZA® (valbenazine) and CRENESSITY® (crinecerfont).
"Today marks an important advancement in Neurocrine's mission to deliver life-changing treatments for patients with significant unmet needs," said Kyle W. Gano, Ph.D., Chief Executive Officer, Neurocrine Biosciences. "We welcome our Soleno colleagues to Neurocrine and share their deep commitment to the Prader-Willi syndrome community, and we look forward to working together to make VYKAT XR available to more patients and their families."
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in gene expression on chromosome 15 that affects about 10,000 patients in the United States. The disease is characterized by neurological, behavioral, and metabolic dysfunction. Its defining feature is hyperphagia, a chronic, life-threatening condition marked by a persistent hunger that drives compulsive food-seeking behavior. Individuals with PWS also commonly experience cognitive impairment and a range of psychiatric and behavioral challenges. Together, these symptoms can severely diminish quality of life for individuals with PWS and their families, with hyperphagia driving significant morbidity and mortality.
Neurocrine initially announced the transaction – representing a total equity value of $2.9 billion – on April 6, 2026.
Transaction Details
Neurocrine completed the cash tender offer through a subsidiary for all the outstanding shares of common stock of Soleno at a purchase price of $53.00 per share, without interest, subject to any applicable withholding taxes.
As of the tender offer expiration at one minute after 11:59 p.m. EDT on May 15, 2026, 46,356,114 shares of Soleno common stock were validly tendered and not validly withdrawn, representing approximately 88.9% of the total number of Soleno's issued and outstanding shares of common stock as of such date and time. In accordance with the terms of the tender offer, all such shares have been accepted for payment.
Following its acceptance of the tendered shares, Neurocrine completed its acquisition of Soleno through the merger of a direct wholly owned subsidiary of Neurocrine with and into Soleno, pursuant to Section 251(h) of the Delaware General Corporation Law on May 18, 2026, with Soleno continuing as the surviving corporation and becoming a direct, wholly owned subsidiary of Neurocrine. All remaining shares of Soleno common stock that were not validly tendered in the tender offer were converted into the right to receive the same $53 per share in cash, without interest, subject to any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer. As of May 18, 2026, Soleno's common stock will no longer be listed or traded on the Nasdaq Capital Market.
Advisors
Goldman Sachs & Co. LLC served as exclusive financial advisor, and Cooley LLP served as legal advisor to Neurocrine. Centerview Partners LLC and Guggenheim Securities, LLC served as financial advisors, and Wilson Sonsini Goodrich & Rosati, Professional Corporation served as legal counsel to Soleno.
About PWS
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in 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 comorbidities such as diabetes, obesity, and cardiovascular disease.
About INGREZZA® (valbenazine)
Please see additional safety information, full Prescribing Information, including Boxed Warning, and Medication Guide.
About CRENESSITY® (crinecerfont)
Please see additional safety information and full Prescribing Information.
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).
INDICATION
VYKAT XR (diazoxide choline) extended-release tablets 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
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, 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, INGREZZA and CRENESSITY are registered trademarks of Neurocrine Biosciences, Inc. SOLENO is a registered trademark of Soleno Therapeutics, Inc. VYKAT is a trademark of Soleno Therapeutics, Inc.
Forward-Looking Statements
This communication contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Neurocrine, including statements regarding Neurocrine's acquisition of Soleno, the prospective benefits of the acquisition; Neurocrine's strategy, plans, objectives, expectations (financial or otherwise) and intentions with respect to its future financial results and growth potential, anticipated product portfolio, and development programs; the estimated occurrence of PWS; the estimated U.S. population of PWS patients; and other statements that are not historical facts. The forward-looking statements contained in this communication are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. These statements may contain words such as "anticipate," "believe," "could," "estimate," "expect," "future," "intend," "may," "opportunity," "plan," "potential," "project," "seek," "should," "strategy," "will," "would" or other similar words and expressions indicating future results. Risks that may cause these forward-looking statements to be inaccurate include, without limitation: risks related to Neurocrine's ability to realize the anticipated benefits of the acquisition, 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 Neurocrine will not be able to integrate Soleno 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; negative effects of the consummation of the acquisition on the market price of Neurocrine's common stock and/or Neurocrine's operating results, including the possibility that if Neurocrine does not achieve the perceived benefits of the acquisition as rapidly or to the extent anticipated by financial analysts or investors, the market price of Neurocrine's common stock could decline; significant transaction and integration costs; unknown or inestimable liabilities; the risk of litigation and/or regulatory actions related to the acquisition; Neurocrine's ability to effectively commercialize VYKAT™ XR (diazoxide choline); the degree and pace of market uptake of VYKAT XR; obtaining and maintaining adequate coverage and reimbursement for Neurocrine's products, including VYKAT XR; the time-consuming and uncertain regulatory approval process; the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials; global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to Neurocrine's business operations and financial results; the sufficiency of Neurocrine's cash flows and capital resources; Neurocrine's ability to achieve targeted or expected future financial performance and results and the uncertainty of future tax, accounting and other provisions and estimates; and other risks and uncertainties affecting Neurocrine, including those described from time to time under the caption "Risk Factors" and elsewhere in Neurocrine's filings and reports with the U.S. Securities and Exchange Commission ("SEC"), including Neurocrine's Quarterly Report on Form 10-Q for the period ended March 31, 2026. Any forward-looking statements are made based on the current beliefs and judgments of Neurocrine's management team, and the reader is cautioned not to rely on any forward-looking statements made by Neurocrine. Except as required by law, Neurocrine does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
Clinician survey showed 90% of patients with mild tardive dyskinesia experienced emotional, social or physical impairment Following initiation of INGREZZA, 96% of patients with mild tardive dyskinesia showed clinician-reported improvement in uncontrolled movements; of those patients, 86% improved within 4 weeks Reductions in involuntary movements with INGREZZA treatment were associated with improvements in overall functional status, independence, activities of daily living and ability to work , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of new data from a clinician survey highlighting the functional impact experienced by patients with mild tardive dyskinesia (TD) severity and the impact of treatment with INGREZZA® (valbenazine) capsules in a real-world setting. In a subgroup analysis, nearly all patients with clinician-reported mild TD treated with INGREZZA experienced fewer uncontrolled movements, with most demonstrating symptom improvement within four weeks. Patients also showed widespread improvements in functional status, independence, ability to perform daily activities and ability to work. The findings are being presented at the American Psychiatric Association 2026 Annual Meeting, taking place May 16-20 in San Francisco.
"A growing body of evidence shows that even tardive dyskinesia identified as mild in severity can meaningfully disrupt patients' daily functioning, impacting their physical, social and emotional well-being," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "These real-world results complement previously published patient-reported data highlighting both the functional impact of mild involuntary movements and the potential benefits of INGREZZA treatment. INGREZZA has been shown to improve tardive dyskinesia and associated functional outcomes that can help patients reclaim their independence and resume everyday activities."
The analysis was based on a previously conducted clinician survey of patient chart data and clinician recall evaluating TD symptoms, functional impairment and improvement following treatment with INGREZZA. The survey included adult patients with TD who initiated INGREZZA between January 1, 2024 and June 30, 2024, completed at least two months of treatment and had at least one follow-up visit. In total, 128 clinicians caring for 315 patients with TD on INGREZZA reported data.
This analysis focused on a subgroup of patients (n=90) with mild movement severity as rated by clinicians using global severity categories aligned with the Abnormal Involuntary Movement Scale. Prior to treatment, clinicians reported that mild TD movements impacted functional status in 90% of patients and independence in 84% of patients, with commonly affected areas including emotional (88%), social (86%), speech (61%), dexterity (60%) and eating (56%) functions.
Following the initiation of INGREZZA, nearly all patients (96%) with mild TD experienced clinician-reported improvements in uncontrolled movements. Of those patients, 86% improved in four weeks or less. Beyond improvements in uncontrolled movements, clinicians observed meaningful functional improvements across a range of daily life domains among patients with mild TD:
For patients with impacted functional status (n=81), almost all (96%) had improvement in overall functional status. Across all functional items, clinicians reported improvement in more than 90% of impacted patients, including those with impacted speech (n=55), dexterity (n=54), social status (n=77), emotional status (n=79) and activities of daily living, such as eating (n=50) and self-care (n=44). Among all patients, 83% (n=75/90) achieved improvement in independence with treatment. Among patients who were employed or attending school, 70% (n=21/30) experienced improved willingness or ability to work or attend school after initiating treatment. Findings from this survey and subpopulation analysis support the American Psychiatric Association clinical guidelines, which state that treatment with a vesicular monoamine transporter 2 inhibitor can be considered for patients with mild TD based on associated impairment or patient preference. This research adds to the growing body of evidence demonstrating the benefits of INGREZZA in patients with TD, including those with mild movements. In clinical studies, including the Phase 4 KINECT-PRO™ study, INGREZZA has been shown to improve TD severity and patients have reported reductions in the physical, social and emotional burden of the condition. Together, these real-world and clinical data highlight the potential of INGREZZA to improve movements and associated functional outcomes in patients with TD, including those with mild involuntary movements prior to treatment.
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 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 validated in tardive dyskinesia patients that measures the physical, social and emotional impact of the involuntary movements of the condition.
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 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, INGREZZA and KINECT 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 expectations as to how such data may relate to the therapeutic effects and clinical efficacy of INGREZZA, 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 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.
, /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that its executives will participate at the following investor conferences:
William Blair 46th Annual Growth Stock Conference. Fireside chat on Tuesday, June 2, 2026 at 10:40 AM CT (11:40 AM ET) in Chicago Goldman Sachs 47th Annual Global Healthcare Conference 2026. Fireside chat on Tuesday, June 9, 2026 at 9:20 AM ET in Miami 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)
The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc.
Analyses span adult and pediatric populations with classic congenital adrenal hyperplasia (CAH) and reflect longer-term clinical outcomes relevant to disease management across lifespan and care continuum New data demonstrate the effect of CRENESSITY on long-term androgen control and glucocorticoid dose reduction and associated clinical outcomes Data from cross-sectional surveys highlight patient- and caregiver-reported quality of life improvements Case series highlights use of CRENESSITY in patients with classic CAH due to 11β‑hydroxylase deficiency Additional ENDO 2026 presentations include VYKAT™ XR (diazoxide choline) extended-release tablets data in hyperphagia associated with Prader-Willi syndrome (PWS), including late-breaking long-term extension findings following randomized withdrawal, and data evaluating sustained improvements in hyperphagia and behavioral symptoms through three years , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced it will present multiple new analyses of key clinical and patient-reported outcomes up to two years of treatment with CRENESSITY® (crinecerfont) in adult and pediatric populations with classic congenital adrenal hyperplasia. These data will be presented at the Endocrine Society's annual meeting, ENDO 2026, taking place from June 13-16, in Chicago.
The presentations will highlight the breadth of data generated from the CAHtalyst® clinical program's long‑term extension studies, reflecting Neurocrine's continued focus on advancing ongoing disease management in classic congenital adrenal hyperplasia (CAH). The data build on prior scientific presentations at recent medical meetings, including the American Association of Clinical Endocrinology 2026 Annual Meeting and the Pediatric Endocrine Society 2026 Annual Meeting. Together, these analyses extend the evaluation of longer‑term clinical and patient‑relevant outcomes associated with sustained androgen control and reduced glucocorticoid (GC) exposure.
"At ENDO 2026, we look forward to presenting compelling two-year treatment outcomes in patients with classic CAH treated with CRENESSITY," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "These data support the growing body of evidence around the meaningful long-term benefits of improved androgen control together with reduced exposure to high-dose glucocorticoids. This is the promise of treatment with CRENESSITY, which, together with lower-dose glucocorticoids, is rapidly becoming the new standard of care in classic CAH."
Across multiple adult and pediatric analyses presented at ENDO 2026, Neurocrine will share a range of endpoints intended to further characterize longer‑term outcomes relevant to patients and clinicians, including measures related to metabolic health, bone health, growth and development and patient‑reported quality of life.
In addition, Neurocrine will present a case series on the use of CRENESSITY in patients with classic CAH due to 11β‑hydroxylase deficiency, the second most common type of classic CAH after 21-hydroxylase deficiency, representing approximately 5% of all cases.
Neurocrine will share the following poster and oral presentations at ENDO 2026. All times are Central Time:
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
Date/Time: June 14 from 2:55-3:10 PM
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
Date/Time: June 14 from 12:00-1:30 PM
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
Date/Time: June 14 from 12:00-1:30 PM
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
Date/Time: June 14 from 12:00-1:30 PM
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
Date/Time: June 14 from 2:25-2:40 PM
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
Date/Time: June 13 from 12:15-1:45 PM
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
Date/Time: June 14 from 12:00-1:30 PM
Additional Presentations
Classic CAH:
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
Date/Time: June 14 from 1:50-1:55 PM (Rapid Fire) and June 15 from 9:00-2:00 PM (Poster)
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
Date/Time: June 13 from 12:15-1:45 PM
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
Date/Time: June 13 from 12:15-1:45 PM
PWS:
Title: (Late-breaker) Efficacy and Safety of Resuming Diazoxide Choline Extended-Release after 16-Week Randomized Withdrawal in Prader-Willi Syndrome (Study C614) (Poster Presentation #SUN-689)
Authors: Jennifer L. Miller, M.D., et al
Date/Time: June 14 from 12:00-1:30 PM
Title: Long-Term Reductions of Hyperphagia with Diazoxide Choline Extended-Release in Participants with Prader-Willi Syndrome (Poster Presentation #SUN-688)
Authors: Evelien F. Gevers, M.D., Ph.D., et al
Date/Time: June 14 from 12:00-1:30 PM
Title: Impact of Long-Term Diazoxide Choline Extended-Release Treatment and the Prader-Willi Syndrome Profile Questionnaire ("Hypothalamic and Genetic Disorders of Energy Balance" Rapid Fire Presentation #ORF44-02 and Poster Presentation #MON-690)
Authors: Evelien F. Gevers, M.D., Ph.D., et al
Date/Time: June 15 from 9:35-9:40 AM (Rapid Fire) and June 15 from 9:00-2:00 PM (Poster)
Title: Mortality Among Patients with Prader-Willi Syndrome (MAP-PWS): An Analysis of Healthcare Utilization in the Year Prior to Death Within a Single U.S. Payer (Poster Presentation #MON-863)
Authors: Isabella Niu, M.D., et al
Date/Time: June 15 from 12:00-1:30 PM
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 PWS
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in 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 comorbidities 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).
INDICATION
VYKAT XR (diazoxide choline) extended-release tablets 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, YOU DESERVE BRAVE SCIENCE, CRENESSITY and CAHtalyst are registered trademarks of Neurocrine Biosciences, Inc. SOLENO is a registered trademark of Soleno Therapeutics, Inc. VYKAT is a trademark 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 CRENESSITY for the treatment of classic congenital adrenal hyperplasia (CAH) and VYKAT XR for the treatment of Prader-Willi syndrome (PWS); the value and benefits CRENESSITY brings to patients with CAH, including its potential to support long-term hormone control and glucocorticoid dose reduction; the value and benefits VYKAT XR brings to patients with PWS, including its potential to support sustained improvements in hyperphagia and behavioral symptoms; the ability of Neurocrine Biosciences to ensure patients have access to CRENESSITY and VYKAT XR; and whether the results from our clinical trials 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 or other clinical outcomes in subsequent clinical studies or real-world use of CRENESSITY or VYKAT XR; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of CRENESSITY and VYKAT XR, including the extent to which patients and physicians accept and adopt CRENESSITY and VYKAT XR; whether CRENESSITY and VYKAT XR receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY or VYKAT XR; risks associated with the Company's dependence on third parties for development and manufacturing activities related to CRENESSITY and VYKAT XR, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for CRENESSITY or 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 CRENESSITY or VYKAT XR; risks that post-approval commitments or requirements for CRENESSITY or VYKAT XR may be delayed; risks that CRENESSITY or 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 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.
Analyses span adult and pediatric populations with classic congenital adrenal hyperplasia (CAH) and reflect longer-term clinical outcomes relevant to disease management across lifespan and care continuumNew data demonstrate the effect of CRENESSITY on long-term androgen control and glucocorticoid dose reduction and associated clinical outcomesData from cross-sectional surveys highlight patient- and caregiver-reported quality of life improvementsCase series highlights use of CRENESSITY in patients with classic CAH due to 11β‑hydroxylase deficiencyAdditional ENDO 2026 presentations include VYKAT™ XR (diazoxide choline) extended-release tablets data in hyperphagia associated with Prader-Willi syndrome (PWS), including late-breaking long-term extension findings following randomized withdrawal, and data evaluating sustained improvements in hyperphagia and behavioral symptoms through three years, /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced it will present multiple new analyses of key clinical and patient-reported outcomes up to two years of treatment with CRENESSITY® (crinecerfont) in adult and pediatric populations with classic congenital adrenal hyperplasia. These data will be presented at the Endocrine Society's annual meeting, ENDO 2026, taking place from June 13-16, in Chicago.
The presentations will highlight the breadth of data generated from the CAHtalyst® clinical program's long‑term extension studies, reflecting Neurocrine's continued focus on advancing ongoing disease management in classic congenital adrenal hyperplasia (CAH). The data build on prior scientific presentations at recent medical meetings, including the American Association of Clinical Endocrinology 2026 Annual Meeting and the Pediatric Endocrine Society 2026 Annual Meeting. Together, these analyses extend the evaluation of longer‑term clinical and patient‑relevant outcomes associated with sustained androgen control and reduced glucocorticoid (GC) exposure.
"At ENDO 2026, we look forward to presenting compelling two-year treatment outcomes in patients with classic CAH treated with CRENESSITY," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "These data support the growing body of evidence around the meaningful long-term benefits of improved androgen control together with reduced exposure to high-dose glucocorticoids. This is the promise of treatment with CRENESSITY, which, together with lower-dose glucocorticoids, is rapidly becoming the new standard of care in classic CAH."
Across multiple adult and pediatric analyses presented at ENDO 2026, Neurocrine will share a range of endpoints intended to further characterize longer‑term outcomes relevant to patients and clinicians, including measures related to metabolic health, bone health, growth and development and patient‑reported quality of life.
In addition, Neurocrine will present a case series on the use of CRENESSITY in patients with classic CAH due to 11β‑hydroxylase deficiency, the second most common type of classic CAH after 21-hydroxylase deficiency, representing approximately 5% of all cases.
Neurocrine will share the following poster and oral presentations at ENDO 2026. All times are Central Time:
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
Date/Time: June 14 from 2:55-3:10 PM
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
Date/Time: June 14 from 12:00-1:30 PM
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
Date/Time: June 14 from 12:00-1:30 PM
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
Date/Time: June 14 from 12:00-1:30 PM
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
Date/Time: June 14 from 2:25-2:40 PM
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
Date/Time: June 13 from 12:15-1:45 PM
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
Date/Time: June 14 from 12:00-1:30 PM
Additional Presentations
Classic CAH:
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
Date/Time: June 14 from 1:50-1:55 PM (Rapid Fire) and June 15 from 9:00-2:00 PM (Poster)
Title: Crinecerfont Treatment of Classic Congenital Adrenal Hyperplasia Due to 11β-Hydroxylase Deficiency: A Case Series (Poster Presentation #SAT-466)
Authors: KyriakieSarafoglou, M.D., et al
Date/Time: June 13 from 12:15-1:45 PM
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: AhmedKhattab, M.D., et al
Date/Time: June 13 from 12:15-1:45 PM
PWS:
Title: (Late-breaker) Efficacy and Safety of Resuming Diazoxide Choline Extended-Release after 16-Week Randomized Withdrawal in Prader-Willi Syndrome (Study C614) (Poster Presentation #SUN-689)
Authors: Jennifer L. Miller, M.D., et al
Date/Time: June 14 from 12:00-1:30 PM
Title: Long-Term Reductions of Hyperphagia with Diazoxide Choline Extended-Release in Participants with Prader-Willi Syndrome (Poster Presentation #SUN-688)
Authors: Evelien F. Gevers, M.D., Ph.D., et al
Date/Time: June 14 from 12:00-1:30 PM
Title: Impact of Long-Term Diazoxide Choline Extended-Release Treatment and the Prader-Willi Syndrome Profile Questionnaire ("Hypothalamic and Genetic Disorders of Energy Balance" Rapid Fire Presentation #ORF44-02 and Poster Presentation #MON-690)
Authors: Evelien F. Gevers, M.D., Ph.D., et al
Date/Time: June 15 from 9:35-9:40 AM (Rapid Fire) and June 15 from 9:00-2:00 PM (Poster)
Title: Mortality Among Patients with Prader-Willi Syndrome (MAP-PWS): An Analysis of Healthcare Utilization in the Year Prior to Death Within a Single U.S. Payer (Poster Presentation #MON-863)
Authors: Isabella Niu, M.D., et al
Date/Time: June 15 from 12:00-1:30 PM
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 PWS
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in 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 comorbidities 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).
INDICATION
VYKAT XR (diazoxide choline) extended-release tablets 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, YOU DESERVE BRAVE SCIENCE, CRENESSITY and CAHtalyst are registered trademarks of Neurocrine Biosciences, Inc. SOLENO is a registered trademark of Soleno Therapeutics, Inc. VYKAT is a trademark 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 CRENESSITY for the treatment of classic congenital adrenal hyperplasia (CAH) and VYKAT XR for the treatment of Prader-Willi syndrome (PWS); the value and benefits CRENESSITY brings to patients with CAH, including its potential to support long-term hormone control and glucocorticoid dose reduction; the value and benefits VYKAT XR brings to patients with PWS, including its potential to support sustained improvements in hyperphagia and behavioral symptoms; the ability of Neurocrine Biosciences to ensure patients have access to CRENESSITY and VYKAT XR; and whether the results from our clinical trials 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 or other clinical outcomes in subsequent clinical studies or real-world use of CRENESSITY or VYKAT XR; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of CRENESSITY and VYKAT XR, including the extent to which patients and physicians accept and adopt CRENESSITY and VYKAT XR; whether CRENESSITY and VYKAT XR receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY or VYKAT XR; risks associated with the Company's dependence on third parties for development and manufacturing activities related to CRENESSITY and VYKAT XR, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for CRENESSITY or 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 CRENESSITY or VYKAT XR; risks that post-approval commitments or requirements for CRENESSITY or VYKAT XR may be delayed; risks that CRENESSITY or 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 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.
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Nearly all individuals with intellectual and developmental disabilities experienced improvement in tardive dyskinesia severity after starting INGREZZA, and of those, 89% experienced improvement within 4 weeks Clinician-reported data showed improvements in key aspects of daily life following INGREZZA treatment in nearly all patients with tardive dyskinesia and intellectual and developmental disabilities who had impaired function , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new clinician-reported data in patients with intellectual and developmental disabilities demonstrating meaningful and rapid improvements in tardive dyskinesia severity, as well as improvements in overall functional status, including physical and socio-emotional outcomes, with INGREZZA® (valbenazine) capsules. The findings were presented at the American Academy of Developmental Medicine and Dentistry's 24th Annual Education Conference in Dallas.
These data highlight the significant burden associated with tardive dyskinesia (TD) in individuals with intellectual and developmental disabilities, as well as the rapid clinician-reported improvements seen in TD movements following treatment with INGREZZA. Clinicians also observed functional gains across multiple areas of daily living, including social and emotional well-being, communication abilities and motor skills, such as hand coordination.
"People with intellectual and developmental disabilities are at increased risk for tardive dyskinesia due to long-term antipsychotic use, yet the condition often goes underdiagnosed and its impact underrecognized," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "The clinician-reported improvements observed in this analysis complement patient-reported outcomes from the KINECT-PRO study, further highlighting the potential of INGREZZA to make a meaningful difference in areas that matter most to people living with tardive dyskinesia. This analysis, which is the first and only of its kind, also reflects our ongoing commitment to advancing studies that better represent and serve the diverse populations affected by the condition."
This analysis was based on clinician‑reported data from patients who initiated INGREZZA between January and June 2024, completed at least two months of treatment and had at least one follow‑up visit, including a subgroup of 30 individuals with reported intellectual and developmental disabilities (mean age: 47.3 years; standard deviation: 14.6). The most common psychiatric comorbidities in this subgroup were schizophrenia (70%) and mood disorders (17%). Clinicians also reported that 70% of individuals had moderate or severe TD movement severity at baseline.
Nearly all individuals experienced reductions in TD symptoms, with 89% (25/28) demonstrating improvement within four weeks of treatment initiation. Clinicians reported substantial burden associated with TD at baseline, with functional status and independence negatively impacted in 90% of individuals in the study due to their TD symptoms. Following treatment with INGREZZA, clinicians reported improvement in overall functional status in 96% of study participants with impaired function, as well as broad improvements across key aspects of daily life.
Outcome
Baseline: % Patients
Negatively Impacted
Posttreatment: % Patients
Improved*
Overall functional status
90 %
96 %
Independence
90 %
83 %
Emotions
90 %
85 %
Socializing with family and friends
83 %
92 %
Dexterity
73 %
91 %
Speech
53 %
100 %
*Percentage improved among patients who were negatively impacted at baseline
A previous publication examined the use of INGREZZA in five adults with mild to severe intellectual and developmental disabilities and TD. Following treatment with INGREZZA, patients experienced reduced TD movements, accompanied by improvements in daily functioning, demeanor and social and caregiver interactions. The present analysis extends those findings, emphasizing the need to recognize the burden of TD beyond uncontrolled movements, including functional and socio-emotional outcomes that are especially meaningful for patients with intellectual and development disabilities, as well as their families and care partners.
Additional presentation at the American Academy of Developmental Medicine and Dentistry's 24th Annual Education Conference included:
Use and Misuse of Anticholinergics for Drug Induced Movement Disorders 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 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 validated in tardive dyskinesia patients that measures the physical, social and emotional impact of the involuntary movements of the condition.
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 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, INGREZZA and KINECT 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 improvements in patients' functional status and physical and socio-emotional outcomes following treatment with INGREZZA, and the other 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 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.
New 48-week KINECT® 4 post-hoc analysis shows 94% of participants treated with INGREZZA achieved either symptomatic remission or a clinically meaningful response (≥30% reduction from baseline in Abnormal Involuntary Movement Scale total score); INGREZZA is the only vesicular monoamine transporter 2 (VMAT2) inhibitor to demonstrate clinical remission in clinical trials A separate claims analysis indicates high prevalence of hepatic risk factors among patients with tardive dyskinesia; INGREZZA is the only VMAT2 inhibitor with approved dosing in hepatic impairment Together, these data add to a growing body of evidence supporting the potential of INGREZZA to provide clinically meaningful therapeutic benefits to a wide range of patients with tardive dyskinesia , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new post-hoc data from the KINECT® 4 clinical trial demonstrating that adults with tardive dyskinesia (TD) treated with INGREZZA® (valbenazine) capsules experienced clinically meaningful and robust improvements in involuntary movement severity, including those who did not meet the stringent symptomatic remission threshold. These results, together with findings from a large retrospective Medicare claims analysis evaluating hepatic risk factors among patients newly diagnosed with TD, were presented at the 2026 Psych Congress Elevate in Las Vegas.
Previously presented data from the 48-week KINECT 4 study showed that 59% (61/103) of patients treated with once-daily INGREZZA achieved the stringent threshold for TD symptomatic remission, defined as an Abnormal Involuntary Movement Scale (AIMS) item score of 0 ("none") or 1 ("minimal movements") in each of the seven body regions. Symptomatic remission was achieved across TD movement severity subgroups, including 63% (38/60) of patients with moderate TD and 54% (23/43) of patients with severe TD. A new post-hoc analysis further demonstrated that clinically meaningful improvements were observed even among patients who did not meet the more stringent symptomatic remission threshold. Among the 41% of patients (42/103) who did not meet the symptomatic remission threshold at Week 48, 86% (36/42) achieved ≥30% total AIMS score reduction (characterized by the authors as clinically meaningful), and 67% (28/42) achieved ≥50% reduction.
"Treatment goals for tardive dyskinesia include achieving both meaningful reductions in movement severity and, when possible, reaching symptomatic remission, a stringent threshold characterized by absent or minimal involuntary movements across all seven body regions," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "This new analysis demonstrates that approximately 94% of patients treated with INGREZZA for 48 weeks either achieved symptomatic remission or experienced clinically meaningful reductions in their tardive dyskinesia movements. Notably, the benefits of treatment extended beyond patients who reached the stringent remission threshold, reinforcing the broad clinical impact of INGREZZA."
Claims Analysis Underscores Importance of Evaluating Hepatic Risk Factors in TD Treatment Decisions
A separate retrospective Medicare claims analysis of more than 176,000 patients newly diagnosed with TD found that 90% of patients had at least one hepatic risk factor and 44% had three or more. Selected hepatic risk factors included metabolic conditions, such as type 2 diabetes, hypertension, hyperlipidemia and obesity, in addition to substance use-related factors, such as alcohol or drug abuse, are associated with chronic liver disease or hepatic impairment. These findings highlight the importance of evaluating hepatic risk factors when making individualized treatment decisions for TD, as chronic liver disease may progress without noticeable symptoms, and hepatic impairment may go unrecognized, particularly in mild cases. INGREZZA is the only vesicular monoamine transporter 2 inhibitor with approved dosing for patients with TD and coexisting hepatic impairment.
Additional presentations at the 2026 Psych Congress Elevate included:
Evidence-Based Recommendations for Treating Tardive Dyskinesia with a Vesicular Monoamine Transporter 2 Inhibitor Clinically Meaningful Improvements and Symptomatic Remission with Once-Daily Valbenazine in Adults with Tardive Dyskinesia Patients Taking Once-Daily Valbenazine Report Improved Quality of Life/Functionality and Experience Remission of Tardive Dyskinesia Symptoms with Once-Daily Valbenazine: Findings From KINECT-PRO Once‑Daily Valbenazine Demonstrates Greater and More Predictable Exposure Than Deutetrabenazine Extended‑Release: Results from a Positron Emission Tomography Study in Healthy Male Adults Characterizing Hepatic Risk Factors Among Medicare Patients with Tardive Dyskinesia About the KINECT 4 Phase 3 Study
KINECT 4 is a Phase 3, open-label study in which 163 participants with moderate to severe TD and underlying schizophrenia, schizoaffective disorder or mood disorder (including bipolar disorder or major depressive disorder) received 48 weeks of open-label treatment with once-daily INGREZZA (40 mg or 80 mg capsules) followed by a four-week washout. Dosing was initiated at 40 mg/day in all participants, with escalation to 80 mg/day at Week 4 based on effectiveness and tolerability. Dose reduction to 40 mg was allowed in participants who could not tolerate the 80 mg dose. Patients were discontinued if the new dose was not tolerated.
Participants experienced TD improvements during long-term treatment as demonstrated by mean change from baseline to Week 48 in AIMS total score (sum of items 1-7, evaluated by site raters) with INGREZZA 40 mg/day (-10.2) or 80 mg/day (-11.0). Consistent with previous studies, INGREZZA was generally well tolerated. After Week 4, treatment-emergent adverse events that occurred in ≥5% of all participants (combined dose groups) were urinary tract infection (8.5%) and headache (5.2%). Changes from baseline in psychiatric stability, vital signs, electrocardiogram parameters and laboratory test values were generally small and not clinically significant.
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 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, INGREZZA and KINECT are registered trademarks of Neurocrine Biosciences, Inc. KINECT-PRO is a trademark 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 reductions in involuntary movement severity, symptomatic remission, and hepatic risk factors 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 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.
