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2026-06-12 11:53
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2026-04-23 15:41
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Banc of California, Inc. (BANC) Q1 2026 Earnings Call Transcript | FMP Stock News | |
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2026-06-12 11:53
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2026-04-27 12:46
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Why Banc of California (BANC) is a Top Dividend Stock for Your Portfolio | FMP Stock News | |
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All investors love getting big returns from their portfolio, whether it's through stocks, bonds, ETFs, or other types of securities. But when you're an income investor, your primary focus is generating consistent cash flow from each of your liquid investments.While cash flow can come from bond interest or interest from other types of investments, income investors hone in on dividends. A dividend is the distribution of a company's earnings paid out to shareholders; it's often viewed by its dividend yield, a metric that measures a dividend as a percent of the current stock price. Many academic studies show that dividends make up large portions of long-term returns, and in many cases, dividend contributions surpass one-third of total returns. Banc of California (BANC - Free Report) is headquartered in Los Angeles, and is in the Finance sector. The stock has seen a price change of -2.8% since the start of the year. The banking service and lending company is paying out a dividend of $0.12 per share at the moment, with a dividend yield of 2.56% compared to the Banks - Southwest industry's yield of 1.68% and the S&P 500's yield of 1.39%. Looking at dividend growth, the company's current annualized dividend of $0.48 is up 20% from last year. Over the last 5 years, Banc of California has increased its dividend 1 times on a year-over-year basis for an average annual increase of 16.61%. Looking ahead, future dividend growth will be dependent on earnings growth and payout ratio, which is the proportion of a company's annual earnings per share that it pays out as a dividend. Banc of California's current payout ratio is 32%, meaning it paid out 32% of its trailing 12-month EPS as dividend. BANC is expecting earnings to expand this fiscal year as well. The Zacks Consensus Estimate for 2026 is $1.74 per share, which represents a year-over-year growth rate of 28.89%. Investors like dividends for a variety of different reasons, from tax advantages and decreasing overall portfolio risk to considerably improving stock investing profits. However, not all companies offer a quarterly payout. For instance, it's a rare occurrence when a tech start-up or big growth business offers its shareholders a dividend. It's more common to see larger companies with more established profits give out dividends. Income investors have to be mindful of the fact that high-yielding stocks tend to struggle during periods of rising interest rates. With that in mind, BANC is a compelling investment opportunity. Not only is it a strong dividend play, but the stock currently sits at a Zacks Rank of #3 (Hold). |
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2026-06-12 11:53
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2026-04-29 18:26
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Banc of California Inc (BANC) Stock Down 3.2% but Still Overvalued -- GF Score: 73/100 | FMP Stock News | |
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On April 29, 2026, Banc of California Inc BANC shares fell 3.2% to $18.28. The stock has experienced a volatile trading period, with a 52-week range between $12.98 and $21.61.GF Value™ verdict: Current price is $18.28, which is 2.2% overvalued compared to the GF Value™ of $17.89.GF Score™: 73/100, indicating an above-average overall rating.Most notable signal: Insider activity shows a significant sell-off, with insiders selling $644.9M in the last 3 months. Is BANC Overvalued or Undervalued? The current trading price of Banc of California Inc BANC at $18.28 is slightly above the GF Value™ estimate of $17.89, indicating that the stock is 2.2% overvalued. The GF Valuation label suggests that BANC is fairly valued, which means that the stock's current price does not present a significant margin of safety for prospective investors. As the price is above the intrinsic value, there is a risk associated with entering a position at this level, as the stock may face downward pressure if market conditions shift or if the company fails to meet growth expectations. GF Value™ is GuruFocus' proprietary measure of intrinsic value, calculated from historical trading multiples, past business growth, and future performance estimates. Given that the stock is overvalued, investors may want to exercise caution and consider potential volatility in the near term, especially in light of the recent price decline. How Does BANC's Valuation Compare to Its History? Metric Current Historical P/E (TTM) 13.9x 16.4x Forward P/E 10.7x N/A Banc of California's current P/E (TTM) of 13.9x is 15% below its 5-year median P/E of 16.4x. The forward P/E of 10.7x also suggests that the stock may be trading below its historical valuation metrics. This P/E analysis aligns with the GF Value™ verdict, further reaffirming the idea that BANC is overvalued at its current price level. What Does BANC's GF Score™ Tell Us? Metric Rating GF Score™ 73 Financial Strength 3/10 Profitability 4/10 Growth 6/10 Valuation 7/10 Momentum 10/10 The GF Score™ of 73/100 indicates that Banc of California has a strong momentum rank of 10/10, suggesting that the stock has recently shown positive price movement. However, its financial strength is rated at only 3/10, which is a concern for long-term stability. The profitability rank of 4/10 and growth rank of 6/10 indicate that while there is some potential for growth, the overall financial health of the company is not robust. Investors should weigh these factors carefully when considering BANC as a part of their portfolio. What Are Insiders Doing with BANC Stock? Recent insider activity for Banc of California Inc reveals a significant disparity in buying and selling. Insiders have sold $644.9M worth of shares while only purchasing $0.3M in the last three months. This pattern of selling may suggest a lack of confidence among insiders regarding the stock's future performance, which could be a red flag for potential investors. Such a high volume of sales compared to minimal purchases indicates that insiders may believe the stock is currently overvalued or that they expect a downturn in performance. What This Means for Investors Based on the GF Value™ assessment, Banc of California Inc BANC is considered overvalued at its current price of $18.28. The stock's price is above the intrinsic value, which could expose investors to potential risks if market conditions change or if the company fails to deliver on growth expectations. For the complete analysis, visit the Banc of California Inc BANC stock page. You can also explore the GF Value™ page for detailed valuation methodology, or use the GuruFocus Stock Screener to find similar opportunities. Frequently Asked Questions What is BANC's GF Score™? BANC's GF Score™ is 73/100, indicating that it has above-average potential based on various performance metrics. Is BANC overvalued or undervalued? Banc of California Inc is currently overvalued according to the GF Value™ assessment, with a current price of $18.28 compared to a GF Value™ of $17.89. What is BANC's P/E ratio? BANC's P/E (TTM) ratio is 13.9x, which is 15% below its 5-year median P/E of 16.4x, suggesting it is trading below its historical valuation metrics. This stock alert was generated using automated technology and GuruFocus financial data to provide readers with timely and accurate market reporting. This content was reviewed by GuruFocus editorial team prior to publication. Please send any questions or comments about this story to [email protected]. |
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2026-06-12 11:53
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2026-05-08 06:05
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Banc of California, Inc. Announces Quarterly Dividends | FMP Stock News | |
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-LOS ANGELES--(BUSINESS WIRE)--Banc of California, Inc. (the “Company”) (NYSE: BANC) announced today that its Board of Directors declared a quarterly cash dividend of $0.12 per share on its outstanding common stock. The dividend will be payable July 1, 2026, to stockholders of record as of June 15, 2026. The Board of Directors also declared a quarterly cash dividend of $0.4845 per depositary share on its 7.75% Fixed Rate Non-Cumulative Perpetual Preferred Stock, Series F. The dividend will be payable June 1, 2026, to stockholders of record as of May 21, 2026. The Series F depositary shares are traded on the New York Stock Exchange under the “Banc/PF” symbol. The Company maintains a Dividend Reinvestment Plan (DRIP) which allows common stockholders to automatically acquire common shares at a 3% discount from the applicable market price. All registered common stockholders with holdings maintained at the Company’s transfer agent, Computershare, are eligible to participate in the DRIP program. For more information on the Company’s DRIP program, please contact Investor Relations at [email protected] or (855) 361-2262. About Banc of California, Inc. Banc of California, Inc. (NYSE: BANC) is a bank holding company with over $34 billion in assets and the parent company of Banc of California. Banc of California is one of the nation’s premier relationship-based business banks, providing banking and treasury management services to small, middle-market, and venture-backed businesses. Banc of California is the largest independent bank headquartered in Los Angeles and the third largest bank headquartered in California and offers a broad range of loan and deposit products and services through 79 full-service branches located throughout California and in Denver, Colorado, and Durham, North Carolina, as well as through regional offices nationwide. The Bank also provides full-service payment processing solutions to its clients and serves the Community Association Management industry nationwide with its technology-forward platform, SmartStreet™. The Bank is committed to its local communities by supporting organizations that provide financial literacy and job training, small business support, affordable housing, and more. Member FDIC. For more information, please visit us at www.bancofcal.com. More News From Banc of California, Inc. Back to Newsroom |
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2026-06-12 11:53
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2026-05-13 12:47
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Why Banc of California (BANC) is a Great Dividend Stock Right Now | FMP Stock News | |
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Whether it's through stocks, bonds, ETFs, or other types of securities, all investors love seeing their portfolios score big returns. But for income investors, generating consistent cash flow from each of your liquid investments is your primary focus.While cash flow can come from bond interest or interest from other types of investments, income investors hone in on dividends. A dividend is that coveted distribution of a company's earnings paid out to shareholders, and investors often view it by its dividend yield, a metric that measures the dividend as a percent of the current stock price. Many academic studies show that dividends account for significant portions of long-term returns, with dividend contributions exceeding one-third of total returns in many cases. Based in Los Angeles, Banc of California (BANC - Free Report) is in the Finance sector, and so far this year, shares have seen a price change of -3.47%. Currently paying a dividend of $0.12 per share, the company has a dividend yield of 2.58%. In comparison, the Banks - Southwest industry's yield is 1.66%, while the S&P 500's yield is 1.42%. Looking at dividend growth, the company's current annualized dividend of $0.48 is up 20% from last year. Over the last 5 years, Banc of California has increased its dividend 1 times on a year-over-year basis for an average annual increase of 16.61%. Looking ahead, future dividend growth will be dependent on earnings growth and payout ratio, which is the proportion of a company's annual earnings per share that it pays out as a dividend. Banc of California's current payout ratio is 32%, meaning it paid out 32% of its trailing 12-month EPS as dividend. Looking at this fiscal year, BANC expects solid earnings growth. The Zacks Consensus Estimate for 2026 is $1.72 per share, which represents a year-over-year growth rate of 27.41%. Investors like dividends for many reasons; they greatly improve stock investing profits, decrease overall portfolio risk, and carry tax advantages, among others. It's important to keep in mind that not all companies provide a quarterly payout. For instance, it's a rare occurrence when a tech start-up or big growth business offers its shareholders a dividend. It's more common to see larger companies with more established profits give out dividends. During periods of rising interest rates, income investors must be mindful that high-yielding stocks tend to struggle. With that in mind, BANC is a compelling investment opportunity. Not only is it a strong dividend play, but the stock currently sits at a Zacks Rank of #3 (Hold). |
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2026-06-12 11:53
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2026-05-30 11:40
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Banc Of California: Locking In A Yield Of Almost 7% For 15 Months | FMP Stock News | |
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Banc of California Series F Preferred shares offer an attractive 8.6% total return if called in September 2027. BANC's strong liquidity, solid net interest income, and manageable credit risk support continued preferred dividend payments. Redeeming BANC.PR.F in 2027 would boost common EPS by over $0.05, making the call highly likely given expensive reset terms. |
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2026-06-12 11:53
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2026-05-30 12:47
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Are You Looking for a High-Growth Dividend Stock? | FMP Stock News | |
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All investors love getting big returns from their portfolio, whether it's through stocks, bonds, ETFs, or other types of securities. However, when you're an income investor, your primary focus is generating consistent cash flow from each of your liquid investments.Cash flow can come from bond interest, interest from other types of investments, and, of course, dividends. A dividend is that coveted distribution of a company's earnings paid out to shareholders, and investors often view it by its dividend yield, a metric that measures the dividend as a percent of the current stock price. Many academic studies show that dividends make up large portions of long-term returns, and in many cases, dividend contributions surpass one-third of total returns. Banc of California (BANC - Free Report) is headquartered in Los Angeles, and is in the Finance sector. The stock has seen a price change of -1.87% since the start of the year. The banking service and lending company is currently shelling out a dividend of $0.12 per share, with a dividend yield of 2.54%. This compares to the Banks - Southwest industry's yield of 1.67% and the S&P 500's yield of 1.44%. Looking at dividend growth, the company's current annualized dividend of $0.48 is up 20% from last year. Over the last 5 years, Banc of California has increased its dividend 1 times on a year-over-year basis for an average annual increase of 16.61%. Looking ahead, future dividend growth will be dependent on earnings growth and payout ratio, which is the proportion of a company's annual earnings per share that it pays out as a dividend. Banc of California's current payout ratio is 32%, meaning it paid out 32% of its trailing 12-month EPS as dividend. Looking at this fiscal year, BANC expects solid earnings growth. The Zacks Consensus Estimate for 2026 is $1.72 per share, with earnings expected to increase 27.41% from the year ago period. From greatly improving stock investing profits and reducing overall portfolio risk to providing tax advantages, investors like dividends for a variety of different reasons. It's important to keep in mind that not all companies provide a quarterly payout. High-growth firms or tech start-ups, for example, rarely provide their shareholders a dividend, while larger, more established companies that have more secure profits are often seen as the best dividend options. Income investors have to be mindful of the fact that high-yielding stocks tend to struggle during periods of rising interest rates. With that in mind, BANC is a compelling investment opportunity. Not only is it a strong dividend play, but the stock currently sits at a Zacks Rank of #3 (Hold). |
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2026-06-12 11:53
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2026-03-26 04:17
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Terns Pharmaceuticals (NASDAQ:TERN) Sets New 12-Month High – Here’s Why | FMP Stock News | |
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Shares of Terns Pharmaceuticals, Inc. (NASDAQ: TERN - Get Free Report) reached a new 52-week high during mid-day trading on Thursday. The company traded as high as $52.98 and last traded at $52.86, with a volume of 81314600 shares trading hands. The stock had previously closed at $50.00. Trending Headlines about Terns Pharmaceuticals Here are |
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2026-06-12 11:53
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2026-03-26 05:06
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E. Ohman J or Asset Management AB Sells 81,208 Shares of Terns Pharmaceuticals, Inc. $TERN | FMP Stock News | |
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E. Ohman J or Asset Management AB lessened its position in shares of Terns Pharmaceuticals, Inc. (NASDAQ: TERN) by 79.3% in the fourth quarter, according to its most recent filing with the SEC. The firm owned 21,202 shares of the company's stock after selling 81,208 shares during the quarter. E. Ohman J or |
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2026-06-12 11:53
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2026-03-26 12:10
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Merck to Boost Oncology Pipeline With $6.7B Terns Buyout, Stock Up | FMP Stock News | |
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Key Takeaways Merck is looking to acquire Terns for $53 per share, valuing the deal at almost $6.7B equity.Terns TERN-701, a leukemia drug candidate, showed strong early clinical response rates in studies.Merck is ramping up merger and acquisition deals in recent times to offset Keytruda's 2028 patent loss. Merck (MRK - Free Report) announced that it has entered into a definitive agreement to acquire California-based cancer biotech, Terns Pharmaceuticals , for $53.00 per share in cash or an estimated equity value of $6.7 billion.The offer values the deal at about $5.7 billion after adjusting for cash. Following the announcement of the acquisition, shares of Merck were up 2.6%. Terns' stock gained 5.7% yesterday. Year to date, shares of Merck have risen 13.4% against the industry’s decrease of 4.9%. Image Source: Zacks Investment Research Shares of Terns have rallied 30.8% so far this year against the industry’s decrease of 0.6%. Image Source: Zacks Investment Research TERN Acquisition Can Boost Merck’s Cancer PipelineThe impending acquisition will add Terns’ lead candidate, TERN-701, an investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor, to Merck’s hematology/cancer pipeline. The candidate is currently being evaluated in a phase I/II study for treating certain patients with chronic myeloid leukemia (CML). Per the company, TERN-701 has shown promising results so far, with encouraging major and deep molecular response rates by week 24 in clinical studies. Based on this early data, management believes that, if successfully developed, TERN-701 could offer a differentiated treatment option for certain patients with CML. TERN-701 has received an Orphan Drug designation from the FDA for treating CML. The acquisition is expected to be closed in the second quarter of 2026, subject to customary closing conditions. It is likely to further strengthen and diversify MRK’s oncology pipeline. The deal is expected to lead to a charge of around $5.8 billion, or roughly $2.35 per share, which will be reflected in Merck’s second-quarter and full-year 2026 GAAP and non-GAAP results. MRK Eyes M&A Deal to Offset Keytruda’s Upcoming LOEMerck has been on an acquisition spree in recent times, as it faces looming patent expiration of its blockbuster drug, PD-L1 inhibitor Keytruda, in 2028. Keytruda accounts for more than 50% of the company’s pharmaceutical sales. Merck acquired Cidara Therapeutics for $9.2 billion in January 2026. The acquisition added CDTX’s lead pipeline candidate, CD388, a first-in-class long-acting, strain-agnostic antiviral agent, currently being evaluated in late-stage studies for the prevention of seasonal influenza in individuals at higher risk of complications. Last year, Merck acquired Verona Pharma for around $10 billion, which added the latter’s lead drug Ohtuvayre, a novel, first-in-class maintenance treatment for chronic obstructive pulmonary disease, with multibillion-dollar commercial potential. Ohtuvayre's commercial launch is off to a solid start, backed by strong growth in new patient starts and total patients treated. Merck believes new products like Ohtuvayre could drive long-term growth and help offset the revenue gap expected from Keytruda’s upcoming loss of exclusivity in 2028. Merck acquired cancer biotech, Harpoon Therapeutics, in 2024. MRK & TERN’s Zacks RankMerck currently carries a Zacks Rank #3 (Hold), while Terns has a Zacks Rank #2 (Buy). Key PickA top-ranked stock in the biotech sector is Amarin (AMRN - Free Report) , carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Amarin’s 2026 loss per share have narrowed from $7.32 to $6.36, while the same for 2027 have narrowed from $5.97 to $4.64. AMRN shares have risen 5.2% in the year-to-date period. Amarin’s earnings beat estimates in three of the trailing four quarters and missed on the remaining occasion, with the average surprise being 51.29%. |
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2026-06-12 11:53
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2026-03-27 08:04
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Here Are Friday’s Top Wall Street Analyst Research Calls: Brown-Forman, Chord Energy, Emerson Electric, FuboTV, Genmab, Honeywell, Knight-Swift, Wix.Com, and More | FMP Stock News | |
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This post may contain links from our sponsors and affiliates, and Flywheel Publishing may receive compensation for actions taken through them.© Bet_Noire / iStock via Getty Images Pre-Market Stock Futures: Futures are trading lower as we prepare to end another up-and-down week, and, as we mentioned before, it all depends on the status of the war with Iran and the price of oil on any given day. Those two items have dictated the direction of stocks, bonds, precious metals, and crypto since the war started. All of the major indices finished deep in the red, with the Nasdaq getting absolutely pounded, closing down 2.38% at 21,408, while the S&P 500 finished the session down 1.74% at 6,477. The small-cap Russell 2000 closed Thursday at 2,491, down 1.75%. The venerable Dow Jones Industrials held up the best, closing down 1.01% at 45,960. Selling accelerated into the close, and with the first quarter ending soon, this could get ugly for the next few sessions. Treasury Bonds: Sellers showed up right on cue for the Treasury bond market, just like they have every other day when stocks trade down recently. Worries over rising inflation and the potential for the Federal Reserve to raise rates later this year have encouraged sellers. The 30-year bond finished trading Thursday at 4.94%, while the benchmark 10-year note was last seen at 4.42%. With hopes for a ceasefire receding, we could be in for a tough stretch. Oil and Gas: Needless to say, prices across the energy complex rose on Thursday as all the issues we mentioned above came into play. While the President said Iran allowed 10 tankers through the Strait of Hormuz, the reality is that when 20% of the world’s oil supply passes through a contested point and is slowed to a crawl, prices will remain higher. Brent Crude closed Thursday at $107.50, up 5.21%, while West Texas Intermediate closed at $94.44, up 4.56%. Natural gas closed at $2.97, up 0.71%. Gold: As expected, and discussed ad nauseam, the precious metals, equity, debt, and the crypto silos all joined in lockstep to sell off in a big way on Thursday. We noted earlier this week that gold had traded lower for nine straight sessions before finally breaking the streak on Tuesday. It may have started a new one on Thursday, with Gold closing the day down 2.79% at $4,379, while Silver finished the day down 4.29% at $68.08. Crypto: Cryptocurrency markets fell sharply on Thursday as Bitcoin slipped below $70,000, with the broader digital asset market caught in a broader sell-off. The pullback came as surging oil prices and declining U.S. stock futures pushed investors away from riskier assets, while geopolitical tensions added to the cautious mood. At AM, Bitcoin traded at $66,680, while Ethereum traded at $1,995. 24/7 Wall St. reviews dozens of analyst research reports daily to identify new investment ideas for both investors and traders. Some of these daily analyst calls cover stocks to buy. Other calls cover stocks to sell or avoid. Remember that no single analyst call should ever be used as a basis to buy or sell a stock. Here are some of the top Wall Street analyst upgrades, downgrades, and initiations seen on Friday, March 27, 2026. Upgrades: Argan Inc. (NYSE: AGX) was upgraded to Overweight from Neutral at JPMorgan, which lifted the target price for the shares to $550 from $370. Brown-Forman Corporation (NYSE: BF-B) | BF-B Price Prediction was upgraded to Neutral from Underweight at JP Morgan, which bumped the target price for the spirits giant to $27 from $25. Chord Energy Corp. (NASDAQ: CHRD) was raised to Overweight from Neutral at Morgan Stanley, which boosted the target price for the shares to $168 from $114. Knight-Swift Transportation Holdings Inc. (NYSE: KNX) was upgraded to Outperform from In line at Evercore ISI, which nudged the target price for the trucking giant to $65 from $61. Teleflex Incorporated (NYSE: TFX) was upgraded to Outperform from Neutral at Raymond James, with a $128 target price objective. Downgrades: Masimo Corp. (NASDAQ: MASI) was downgraded to Market Perform from Outperform at Raymond James. The shares are trading near the $180 level, where the company is being acquired. Terns Pharmaceuticals Inc. (NASDAQ: TERN) was downgraded to Market Perform from Overweight at BMO Capital, with a $53 target price. Upstream Bio, Inc. (NASDAQ: UPB) was downgraded to In line from Outperform at Evercore ISI, which slashed the target price for the stock to $15 from $40. Wix.com Ltd. (NASDAQ: WIX) was downgraded to Underweight from Neutral at JPMorgan, which cut the target price for the stock to $91 from $114. Initiations: Emerson Electric Company (NYSE: EMR) was initiated with a Market Perform rating at BMO Capital, which has a $150 target price for the stock. FuboTV Inc. (NYSE: FUBO) was initiated with a Buy rating at B. Reilly, with an $18 target price. Genmab A/S (NASDAQ: GMAB) was initiated with an Outperform rating at Wolfe Research, with a $32 target price. Honeywell International Inc. (NYSE: HON) was initiated with an Overweight rating at BMO Capital with a $273 target price. Thermo Fisher Scientific Inc. (NYSE: TM) was started with a Buy rating at DZ Bank, which has set a $610 target price for the shares. |
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2026-06-12 11:53
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2026-03-31 08:14
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Here Are Tuesday’s Top Wall Street Analyst Research Calls: Arista Networks, Block, Colgate-Palmolive, Digital Realty, Emerson Electric, MiniMed, Shake Shack, and More | FMP Stock News | |
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© Chaay_Tee / iStock via Getty ImagesPre-Market Stock Futures: Futures are trading higher this morning after reports are circulating that President Trump wants to end the war soon. This comes after Monday’s session, which saw three of the four major indices close lower, while oil traded above $100 for the first time since the summer of 2022. Conflicting headlines flew around; some were very positive, and some were more negative. When it was all said and done on Monday, only the venerable Dow Jones Industrial finished the day positive, closing up 0.11% at 45,216. The small-cap Russell 2000 took the biggest hit to start the holiday-shortened trading week, closing down 1.46% at 2,414, while the Nasdaq finished the day at 20,794, down by 0.73%, and the S&P 500 was last seen at 6,343, down 0.39%. Investors need to be careful, as all major indices are in or approaching correction territory and could be poised for a sharp decline if the war escalates. Treasury Bonds: After choppy trading last week, buyers returned in full force on Monday, as yields were lower across the entire curve amid a safe-haven trade back on in a big way. The combination of inflation returning as an issue, the potential for no rate cuts, and the possibility of a rate increase, combined with geopolitical worries, sent prices higher and yields lower. The 30-year-long bond finished the session at 4.91%, while the benchmark 10-year note closed Monday at 4.35%. Oil and Gas: West Texas Intermediate, as we noted, closed over the $100 level for the first time in almost four years, finishing the session Monday at $105, up 5.40%, while Brent Crude closed at $114.60, which was higher by 1.81%. The escalation of hostilities, with the Houthis joining Iran’s side, and concerns across the entire energy complex that distribution, along with exploration and production, will be in serious jeopardy in the Middle East, are issues investors are facing. Natural gas took a beating Monday, closing down 4.86% at $2,87. Gold: The precious metal markets, which had been in lockstep with every other asset class that traded down over the last month, are holding steady at current support levels. Current pricing reflects ongoing upward momentum, supported by market attempts to find a footing amid geopolitical tensions and navigate between high inflation fears and potential diplomatic developments. Gold closed trading on Monday at $4,510, up 0.38%, while Silver was last seen at $70.22, up 0.50%. Crypto: Crypto markets traded higher on Monday, briefly staging a relief rally after a bruising stretch that had left sentiment washed out and many crypto-linked equities down roughly 60% from recent highs. Bitcoin steadied in the upper-$66,000 to upper-$67,000 range throughout much of the Monday session, while Ethereum climbed as traders returned to beaten-down names and short-covering fueled the rebound. The move was helped by some easing geopolitical anxiety, albeit conflicting, and a modest improvement in broader risk appetite, which gave digital assets room to bounce after several sessions of macro-driven selling. At 8 AM EDT, Bitcoin was trading at $66,660, while Ethereum was trading at $2,042. 24/7 Wall St. reviews dozens of analyst research reports daily to identify new investment ideas for both investors and traders. Some of these daily analyst calls cover stocks to buy. Other calls cover stocks to sell or avoid. Remember that no single analyst call should ever be used as a basis to buy or sell a stock. Here are some of the top Wall Street analyst upgrades, downgrades, and initiations seen on Tuesday, March 31, 2026. Upgrades: Amphenol Corp. (NYSE: APH | APH Price Prediction) was assumed with a Buy rating from Hold at Jefferies, which trimmed the target price for the stock to $145 from $150. Emerson Electric Company (NYSE: EMR) was assumed with a Buy rating from Hold at Jefferies, which raised the target price for the stock to $175 from $160. Highwoods Properties Inc. (NYSE: HIW) was raised to Equal Weight from Underweight at Morgan Stanley, which nudged the target price down to $23 from $24. Shake Shack Inc. (NYSE: SHAK) was upgraded to Neutral from Underperform at Bank of America, which raised the price target to $101 from $88. Western Digital Corp. (NASDAQ: WDC) was upgraded to Outperform from Market Perform at Bernstein, which doubled the price target for the tech giant to $340 from $170. Downgrades: Colgate-Palmolive Company (NYSE: CL) was downgraded to Hold from Buy at TD Cowen, which lowered the target price for the consumer staples giant to $85 from $96. Lincoln Electric Holdings Inc. (NASDAQ: LECO) was downgraded to Hold from Buy at Jefferies, which cut the target price to $280 from $350. Rockwell Automation Inc. (NYSE: ROK) was downgraded to Hold from Buy at Jefferies, which slashed the target price for the shares to $380 from $490. Terns Pharmaceuticals Inc. (NASDAQ: TERN) was cut to Hold from Buy at Truist, with a $523 target price objective. Vertiv Holdings Co. (NYSE: VRT) was downgraded to Hold from Buy at Jefferies, which lowered the target price to $260 from $280. Initiations: Arista Networks Inc. (NYSE: ANET) was started with a Buy rating at Truist, which has set a $161 target price for the stock. Block Inc. (NYSE: XYZ) was started with a Buy rating at Loop Capital with a $62 target price. Digital Realty Trust Inc. (NYSE: DLR) was initiated with a Buy rating at Truist, which bumped the target price for the stock to $207 from $202. MiniMed Group Inc. (NASDAQ: MMED) was started with an Overweight rating at Morgan Stanley with a $19 target price. In comparison, Mizuho began covering the stock with an Outperform rating with a $21 target price. Citigroup initiated coverage with a Buy rating and a $23 target price, while Wells Fargo has an Overweight rating with a $26 target price. The company was a recent IPO NiSource Inc. (NYSE: NI) was initiated with an Overweight rating at KeyBanc, which has a $52 target price objective. |
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Terns Pharmaceuticals Reports Inducement Grants to New Employees Under Nasdaq Listing Rule 5635(C)(4) | FMP Stock News | |
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April 02, 2026 16:05 ET | Source: Terns Pharmaceuticals, Inc.FOSTER CITY, Calif., April 02, 2026 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage oncology company, today announced that it has granted as of April 1, 2026 equity inducement awards to three new employees under the terms of the 2022 Employment Inducement Award Plan, as amended. The equity awards were approved by the Compensation Committee of the Company’s Board of Directors in accordance with Nasdaq Listing Rule 5635(c)(4) and were made as a material inducement to the employees’ acceptance of employment with Terns. The Company granted 23,316 restricted stock units (the “RSUs”), in the aggregate, of Terns common stock to the new employees. The RSUs vest over four years, subject to the employees’ continued service through the applicable vesting dates. About Terns Pharmaceuticals Terns Pharmaceuticals is a clinical-stage oncology company reimagining known biology to deliver high impact medicines. Our lead program, TERN-701, is a highly selective, oral, allosteric BCR-ABL inhibitor with a potentially best-in-disease profile that could meaningfully improve upon the efficacy, safety and convenience of existing treatments for chronic myeloid leukemia. For more information, please visit: www.ternspharma.com. Contacts for Terns Investors Justin Ng [email protected] Media Jenna Urban CG Life [email protected] |
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Capricorn Fund Managers Ltd Takes $6.12 Million Position in Terns Pharmaceuticals, Inc. $TERN | FMP Stock News | |
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Posted by Defense World Staff on Apr 6th, 2026Capricorn Fund Managers Ltd bought a new stake in shares of Terns Pharmaceuticals, Inc. (NASDAQ:TERN – Free Report) during the 4th quarter, according to its most recent disclosure with the Securities and Exchange Commission. The institutional investor bought 151,436 shares of the company’s stock, valued at approximately $6,118,000. Terns Pharmaceuticals makes up approximately 1.5% of Capricorn Fund Managers Ltd’s holdings, making the stock its 27th largest holding. Capricorn Fund Managers Ltd owned approximately 0.17% of Terns Pharmaceuticals as of its most recent filing with the Securities and Exchange Commission. A number of other hedge funds and other institutional investors also recently added to or reduced their stakes in the business. FNY Investment Advisers LLC purchased a new stake in shares of Terns Pharmaceuticals during the fourth quarter worth about $80,000. Tema Etfs LLC purchased a new position in shares of Terns Pharmaceuticals in the 4th quarter valued at approximately $414,000. SG Americas Securities LLC acquired a new stake in Terns Pharmaceuticals in the 4th quarter worth approximately $1,772,000. GAMMA Investing LLC boosted its stake in Terns Pharmaceuticals by 762.4% in the 4th quarter. GAMMA Investing LLC now owns 871 shares of the company’s stock worth $35,000 after purchasing an additional 770 shares in the last quarter. Finally, JPMorgan Chase & Co. grew its position in Terns Pharmaceuticals by 90.6% during the 3rd quarter. JPMorgan Chase & Co. now owns 682,708 shares of the company’s stock worth $5,127,000 after purchasing an additional 324,502 shares during the last quarter. 98.26% of the stock is currently owned by hedge funds and other institutional investors. Insider Activity In other Terns Pharmaceuticals news, insider Emil Kuriakose sold 942 shares of the stock in a transaction that occurred on Wednesday, April 1st. The stock was sold at an average price of $52.75, for a total transaction of $49,690.50. Following the transaction, the insider owned 105,673 shares in the company, valued at approximately $5,574,250.75. This represents a 0.88% decrease in their ownership of the stock. The sale was disclosed in a document filed with the SEC, which can be accessed through this hyperlink. Also, CEO Amy L. Burroughs sold 14,583 shares of the stock in a transaction that occurred on Monday, March 16th. The stock was sold at an average price of $46.71, for a total value of $681,171.93. Following the transaction, the chief executive officer owned 288,976 shares in the company, valued at $13,498,068.96. This represents a 4.80% decrease in their position. Additional details regarding this sale are available in the official SEC disclosure. Over the last three months, insiders have sold 98,857 shares of company stock worth $3,850,896. Corporate insiders own 1.50% of the company’s stock. Analysts Set New Price Targets A number of research firms have issued reports on TERN. Jefferies Financial Group reaffirmed a “buy” rating and issued a $70.00 price target on shares of Terns Pharmaceuticals in a report on Wednesday, December 10th. HC Wainwright reissued a “neutral” rating and set a $53.00 price objective (down from $60.00) on shares of Terns Pharmaceuticals in a report on Wednesday, March 25th. TD Cowen downgraded Terns Pharmaceuticals from a “buy” rating to a “hold” rating and set a $53.00 target price on the stock. in a research report on Thursday, March 26th. BMO Capital Markets lowered Terns Pharmaceuticals from a “strong-buy” rating to a “hold” rating in a research note on Thursday, March 26th. Finally, Wall Street Zen cut Terns Pharmaceuticals from a “hold” rating to a “sell” rating in a research report on Saturday, March 21st. One equities research analyst has rated the stock with a Strong Buy rating, five have issued a Buy rating, seven have issued a Hold rating and one has issued a Sell rating to the company. According to MarketBeat.com, the company currently has a consensus rating of “Hold” and an average target price of $56.30. View Our Latest Stock Analysis on Terns Pharmaceuticals Terns Pharmaceuticals Price Performance Shares of NASDAQ TERN opened at $52.72 on Monday. The stock has a market capitalization of $6.08 billion, a price-to-earnings ratio of -51.18 and a beta of -0.37. Terns Pharmaceuticals, Inc. has a 12 month low of $1.87 and a 12 month high of $53.19. The firm’s 50 day simple moving average is $42.96 and its 200-day simple moving average is $30.97. Terns Pharmaceuticals (NASDAQ:TERN – Get Free Report) last posted its earnings results on Thursday, April 2nd. The company reported ($0.24) earnings per share (EPS) for the quarter, beating the consensus estimate of ($0.30) by $0.06. Analysts anticipate that Terns Pharmaceuticals, Inc. will post -1.19 earnings per share for the current fiscal year. Terns Pharmaceuticals Company Profile (Free Report) Terns Pharmaceuticals, Inc is a clinical‐stage biopharmaceutical company focused on developing oral small‐molecule therapies for the treatment of chronic liver diseases and other serious conditions. The company’s research and development efforts center on novel mechanisms of action designed to address the underlying causes of progressive liver disorders, including inflammation, fibrosis and metabolic dysregulation. By advancing targeted compounds that can be administered orally, Terns aims to offer patients more convenient and effective treatment options compared to injectable or biologic therapies. The company’s pipeline features several candidates in various stages of preclinical and clinical evaluation. Featured Stories Five stocks we like better than Terns Pharmaceuticals Receive News & Ratings for Terns Pharmaceuticals Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Terns Pharmaceuticals and related companies with MarketBeat.com's FREE daily email newsletter. « PREVIOUS HEADLINECapricorn Fund Managers Ltd Acquires Shares of 50,000 Astera Labs, Inc. $ALAB NEXT HEADLINE »Capricorn Fund Managers Ltd Acquires Shares of 25,000 Norfolk Southern Corporation $NSC |
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Shareholder Alert: Ademi LLP investigates whether Terns Pharmaceuticals Inc. is obtaining a Fair Price for Public Shareholders | FMP Stock News | |
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MILWAUKEE, April 07, 2026 (GLOBE NEWSWIRE) -- Ademi LLP is investigating Terns (NASDAQ: TERN) for possible breaches of fiduciary duty and other violations of law in its recently announced transaction with Merck.Click here to learn how to join our investigation and obtain additional information or contact us at [email protected] or toll-free: 866-264-3995. There is no cost or obligation to you. In the transaction, Terns stockholders will receive $53.00 per share in cash, representing an equity value of approximately $6.7 billion or $5.7 billion net of acquired cash. Terns insiders will receive substantial benefits as part of change of control arrangements. The transaction agreement unreasonably limits competing transactions for Terns by imposing a significant penalty if Terns accepts a competing bid. We are investigating the conduct of the Terns board of directors, and whether they are fulfilling their fiduciary duties to all shareholders. We specialize in shareholder litigation involving buyouts, mergers, and individual shareholder rights. For more information, please feel free to call us. Attorney advertising. Prior results do not guarantee similar outcomes. Contacts Ademi LLP Guri Ademi Toll Free: (866) 264-3995 Fax: (414) 482-8001 |
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Merck Begins Tender Offer to Acquire Terns Pharmaceuticals, Inc. | FMP Stock News | |
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RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, is commencing today, through a subsidiary, a cash tender offer to purchase all outstanding shares of common stock of Terns Pharmaceuticals, Inc. (“Terns”) (Nasdaq: TERN). On March 25, 2026, Merck announced that it had entered into a definitive agreement to acquire Terns.Upon the successful closing of the tender offer, stockholders of Terns will receive $53.00 net in cash for each share of Terns common stock validly tendered and not validly withdrawn in the offer, without interest and less any applicable tax withholding. Following the purchase of shares in the tender offer, Terns will become a wholly owned subsidiary of Merck. Merck has filed today with the U.S. Securities and Exchange Commission (the “SEC”) a tender offer statement on Schedule TO, which provides the terms of the tender offer. Additionally, Terns has filed with the SEC a solicitation/recommendation statement on Schedule 14D-9 that includes the recommendation of the Terns board of directors that their stockholders accept the tender offer and tender their shares. The tender offer will expire one minute following 11:59 p.m., Eastern Time, on May 4, 2026, unless extended in accordance with the merger agreement and the applicable rules and regulations of the SEC. The closing of the tender offer is subject to certain conditions, including the tender of shares representing more than 50% of the total number of Terns’ outstanding shares, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and other customary conditions. The transaction is expected to close in the second quarter of 2026. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Important Information About the Tender Offer This release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Terns or any other securities, nor is it a substitute for the tender offer materials described herein. A tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, has been filed by Merck, Merck Sharp & Dohme LLC and Thailand Merger Sub, Inc. with the SEC, and a solicitation/recommendation statement on Schedule 14D-9 has been filed by Terns with the SEC. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SECURITIES, INCLUDING THE TERMS AND CONDITIONS OF THE OFFER. Investors and security holders may obtain a free copy of the Offer to Purchase, the related Letter of Transmittal, other tender offer documents and the Solicitation/Recommendation Statement (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the tender offer, which will be named in the tender offer statement. In addition, Merck and Terns file annual, quarterly and current reports and other information with the SEC, which are available to the public from commercial document-retrieval services and at the SEC’s website at www.sec.gov. Copies of the documents filed with the SEC by Merck may be obtained at no charge on Merck’s internet website at www.merck.com or by contacting Merck at 126 East Lincoln Avenue P.O. Box 2000, Rahway, NJ 07065 USA, or by phone at (908) 740-4000. Copies of the documents filed with the SEC by Terns may be obtained at no charge from Terns’ internet website at www.ternspharma.com or by contacting Terns at 1065 East Hillsdale Blvd., Suite 100, Foster City, CA 94404 or (650)-525-5535 Ext.101. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expects,” “intends,” “believes,” “may,” “plan” or “will.” Forward-looking statements in this release include, but are not limited to, statements related to the ability of the company and Terns to complete the transactions contemplated by the transaction agreement, including the parties’ ability to satisfy the conditions to the consummation of the transaction contemplated thereby, statements about the expected timetable for completing the transaction, the company’s and Terns’ beliefs and expectations and statements about the benefits sought to be achieved in the company’s proposed acquisition of Terns, the potential effects of the acquisition on both the company and Terns, and the possibility of any termination of the transaction agreement. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Terns’ clinical studies and other risks related to clinical development, delays in or unanticipated action by regulatory authorities, risks related to government contracts, having to use cash in ways other than as expected and other risks, uncertainties associated with Terns’ business in general; the risk that competing offers or acquisition proposals will be made; the possibility that various conditions to the consummation of the proposed transaction contained in the transaction agreement may not be satisfied or waived (including, but not limited to, the failure to obtain a sufficient number of tendered shares from Terns’ stockholders); the effects of disruption from the transactions contemplated by the transaction agreement and the impact of the announcement and pendency of the transactions on Terns’ business; the risk that stockholder litigation in connection with the transaction may result in significant costs of defense, indemnification and liability; general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the SEC available at the SEC’s Internet site (www.sec.gov). More News From Merck & Co., Inc. |
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Merck Lowered Terns Pharmaceuticals Offer Price After Trial Data Review | FMP Stock News | |
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The deal consideration is $53.00 per share in cash for an approximate equity value of $6.7 billion.Updated Trial Data Influences Merck NegotiationsDuring deal negotiations, Merck decided to lower its offer price after seeing updated clinical data for Terns' lead drug TERN-701, according to SEC filings on Tuesday. As per the documents, Merck submitted a non-binding proposal of $61.00 per share in February. Later, Merck received updated clinical data from Terns' ongoing CARDINAL trial of TERN-701 from Terns management, which was previously requested by Merck. That same week, Merck received from Terns clinical data generated under Terns' exclusive option and license agreement with Hansoh (Shanghai) Healthtech Co., Ltd. and Jiangsu Hansoh Pharmaceutical Group Company Ltd. In December 2025, Terns presented updated and expanded data at the ASH presentation from its ongoing CARDINAL trial of TERN-701 in patients with previously treated Chronic Myeloid Leukemia (CML). The SEC filings did not share the exact clinical data update, though they revealed that the "MMR achievement rate was lower, potentially due to more patients being pre-treated with asciminib in the evaluable population." Novartis AG (NYSE:NVS) markets Asciminib under the Scemblix name. The filing noted that the new rate "stayed within Terns' disclosed confidence interval after the ASH Annual Meeting, with no overlap with the asciminib interval." Competing Bid Withdrawn Over Data ConcernsIn December 2025, Party C, a large pharmaceutical company, had made a $58 per-share offer for Terns. But later, it increased the offer to $61 per share plus $9 per share in a contingent value right if TERN-701 received FDA approval for CML. Party C withdrew from the discussions because it decided the updated TERN-701 data were "more nuanced than Party C had previously understood and that Party C did not view TERN-701 as sufficiently differentiated or sufficiently de-risked to proceed," according to the Tuesday SEC filing. Merck downsized its offer to $50 per share and said that the "MMR achievement rate for TERN-701 would likely be at the low end of the range discussed by Terns management," the SEC filing noted. SEC filing also highlighted that Merck still viewed the data as "compelling relative to asciminib and therefore had continued enthusiasm to proceed with a transaction." MRK Stock Price Activity: Merck shares were down 2.09% at $118.33 at the time of publication on Tuesday, according to Benzinga Pro data. Image via Shutterstock Market News and Data brought to you by Benzinga APIs © 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved. To add Benzinga News as your preferred source on Google, click here. |
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Why Terns Pharmaceuticals Stock Rocked the Market in March | FMP Stock News | |
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Terns Pharmaceuticals (TERN +0.00%) had a more memorable March than a great many other companies on U.S. stock exchanges. That's largely because it agreed to be bought out by a much larger peer, and the deal's premium helped crank Terns' share price more than 25% higher over the month.Billions for a buyout That earth-shaking event occurred on March 25. In a joint press release, Terns and global pharmaceutical giant Merck announced a definitive agreement under which Merck (via a subsidiary) will acquire the smaller company for $53 per share in cash. The pair said this represents a 42% premium over Terns' 90-day volume-weighted average price. All told, wrote the companies, the deal is worth around $6.7 billion. Image source: Getty Images. The jewel in this crown is Tern's lead drug candidate, TERN-701. This medication is intended to treat certain patients with chronic myeloid Leukemia (CML) and has shown efficacy in clinical trials. Currently, it's being evaluated in a phase 1/2 trial and has received the Food and Drug Administration's (FDA) Orphan Drug Designation as a potential CML treatment. Terns and Merck quoted the latter's CEO, Robert Davis, as saying that the acquisition "further diversifies and strengthens our position in oncology as we continue to look for opportunities to broaden our portfolio into other therapeutic areas." The boards of directors of the two companies have approved the agreement. It's subject to a majority of Terns' shareholders tendering their stock, though given the well-in-the-double-digits premium, this is very likely. It's also subject to approval by the relevant regulatory bodies. Terns and Merck expect the deal to close in the current quarter. Some Terns followers felt Merck is getting quite a bargain. Just after the transaction was announced, Truist Securities analyst Kripa Devarakonda published a quick-reaction update on the biotech. She wrote that the agreement was a "steal" for the buyer, as she feels that if and when it comes to market, TERN-701 can be a powerful revenue driver. Today's Change ( 0.00 %) $ 0.00 Current Price $ 0.00 Time to let go I feel this acquisition is beneficial for both the buyer and seller. Merck, which will soon begin losing patent protection from its star drug Keytruda, gets a robust asset that bolsters its oncology efforts. At the same time, Terns' shareholders receive a very healthy premium -- despite what some commenters might think -- for unloading their stock. With that anticipated closing date looming sooner rather than later, the story of Terns as an independent company is, at least for now, over. Investors who haven't done so yet should tender their shares, as there's almost no reason to hold on to them. Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Merck and Truist Financial. The Motley Fool has a disclosure policy. |
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Are WSR, TERN, RLYB, DAWN Obtaining Fair Deals for their Shareholders? | FMP Stock News | |
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Insiders may stand to receive substantial financial benefits not available to ordinary shareholders.The proposed transactions may contain terms that could limit superior competing offers. Shareholders are encouraged to contact the firm to discuss their rights and options at no cost or obligation. We would handle any matter on a contingent fee basis, whereby you would not be responsible for out-of-pocket payment of our legal fees or expenses. , /PRNewswire/ -- Halper Sadeh LLC, an investor rights law firm, is investigating the following companies for potential violations of the federal securities laws and/or breaches of fiduciary duties to shareholders relating to: Whitestone REIT (NYSE: WSR)'s sale to Ares Management Corporation for $19.00 per share or unit. If you are a Whitestone shareholder, click here to learn more about your legal rights and options. Terns Pharmaceuticals, Inc. (NASDAQ: TERN)'s sale to Merck for $53.00 per share in cash. If you are a Terns shareholder, click here to learn more about your rights and options. Rallybio Corporation (NASDAQ: RLYB)'s merger with Candid Therapeutics, Inc. Upon completion of the proposed transaction, Rallybio shareholders are expected to own approximately 3.65% of the combined company. If you are a Rallybio shareholder, click here to learn more about your rights and options. Day One Biopharmaceuticals, Inc. (NASDAQ: DAWN)'s sale to Servier for $21.50 per share in cash. If you are a Day One shareholder, click here to learn more about your rights and options. On behalf of shareholders, Halper Sadeh LLC may seek increased consideration, additional disclosures and information, or other relief and benefits. Halper Sadeh LLC represents investors all over the world who have fallen victim to securities fraud and corporate misconduct. Our attorneys have been instrumental in implementing corporate reforms and recovering millions of dollars on behalf of defrauded investors. Attorney Advertising. Prior results do not guarantee a similar outcome. Contact Information: Halper Sadeh LLC Daniel Sadeh, Esq. Zachary Halper, Esq. One World Trade Center 85th Floor New York, NY 10007 (212) 763-0060 [email protected] [email protected] https://www.halpersadeh.com SOURCE Halper Sadeh LLP |
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Terns Pharmaceuticals Investor Alert: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Terns Pharmaceuticals, Inc. - TERN | FMP Stock News | |
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-NEW YORK & NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Terns Pharmaceuticals, Inc. (NasdaqGS: TERN) to Merck (NYSE: MRK). Under the terms of the proposed transaction, shareholders of Terns will receive $53.00 in cash for each share of Terns that they own. KSF is seeking to determine whether this consideration and the process that led to it are adequate, or whether the consideration undervalues the Company. If you believe that this transaction undervalues the Company and/or if you would like to discuss your legal rights regarding the proposed sale, you may, without obligation or cost to you, e-mail or call KSF Managing Partner Lewis S. Kahn ([email protected]) toll free at any time at 855-768-1857, or visit https://www.ksfcounsel.com/cases/nasdaqgs-tern/ to learn more. Please note that the transaction is structured as a tender offer, such that time may be of the essence. To learn more about KSF, whose partners include the Former Louisiana Attorney General, visit www.ksfcounsel.com. CONNECT WITH US: Facebook || Instagram || YouTube || TikTok || LinkedIn More News From Kahn Swick & Foti, LLC Back to Newsroom |
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Are TERN, SLNO, WSR Obtaining Fair Deals for their Shareholders? | FMP Stock News | |
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Insiders may stand to receive substantial financial benefits not available to ordinary shareholders.The proposed transactions may contain terms that could limit superior competing offers. Shareholders are encouraged to contact the firm to discuss their rights and options at no cost or obligation. We would handle any matter on a contingent fee basis, whereby you would not be responsible for out-of-pocket payment of our legal fees or expenses. , /PRNewswire/ -- Halper Sadeh LLC, an investor rights law firm, is investigating the following companies for potential violations of the federal securities laws and/or breaches of fiduciary duties to shareholders relating to: Terns Pharmaceuticals, Inc. (NASDAQ: TERN)'s sale to Merck for $53.00 per share in cash. If you are a Terns shareholder, click here to learn more about your rights and options. Soleno Therapeutics, Inc. (NASDAQ: SLNO)'s sale to Neurocrine Biosciences for $53.00 per share in cash. If you are a Soleno shareholder, click here to learn more about your legal rights and options. Whitestone REIT (NYSE: WSR)'s sale to Ares Management Corporation for $19.00 per share or unit. If you are a Whitestone shareholder, click here to learn more about your legal rights and options. On behalf of shareholders, Halper Sadeh LLC may seek increased consideration, additional disclosures and information, or other relief and benefits. Halper Sadeh LLC represents investors all over the world who have fallen victim to securities fraud and corporate misconduct. Our attorneys have been instrumental in implementing corporate reforms and recovering millions of dollars on behalf of defrauded investors. Attorney Advertising. Prior results do not guarantee a similar outcome. Contact Information: Halper Sadeh LLC Daniel Sadeh, Esq. Zachary Halper, Esq. One World Trade Center 85th Floor New York, NY 10007 (212) 763-0060 [email protected] [email protected] https://www.halpersadeh.com SOURCE Halper Sadeh LLP |
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Merck Announces Expiration of Hart-Scott-Rodino Act Waiting Period to Acquire Terns Pharmaceuticals, Inc. | FMP Stock News | |
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RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (“HSR”), in connection with Merck's pending acquisition of Terns Pharmaceuticals, Inc. (“Terns”) (Nasdaq: TERN) expired at 11:59 p.m., Eastern Time, on April 23, 2026. As previously announced on April 7, 2026, Merck commenced, through a subsidiary, a cash tender offer to purchase. |
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2026-06-12 11:52
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2026-04-27 08:05
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Terns Pharmaceuticals Announces FDA Breakthrough Therapy Designation Granted to TERN-701 for Certain Patients with Chronic Myeloid Leukemia | FMP Stock News | |
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Designation for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP) without the T315I mutation previously treated with two or more tyrosine kinase inhibitors (TKIs) April 27, 2026 08:05 ET | Source: Terns Pharmaceuticals, Inc.FOSTER CITY, Calif., April 27, 2026 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to TERN-701, a novel, oral allosteric BCR::ABL1 inhibitor, for the treatment of adult patients with Ph+ CML in the chronic phase without the T315I mutation previously treated with two or more TKIs. “There remains an urgent need for CML treatments that offer improved efficacy, safety, and tolerability over current therapies,” said Scott Harris, chief development and operations officer at Terns. “This designation from the FDA supports the significant potential of TERN-701 to be a best-in-disease therapy for CML patients and offer substantial improvement based on the faster, deeper responses compared to prior TKIs and encouraging safety and tolerability profile observed to date.” “This Breakthrough Therapy Designation, along with the recent agreement for Merck to acquire Terns, has the potential to accelerate efforts to advance TERN-701 to a pivotal trial and to patients,” said Amy Burroughs, chief executive officer of Terns. “This is an exciting time for everyone involved in the TERN-701 program. We are grateful to the investigators, patients and community advocates whose dedication and support have made these advancements possible.” Breakthrough Therapy Designation (BTD) is intended to expedite the development and review of potential new medicines designed to treat serious conditions or address significant unmet medical needs. Based on FDA guidelines, the medicine needs to have shown encouraging preliminary clinical evidence that demonstrates potential for substantial improvement over available medicines. TERN-701 BTD is based on data from the ongoing Phase 1/2 CARDINAL clinical trial of TERN-701 in patients with CML previously treated with at least one prior TKI and who experienced treatment failure, suboptimal response or treatment intolerance. TERN-701 has shown promising activity, with encouraging rates of major molecular response and deep molecular response observed at week 24. Importantly, this includes responses in patients with high baseline disease burden who previously received multiple lines of therapy, including many who were treated with an allosteric TKI. The majority of treatment-emergent adverse events were reported as low grade with a low incidence of severe adverse events and discontinuations. About Terns Pharmaceuticals Terns Pharmaceuticals is a clinical-stage oncology company reimagining known biology to deliver high impact medicines. Our lead program, TERN-701, is a highly selective, oral, allosteric BCR::ABL1 inhibitor with a potentially best-in-disease profile that could meaningfully improve upon the efficacy, safety and convenience of existing treatments for chronic myeloid leukemia. For more information, please visit: www.ternspharma.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements about the Company within the meaning of the federal securities laws that involve substantial risks and uncertainties. Forward-looking statements include statements related to or in connection with, expectations, timing and potential results of clinical trials and other development activities, including with respect to the CARDINAL trial; the potential indications to be targeted by the Company with its product candidates; the therapeutic potential of the Company’s product candidates; the potential for the mechanisms of action of the Company’s product candidates to be therapeutic targets for their targeted indications; the potential utility and progress of the Company’s product candidates in their targeted indications, including the clinical utility of the data from and the endpoints used in the Company’s clinical trials; the applicability of expected parameters and benchmarks on which to assess clinical trial results; the Company’s clinical development plans and activities, including potential future dosing regimens and trial designs, milestones and results of any interactions with regulatory authorities on its programs; the Company’s expectations regarding the profile and potential benefit characteristics and therapeutic effects of its product candidates, including with respect to efficacy, tolerability, safety, convenience and pharmacokinetic profile; the potential differentiation of the Company’s product candidates compared to similar, competitive or other products or product candidates; the best in disease potential for TERN-701; the Company’s plans for and ability to continue to execute on its current development strategy, the process, timing or potential to establish a strategic partnership or similar arrangement for future development and/or potential commercialization of any of its product candidates, the potential approval and commercialization of the Company’s product candidates and the Company’s expectations with regard to its cash runway and sufficiency of its cash resources. All statements other than statements of historical facts contained in this press release, including statements regarding the Company’s strategy, future financial condition, future operations, future trial results, future approvals, future commercial launches, projected costs, prospects, plans, objectives of management and expected industry and market trends, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “develop,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company’s plans to vary materially, including the risks associated with the initiation, cost, timing, progress, results and utility of the Company’s current and future research and development activities and preclinical studies and clinical trials. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s reports filed with the Securities and Exchange Commission, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2025. New risk factors emerge from time to time and it is not possible for Company management to predict all risk factors, nor can the Company assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. Contacts for Terns Investors Justin Ng [email protected] Media Jenna Urban CG Life [email protected] |
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2026-06-12 11:52
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2026-04-27 11:02
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Buy, Sell or Hold MRK Stock With Q1 Earnings Around the Corner? | FMP Stock News | |
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Merck MRK is set to report its first-quarter 2026 earnings on April 30, before market open. The Zacks Consensus Estimate for first-quarter top line is pegged at $15.90 billion, while the same for the bottom line stands at a loss of $1.51 per share. |
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2026-06-12 11:52
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2026-05-03 09:35
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Merck: 'Strong Buy' - Terns Acquisition And Ability To Counter Keytruda Patent Loss | FMP Stock News | |
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Merck retains a 'strong buy' rating, driven by proactive oncology pipeline expansion to offset KEYTRUDA patent expiration in 2028. Acquisition of Terns Pharmaceuticals brings TERN-701, a best-in-disease oral BCR-ABL1 TKI for CML, with multibillion-dollar potential and recent FDA Breakthrough Therapy Designation. The company advances the KEYTRUDA family with QLEX SC formulation and combination therapies, targeting new PDUFA approvals in bladder and renal cancers through 2026. |
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2026-06-12 11:52
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2026-05-05 08:45
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Merck Completes Acquisition of Terns Pharmaceuticals, Inc. | FMP Stock News | |
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-Addition of TERN-701, a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor, further diversifies Merck’s oncology pipeline RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the successful completion of the acquisition of Terns Pharmaceuticals, Inc. (“Terns”) (Nasdaq: TERN). “The Terns acquisition reflects Merck’s continued focus on science‑driven, value‑enhancing business development aimed at bringing meaningful innovation to patients,” said Robert M. Davis, chairman and chief executive officer, Merck. “We believe TERN‑701 has the potential to become a differentiated treatment option for certain patients with chronic myeloid leukemia, and we look forward to working with the Terns team to advance its clinical development.” TERN-701 was recently granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in the chronic phase without the T315I mutation previously treated with two or more tyrosine kinase inhibitors (TKIs). The BTD designation for TERN-701 is based on data from the ongoing Phase 1/2 CARDINAL trial (NCT06163430). Transaction details Merck completed the cash tender offer, through a subsidiary, for all the outstanding shares of common stock of Terns at a purchase price of $53.00 per share, without interest and subject to any applicable tax withholding. As of the tender offer expiration at one minute after 11:59 p.m., Eastern Time, on May 4, 2026, 100,091,794 shares of Terns common stock were validly tendered and not validly withdrawn, representing approximately 86.36% of the total number of Terns’ issued and outstanding shares of common stock as of such date and time. All such shares have been accepted for payment in accordance with the terms of the tender offer, and Merck, on behalf of its subsidiary, will promptly pay for such shares. Following the completion of the tender offer, Merck completed the acquisition of Terns through a merger of Merck’s wholly-owned subsidiary with and into Terns, with Terns being the surviving corporation, in which all shares of Terns common stock issued and outstanding at the effective time of the merger were converted into the right to receive cash equal to the $53.00 offer price per share, without interest and subject to any applicable tax withholding. At the completion of the merger, Terns became a wholly-owned subsidiary of Merck and Terns’ common stock will no longer be listed or traded on the Nasdaq Global Select Market. The transaction is expected to be accounted for as an asset acquisition, resulting in a charge to research and development expense of approximately $5.8 billion, or approximately $2.35 per share, included in both second quarter and full year 2026 GAAP and non-GAAP results. Additionally, GAAP and non-GAAP EPS are expected to be negatively impacted by approximately $0.12 per share in 2026, representing costs associated with advancing TERN-701 and costs of financing. About TERN-701 TERN-701 is a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor (TKI) designed to bind to the ABL myristoyl pocket, with a potentially best-in-disease profile that could improve upon existing treatments for certain patients with chronic myeloid leukemia (CML). About chronic myeloid leukemia Chronic myeloid leukemia (CML) is a slow growing type of blood cancer that leads to an overproduction of white blood cells that accumulate in the blood and bone marrow, disrupting the production of healthy blood cells. CML is commonly associated with the Philadelphia chromosome, a translocation between chromosomes 9 and 22 that results in constitutive activation of the BCR::ABL1 fusion protein, which fuels cancer growth. About Merck in hematology Merck is advancing a pipeline of hematology candidates targeting a diverse range of targets across leukemias, lymphomas and myeloproliferative neoplasms. Candidates in Phase 3 development include: bomedemstat (MK-3543), an investigational, orally available lysine-specific demethylase 1 (LSD1) inhibitor; nemtabrutinib (MK-1026), an investigational, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor; and zilovertamab vedotin (MK-2140), an investigational antibody-drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1). Additionally, MK-1045, an investigational CD19xCD3 T-cell engager, is currently being evaluated in a Phase 1b/2 trial. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expects,” “intends,” “believes,” “may,” “plan” or “will.” There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and the company’s other filings with the SEC available at the SEC’s Internet site (www.sec.gov). More News From Merck & Co., Inc. Back to Newsroom |
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2026-06-12 11:52
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2026-05-26 06:18
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Tern shares surge as it ups stakes in AI health services company Talking Medicines | FMP Stock News | |
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Tern PLC (AIM:TERN) shares surged some 30% higher, to 1.18p, after it increased exposure to Talking Medicines - an AI company aiming to help healthcare advertising agencies analyse conversational data for pharmaceutical clients - through around £270,000 of new unsecured convertible loan notes, using a structure that gives the AIM-listed investor roughly twice the principal exposure of its fresh cash and cancelled debt contribution.The investment company, which backs early-stage Internet of Things technology businesses, said the CLNs were issued after it agreed to cancel around £87,000 owed by Talking Medicines and put in a further £48,000 of new funds. The new cash investment was funded from proceeds of Tern’s recent Open Offer. The notes carry 10% annual interest and are convertible on either an exit or a Talking Medicines fundraising of at least £2 million, in each case at a 20% discount to the exit or fundraising price. If neither event takes place, the notes mature on 21 November 2029, in line with Tern’s existing £0.52 million of convertible loan notes in Talking Medicines. Following the issue, Tern’s equity stake in Talking Medicines remains unchanged at around 23.8%, while its total convertible loan note holding rises to around £0.79 million. |
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2026-06-12 11:52
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2026-04-29 08:00
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AI Financial Corporation (Formerly ALT5 Sigma) Begins Trading Under New Nasdaq Ticker Symbol 'AIFC' | FMP Stock News | |
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Ticker Change Reflects the Company's Continued Evolution Across Payments, Tokenization and AI-Driven InfrastructureLAS VEGAS, NV / ACCESS Newswire / April 29, 2026 / AI Financial Corporation (NASDAQ:AIFC)(FRA:5AR1) ("AiFi" or the "Company"), formerly ALT5 Sigma Corporation (NASDAQ:ALTS), a fintech company providing blockchain-powered payment, trading, and settlement infrastructure for digital assets, today announced that its common stock will begin trading under its new corporate name and Nasdaq ticker symbol, AIFC, effective at the open of market trading today, Wednesday, April 29, 2026. The Company's common stock ceased trading under the ticker symbol ALTS following after-market trading on Tuesday, April 28, 2026, and now trades under the new ticker symbol AIFC. The Company will continue to trade on The Nasdaq Stock Market without interruption, and the CUSIP number associated with its common stock will remain unchanged. The Company's Frankfurt ticker symbol, 5AR1, will remain unchanged. No action is required by existing stockholders. The name change reflects the Company's continued evolution toward a broader financial platform that will be designed to support increasingly programmable and automated financial activity. Tony Isaac, President and Chief Executive Officer, stated, "Today marks an important milestone as we begin trading as AI Financial Corporation under our new Nasdaq ticker symbol, AIFC. Our focus has been on building a strong operating foundation across payment processing, trading, and settlement. AiFi represents the next step in that evolution, positioning the Company to evaluate opportunities at the intersection of payments, tokenization, and AI." About AI Financial Corporation (AiFi) AI Financial Corporation (NASDAQ:AIFC) is a fintech company providing global payments, trading, and settlement infrastructure for digital assets, including solutions that support crypto-to-fiat and fiat-to-crypto transactions. Built on infrastructure that has processed more than $8 billion in cumulative transaction volume since inception, AiFi serves institutional and enterprise clients across the evolving digital financial ecosystem. The Company is focused on expanding its platform capabilities to support emerging forms of financial activity, including tokenization, software-driven financial systems, and AI-enabled applications and autonomous transaction infrastructure. Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Forward-looking statements generally relate to future events or the Company's future financial or operating performance and may include statements regarding the Company's strategic direction, the expected benefits of the corporate name and ticker symbol change, and potential future initiatives. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "potential," "continue," or the negative of these terms or other comparable terminology. These statements are based on management's current expectations, assumptions, and beliefs, and are subject to a number of risks, uncertainties, and other factors that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to: the availability of capital to support future development; the Company's ability to develop, acquire, or integrate new technologies; the Company's ability to execute on its strategy under its new corporate identity and ticker symbol; changes in market conditions; regulatory developments affecting the Company's business; and other risks and uncertainties described in the Company's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent filings. Forward-looking statements relating to potential future platform capabilities, including those associated with tokenized assets and on-chain financial infrastructure, are subject to ongoing evaluation. The Company does not currently offer certain of these capabilities within its commercial platform, and there can be no assurance that such capabilities will be successfully developed or implemented. Forward-looking statements speak only as of the date they are made, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Investor Relations Gateway Group, Inc. Phone: +1 (949) 574-3860 Email: [email protected] SOURCE: AI Financial Corporation |
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2026-06-12 11:52
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2026-05-06 07:30
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Altimmune to Report First Quarter 2026 Financial Results and Provide Business Update on May 13, 2026 | FMP Stock News | |
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GAITHERSBURG, Md., May 06, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced that it will report its first quarter 2026 financial results on Wednesday, May 13, 2026. |
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2026-06-12 11:52
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2026-05-13 07:15
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Altimmune to Present Results of Pemvidutide in MASH in an Oral Presentation and Multiple Poster Presentations at EASL Congress 2026 | FMP Stock News | |
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May 13, 2026 07:15 ET | Source: Altimmune, IncAbstract presenting 48-week IMPACT Phase 2b efficacy and safety data selected for inclusion in “Best of EASL 2026” by EASL Oral presentation will highlight further the 48-week IMPACT efficacy and safety data Late-breaker abstract featuring new digital pathology analysis of liver fibrosis regression from IMPACT 24-week data GAITHERSBURG, Md., May 13, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced that analyses of data from its IMPACT Phase 2b clinical trial in metabolic dysfunction-associated steatohepatitis (MASH) will be presented at the European Association for the Study of the Liver (EASL) Congress 2026, taking place May 27-30 in Barcelona, Spain. Data will be featured in both an oral presentation and several poster sessions, including a late-breaking poster presentation. The company also announced that its abstract on 48-week results has been selected by EASL as Best of EASL 2026 in their summary deck for its noteworthy contribution to the scientific program of the EASL congress. The oral presentation will showcase 48-week efficacy and safety results from the IMPACT Phase 2 trial, while additional poster presentations will focus on new 24-week findings, including digital pathology analysis of fibrosis regression, a response analysis to multiple non-invasive tests (NITs) of liver inflammation and fibrosis and data on cardiovascular measures. Oral Presentation Abstract Title: Week 48 Top-Line Results from the Phase 2b, Multicenter, Randomized, Placebo-Controlled IMPACT Trial of Pemvidutide in Metabolic Dysfunction-Associated Steatohepatitis Session: MASLD: Clinical and Therapeutic Aspects I (OS-016) Date/Time: Thursday, May 28, 17:00 CEST Presenter: Dr. Mazen Noureddin, Professor of Medicine, Houston Methodist Hospital; Chief Scientific Officer and Co-Chairman, Summit Clinical Research Poster Presentations Late-Breaking Poster Abstract Title: Pemvidutide Treatment Led to Fibrosis Regression After 24 Weeks in Patients with MASH: Quantitative Digital Pathology Analysis from the Phase 2b IMPACT Trial Session: Late Breaker Posters (LBP-036) Date/Time: Wednesday, May 27, 08:30 CEST Presenter: Dr. Shaheen Tomah, Director, Clinical Development, Altimmune Poster Presentation Abstract Title: Concurrent Responses in Multiple Non-Invasive Tests for Hepatic Inflammation and Fibrosis Following Pemvidutide Treatment: 24-Week Responder Analyses from the Phase 2b IMPACT Trial Session: MASLD: Therapy (TOP-176) Date/Time: Friday, May 29, 08:30-17:00 CEST Presenter: Dr. Scot Roberts, Chief Scientific Officer, Altimmune Poster Presentation Abstract Title: Effect of Pemvidutide on Cardiovascular Risk Factors in Patients with MASH: 48-Week Results from the Phase 2b IMPACT Trial Session: MASLD: Therapy (FRI-201) Date/Time: Friday, May 29, 08:30-17:00 CEST Presenter: Dr. Shaheen Tomah, Director, Clinical Development, Altimmune A copy of the oral presentation and posters will be available in the Events section of the Altimmune website. About the IMPACT Phase 2b Study The randomized, placebo-controlled, double-blind IMPACT Phase 2b trial (NCT05989711) enrolled 212 participants with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis stages F2 or F3, with and without diabetes. Study participants were randomized 1:2:2 to receive weekly subcutaneous pemvidutide doses at either 1.2 mg, 1.8 mg or placebo for 48 weeks. The primary efficacy endpoints, measured at 24 weeks, were MASH resolution without worsening of fibrosis, or fibrosis improvement without worsening of MASH. Secondary endpoints included non-invasive tests of fibrosis and weight loss measured at 24 and 48 weeks. About Pemvidutide Pemvidutide is a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity, in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). The activation of glucagon receptors results in direct effects on the liver, including reductions in liver fat, inflammation and fibrosis, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss. The FDA granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. In December 2025, the Company announced 48-week data from the IMPACT Phase 2b trial in MASH. The Phase 2 RECLAIM trial in AUD and RESTORE trial in ALD were initiated in May 2025 and July 2025, respectively, and are currently ongoing. About Altimmune Altimmune is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company’s lead candidate, pemvidutide, is a unique dual-action therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedIn. Follow @AltimmuneInc on X. Forward-Looking Statements Any statements made in this press release related to the development or commercialization of pemvidutide, an investigational product candidate, and other business, regulatory and financial matters including without limitation, clinical trial study design, status, correspondence, results and data, including related to the completed IMPACT trial, or the ongoing RECLAIM and RESTORE trials, the timing of key milestones for the Company’s clinical programs, future plans or expectations for pemvidutide for the treatment of MASH, AUD and ALD, the potential benefits of Fast Track and Breakthrough Therapy Designations, including potential regulatory timeline and approval benefits, the Company’s financial position, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, financial results, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates; the Company's ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at www.sec.gov. Investor Contact: Luis Sanay, CFA Vice President, Investor Relations [email protected] Media Contact: Real Chemistry [email protected] |
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2026-06-12 11:52
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Altimmune Announces First Quarter 2026 Financial Results and Business Update | FMP Stock News | |
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Initiation of PERFORMA Phase 3 MASH trial planned for second half 2026 $535 million in cash, cash equivalents and short-term investments as of April 30, 2026 Webcast to be held today at 8:30 a.m. ET GAITHERSBURG, Md. |
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2026-06-12 11:52
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2026-05-13 10:08
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Altimmune Q1 Earnings Call Highlights | FMP Stock News | |
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MarketBeat Week in Review – 11/4 - 11/8Altimmune NASDAQ: ALT said it has strengthened its balance sheet and is preparing to begin a global Phase 3 trial of pemvidutide in metabolic dysfunction-associated steatohepatitis, or MASH, in the second half of 2026, as the company reported first-quarter financial results and provided updates across its liver disease pipeline.President and Chief Executive Officer Jerome Durso said the company has made progress since the start of the year in building its team, advancing pemvidutide and securing additional capital. In April, Altimmune completed an oversubscribed public offering that generated $225 million in gross proceeds. Together with existing funds, the company had approximately $535 million in cash as of April 30, which Durso said is expected to fund operations through the Phase 3 MASH 52-week data readout expected in 2029. Get Altimmune alerts: How Altimmune Could Grab a Big Chunk of the GLP-1 Market“We’re entering a new phase for the company with the right team in place and a very strong balance sheet,” Durso said. “We’re now focused on execution and believe we’re well-positioned to successfully execute our strategy.” Phase 3 MASH Trial Set to Begin in Second Half Altimmune’s lead program is pemvidutide, a balanced 1-to-1 glucagon and GLP-1 dual agonist being developed for MASH and other liver conditions. Durso said the company has finalized the protocol for its global Phase 3 MASH trial, called PERFORMA, and submitted it to the U.S. Food and Drug Administration as part of the standard process. He also said Altimmune completed the scientific advice process in Europe and that the final protocol is aligned with feedback from the European Medicines Agency. This Small Cap Wealth Management Stock Could Provide Big ReturnsChief Medical Officer Dr. Christophe Arbet-Engels said startup activities for PERFORMA are progressing as planned, including work with a contract research organization, global vendors, laboratories and clinical supply chains. He said the company expects to begin screening and enrolling patients in the second half of the year. Arbet-Engels said the company has alignment with both the FDA and EMA on the Phase 3 trial design. He described PERFORMA as an event-driven study, with a 52-week biopsy-based interim analysis intended to support accelerated approval. The company expects the 52-week data readout in 2029. The Phase 3 program will evaluate 1.8 mg and 2.4 mg doses of pemvidutide. Arbet-Engels said the 1.8 mg dose is the company’s “anchor dose” based on Phase 2 data, while the 2.4 mg dose is being included because it showed additional weight loss in a prior obesity study and may offer added liver efficacy. He said the study is powered conservatively using the effect size observed with the 1.8 mg dose. Company Highlights Tolerability and Weight Loss Profile Durso and other executives emphasized what they described as pemvidutide’s potentially differentiated profile in MASH, including tolerability, efficacy and “quality weight loss.” Durso said recent market research conducted by the company indicated that prescribing decisions in MASH may be influenced by a favorable tolerability profile that does not sacrifice efficacy, along with quality weight loss. Chief Commercial Officer Linda M. Richardson said pemvidutide’s potential target product profile includes early metabolic benefits, improvements in inflammation and fibrosis, weight loss that may help preserve lean muscle mass, and a simple titration schedule. She said that in the Phase 2 IMPACT trial, both the 1.2 mg and 1.8 mg doses were efficacious and well-tolerated, with fewer adverse event-related discontinuations in the pemvidutide arms than in the placebo group. Richardson contrasted pemvidutide’s planned titration approach with some GLP-1-based therapies, which she said have been associated with gastrointestinal side effects and discontinuations in clinical trials and real-world use. She said the Phase 3 design starts at an active 1.2 mg dose and escalates to either 1.8 mg or 2.4 mg after one or two four-week titration steps. Richardson also said the company plans to evaluate lean muscle mass preservation in the Phase 3 MASH program, noting that MASH patients are often diagnosed in an age range where muscle loss becomes more clinically relevant. Additional Pemvidutide Data Expected in 2026 Arbet-Engels said the 48-week results from the Phase 2 IMPACT trial will be presented orally by Dr. Mazen Noureddin at the EASL conference in Barcelona later this month. He said the abstract was selected as a “best of EASL” abstract. Altimmune also plans to present three posters at the conference covering cardiovascular risk factors, weight loss, noninvasive tests and qFibrosis. During the question-and-answer session, Arbet-Engels said the EASL presentations will include additional qFibrosis evidence related to early anti-fibrotic effects at 24 weeks, as well as analyses related to weight loss, lipids and cardiovascular risk. He said qFibrosis is distinct from the AIM-MASH AI Assist tool that Altimmune plans to incorporate into the Phase 3 biopsy read process. Arbet-Engels said Altimmune expects top-line data next quarter from the Phase 2 RECLAIM trial of pemvidutide in alcohol use disorder, or AUD. The study is evaluating the 2.4 mg dose in 100 subjects with moderate to severe AUD over 24 weeks. The primary endpoint is change from baseline in heavy drinking days, defined as five or more drinks for men and four or more drinks for women in a 24-hour period. Key secondary endpoints include zero heavy drinking days, a two-level reduction in the World Health Organization risk drinking level, changes in alcohol consumption, and changes in body weight and BMI. The company is also measuring phosphatidylethanol, or PEth, as an exploratory blood-based biomarker of alcohol consumption. Durso said that after the AUD data readout, Altimmune will assess the full data set and hold regulatory discussions before deciding whether to advance the indication. If the company sees value in moving forward, he said Altimmune would prefer to explore non-dilutive funding options for the program. Altimmune is also studying pemvidutide in alcohol-associated liver disease, or ALD. The company now expects to complete enrollment in the RESTORE trial in the third quarter of 2026. First-Quarter Financial Results Chief Financial Officer Greg Weaver said Altimmune reported $332 million in cash as of March 31 and $535 million on a pro forma basis as of April 30, after the public offering. He said this cash position is expected to provide operating runway through the Phase 3 MASH 52-week data readout. Research and development expense: $16.2 million in the first quarter of 2026, compared with $15.8 million in the prior-year period. General and administrative expense: $8.1 million, compared with $6.0 million in the first quarter of 2025. Net loss: $22.6 million, or $0.18 per share, compared with a net loss of $19.6 million, or $0.26 per share, in the year-earlier quarter. Weaver said the increase in research and development spending was driven primarily by ongoing AUD and ALD trials, as well as startup costs for the Phase 3 MASH trial, partially offset by lower expenses tied to completion of the Phase 2 IMPACT trial. He said the increase in general and administrative expense was primarily due to severance costs and professional fees. In closing remarks, Durso said Altimmune has made “significant progress” as it evolves into a late-stage company and remains focused on advancing pemvidutide and creating long-term shareholder value. About Altimmune NASDAQ: ALTAltimmune, Inc is a clinical-stage biopharmaceutical company headquartered in Gaithersburg, Maryland, dedicated to the development of vaccines and immunotherapeutics. The company leverages proprietary technology platforms to create intranasal vaccine candidates and novel therapies targeting liver diseases and metabolic disorders. Altimmune's approach emphasizes the stimulation of both systemic and mucosal immune responses to address unmet medical needs in infectious and chronic conditions. Among its lead programs, NasoVAX is an investigational intranasal influenza vaccine designed to provide broad, long-lasting protection through a single, non-invasive dose. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. Should You Invest $1,000 in Altimmune Right Now?Before you consider Altimmune, you'll want to hear this. MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Altimmune wasn't on the list. While Altimmune currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys. View The Five Stocks Here Discover the 10 Best High-Yield Dividend Stocks for 2026 and secure reliable income in uncertain markets. Download the report now to identify top dividend payers and avoid common yield traps. Get This Free Report |
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Altimmune, Inc. (ALT) Q1 2026 Earnings Call Transcript | FMP Stock News | |
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Altimmune, Inc. (ALT) Q1 2026 Earnings Call Transcript |
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Altimmune's Q1 Loss Narrower Than Expected, Revenues Nil | FMP Stock News | |
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Key Takeaways Altimmune reported a narrower Q1 loss as pemvidutide studies advanced across multiple indications.ALT plans a phase III MASH study in H2 2026, with 52-week data expected in 2029.ALT expects top-line AUD study data in Q3 2026 as ALD enrollment progresses toward completion. Altimmune (ALT - Free Report) incurred a first-quarter 2026 loss of 18 cents per share, narrower than the Zacks Consensus Estimate of a loss of 25 cents. The company had recorded a loss of 26 cents per share in the year-ago quarter.The company did not generate any revenues in the first quarter, as it does not have a marketed drug in its portfolio. ALT's Q1 Results in DetailResearch and development (R&D) expenses totaled $16.2 million in the reported quarter, up 2.3% year over year, primarily due to ongoing clinical studies and startup costs associated with the late-stage metabolic dysfunction-associated steatohepatitis (MASH) study. R&D spending included $9.5 million in direct pemvidutide development costs. General and administrative expenses were $8.1 million, up 34.3% year over year, primarily driven by an increase in severance costs and professional fees. As of March 31, 2026, Altimmune had cash, cash equivalents and short-term investments of $332 million compared with $274 million as of Dec. 31, 2025. The company raised $75 million in a registered direct and $8 million via ATM in January-February 2026 and secured $225 million in gross proceeds from an oversubscribed public offering completed in April 2026, bringing pro forma cash to roughly $535 million as of April 30, 2026. Management expects its cash runway to support operations into 2029. Year to date, shares of ALT have declined 16.4% compared with the industry’s 5.4% decline. Image Source: Zacks Investment Research ALT's Key Pipeline UpdatesPemvidutide, Altimmune’s lead candidate, is an investigational dual glucagon/GLP-1 receptor agonist, being developed for MASH, alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). Altimmune had announced 48-week data from the phase IIb IMPACT study in MASH in December 2025. The data showed that pemvidutide delivered significant improvements across key measures in patients with MASH. The company plans to initiate a global phase III registrational PERFORMA study to evaluate the safety and efficacy of pemvidutide in MASH patients with moderate-to-severe liver fibrosis in the second half of 2026, with 52-week data expected in 2029. Top-line data from the mid-stage RECLAIM study evaluating pemvidutide for the treatment of patients with AUD is expected in the third quarter of 2026. Enrollment was completed ahead of schedule in November 2025. Altimmune is also developing the candidate in the phase II RESTORE study in patients with ALD. Patient enrollment is expected to be completed by the third quarter of 2026. ALT's Zacks Rank & Other Stocks to ConsiderAltimmune currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the biotech sector are Amarin Corporation (AMRN - Free Report) , Indivior Pharmaceuticals (INDV - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Amarin’s 2026 loss per share have narrowed from $7.01 to $6.36. Over the same period, loss per share estimates for 2027 have narrowed from $5.50 to $4.64. AMRN shares have risen 7.6% year to date. Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 50.02%. Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.03 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.46. INDV shares have risen 6.9% year to date. Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $1.94 from $1.50. Over the same period, EPS estimates for 2027 have risen to $3.80 from $2.91. LQDA shares have gained 67% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%. |
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Here's Why You Should Add Altimmune Stock to Your Portfolio Now | FMP Stock News | |
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Key Takeaways Altimmune plans to launch a global phase III MASH study for pemvidutide in 2H 2026.ALT reported phase IIb data showing MASH resolution and fibrosis improvement through 48 weeks.Altimmune expects top-line AUD study data in Q3 2026 and is advancing a phase II ALD study. Altimmune (ALT - Free Report) , a late clinical-stage biotech, is focused on developing therapies for liver diseases. Its lead pipeline candidate, pemvidutide, is a balanced 1:1 glucagon/GLP-1 dual receptor agonist and has a differentiated mechanism of action with a “pipeline in a product” potential for the treatment of liver diseases. Altimmune is positioning itself as a differentiated player with the potential to compete in large commercial indications such as metabolic dysfunction-associated steatohepatitis ("MASH"), alcohol use disorder ("AUD") and alcohol-associated liver disease ("ALD").Year to date, shares of Altimmune have lost 18.9% compared with the industry’s 6.5% decline. Image Source: Zacks Investment Research Strong Momentum in the Multi-Billion-Dollar MASH MarketAn important catalyst supporting investor enthusiasm is Altimmune’s expanding opportunity in the MASH market. The disease represents a multi-billion-dollar commercial opportunity with limited approved treatment options. The recent data from the phase IIb IMPACT study evaluating pemvidutide in MASH patients demonstrated statistically significant MASH resolution without worsening of fibrosis at 24 weeks, sustained through 48 weeks. It also showed clear signs of reducing liver scarring by 48 weeks. Key markers of liver damage and inflammation continued to improve over time, showing steady progress with the added benefit of weight loss. The candidate’s relatively simple dosing profile may also support better patient adherence compared with more complex injectable regimens. Altimmune recently announced alignment with the FDA on key parameters for a late-stage MASH program and plans to initiate a global phase III registrational PERFORMA study in the second half of 2026. The study will evaluate pemvidutide in MASH patients with moderate-to-severe fibrosis, with 52-week data expected in 2029. Pemvidutide’s Expansion Beyond MASHBeyond MASH, Altimmune is also evaluating pemvidutide in separate mid-stage studies for alcohol-related diseases like AUD and ALD. Top-line data from the mid-stage RECLAIM study evaluating pemvidutide for the treatment of patients with AUD is expected in the third quarter of 2026. Enrollment was completed ahead of schedule in November 2025. Altimmune is also developing the candidate in the phase II RESTORE study in patients with ALD. Patient enrollment is expected to be completed by the third quarter of 2026. The candidate holds Fast Track designations for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. ALT's Zacks Rank & EstimatesAltimmune currently carries a Zacks Rank #2 (Buy). Over the past 30 days, estimates for ALT’s 2026 and 2027 loss per share have narrowed from $1.00 to 69 cents and from $1.00 to 73 cents, respectively. Other Stocks to ConsiderSome other top-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) , Indivior Pharmaceuticals (INDV - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Immunocore’s 2026 loss per share have narrowed from 97 cents to 16 cents. Over the same period, estimates for 2027 have improved from a loss of 39 cents to earnings of 11 cents per share. IMCR's shares have lost 13.5% year to date. Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%. Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.10 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.47. INDV's shares have risen 4.4% year to date. Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA's shares have gained 79.6% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%. |
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FDA Grants Accelerated Approval to Gilead's Hepcludex® (bulevirtide-gmod), the First and Only Approved Treatment for Chronic Hepatitis Delta Virus (HDV) | FMP Stock News | |
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Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepcludex® (bulevirtide-gmod) 8.5 mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the United States.The FDA granted accelerated approval to Hepcludex based on reductions in HDV RNA and normalization of alanine aminotransferase (ALT), supported primarily by data from the pivotal, controlled Phase 3 MYR301 study. At Week 48, the study demonstrated a statistically significant improvement versus the control (delayed treatment) group in a combined virologic and biochemical response. Improvement in disease-related clinical outcomes has not been established. Continued approval for the approved indication may be contingent on verification and description of clinical benefit in a confirmatory trial. Chronic HDV is considered the most severe form of viral hepatitis and is associated with a markedly higher risk of rapid disease progression, liver failure, and mortality compared with HBV alone. In the United States, studies in general populations have estimated that HDV affects between 2% and 4% of individuals who have chronic hepatitis B virus (HBV), representing ~40,000-80,000 people. “Hepatitis delta virus is associated with rapid progression of liver disease and a high risk of serious or even life-threatening liver-related complications,” said Dr. Ira Jacobson, MD, Department of Medicine at NYU Grossman School of Medicine. “For patients, an HDV diagnosis means managing two distinct viral liver diseases—hepatitis B and hepatitis D—each contributing to disease progression, monitoring demands, and treatment complexities. The approval of Hepcludex for chronic HDV represents a critical advancement, introducing a long-awaited option that begins to address a significant unmet medical need and has the potential to meaningfully alter the course of this devastating disease for people living with HDV in the United States.” MYR301 (NCT03852719) evaluated the efficacy and safety of Hepcludex in adults with chronic HDV, with treatment administered for up to 144 weeks followed by 96 weeks of off-treatment follow-up. Hepcludex met its primary endpoint at Week 48, with continued treatment, demonstrated sustained efficacy and was generally well tolerated through up to 144 weeks of on-treatment exposure. “The approval of Hepcludex represents a historic milestone for people living with HDV in the United States, marking the first FDA-approved treatment for HDV,” said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. “This reflects years of close engagement with the FDA and the application of rigorous science to address a serious disease with long-standing unmet need. With Hepcludex, we now have the opportunity to deliver a meaningful clinical advancement that has the potential to change the trajectory of HDV for patients in the U.S.” U.S. Access and Hepcludex Approval Across Markets The Gilead Support Path® Program offers information and resources to help patients diagnosed with chronic HBV, HDV and hepatitis C virus (HCV) and primary biliary cholangitis (PBC), as well as healthcare professionals, understand coverage and financial options for prescribed Gilead treatments. Bulevirtide 2 mg is also approved for use in the European Economic Area (EEA) and other countries globally to treat people living with chronic HDV. Please see below for U.S. Indication and Important Safety Information for Hepcludex. U.S. Indication for Hepcludex Hepcludex (bulevirtide-gmod) 8.5 mg for injection is indicated for the treatment of chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). U.S. Important Safety Information for Hepcludex IMPORTANT SAFETY INFORMATION BOXED WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS D and B Severe acute exacerbations of hepatitis D and hepatitis B may occur after HEPCLUDEX is discontinued, especially in patients with cirrhosis, who may be at increased risk of more severe flares or progression to hepatic decompensation. Monitor hepatic function closely with both clinical and laboratory follow-up, including hepatitis B virus (HBV) DNA and hepatitis delta virus (HDV) RNA viral load, for at least six months in patients who discontinue HEPCLUDEX. Resumption of antiviral therapy may be warranted. Warnings and Precautions Hypersensitivity reactions including anaphylaxis: Hypersensitivity reactions, including anaphylaxis, have been reported with HEPCLUDEX. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue HEPCLUDEX and initiate appropriate treatment. Adverse Reactions Most common adverse reactions (incidence ≥10%; all grades) in HEPCLUDEX clinical trials were injection site reactions, headache, abdominal pain, fatigue and pruritus. Dosage and Administration Dosage in adults: 8.5 mg once daily administered by subcutaneous injection HEPCLUDEX should be continued as long as it is associated with a response to treatment. The optimal treatment duration is unknown. In all patients, manage the underlying HBV infection as clinically appropriate. Pregnancy and Lactation Pregnancy: There are insufficient data from human pregnancies exposed to HEPCLUDEX to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Lactation: There are no data on the presence of HEPCLUDEX in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HEPCLUDEX and any potential adverse effects on the breastfed child from HEPCLUDEX or from the underlying maternal condition. About Hepcludex (bulevirtide) Hepcludex (bulevirtide) is a first-in-class entry inhibitor for the treatment of adults living with chronic hepatitis delta virus (HDV) infection. Chronic HDV infection is a serious liver disease that occurs only as a co-infection in individuals with chronic HBV and is associated with rapid disease progression, liver failure, and increased mortality. Hepcludex is supplied as a vial for once-daily subcutaneous injection. Each vial contains an 8.5 mg dose when prepared according to the Instructions for Use within FDA-approved labeling. Hepcludex works by blocking the entry of both HDV and HBV into liver cells, addressing a key step in the viral lifecycle. The FDA’s accelerated approval of Hepcludex is supported by data from the Phase 3 MYR301 study demonstrating that Hepcludex was an effective and generally well-tolerated treatment option, with durable efficacy observed through long-term treatment of up to 144 weeks. Hepcludex is supplied as a once-daily injectable therapy and represents the first and only treatment option for people living with HDV that received FDA accelerated approval in the United States, addressing a long-standing unmet medical need for this historically underserved patient community. As part of the FDA accelerated approval, Gilead has committed to a confirmatory long-term outcomes study, which has already been initiated in people living with chronic HDV. Continued approval may be contingent upon verification of clinical benefit. About HDV Chronic HDV is the most severe form of viral hepatitis and can have mortality rates as high as 50% within five years in cirrhotic patients. HDV occurs only as a co-infection in individuals who have HBV. It is estimated that at least 12 million people worldwide are currently co-infected with HDV and HBV. HDV co-infection is associated with a faster progression to liver fibrosis, cirrhosis and hepatic decompensation and an increased risk of liver cancer and death. In the U.S., it is estimated that there are ~40,000-80,000 people living with HDV. About Gilead Sciences in Liver Disease For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. We have helped to transform hepatitis C from a chronic condition into one that can be cured for millions of people. For people living with hepatitis B or D, our focus on advancing our medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, we’re working to deliver advanced treatments for people living with PBC. But our commitment doesn’t stop there. Through our ground-breaking science and collaborative partnerships, we strive to create healthier futures for everyone living with liver disease. We are committed to a future without liver disease. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving bulevirtide; uncertainties relating to regulatory applications and related filing and approval timelines, including additional pending and potential applications for Hepcludex, and the risk that any such approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the risk that physicians may not see the benefits of prescribing Hepcludex for the treatment of HDV; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Hepcludex, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. U.S. full Prescribing Information for Hepcludex is available at www.gilead.com. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on businesswire.com: https://www.businesswire.com/news/home/20260522569258/en/ |
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New IMPACT Phase 2b Data Highlight Concurrent Improvements Across Multiple Non-Invasive Markers and qFibrosis-Measured Fibrosis Regression with Pemvidutide in MASH at EASL 2026 | FMP Stock News | |
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May 27, 2026 08:00 ET | Source: Altimmune, IncConcurrent improvement across key non-invasive tests underscores convergence of pemvidutide effects on MASH disease activity and fibrosis AI-based digital pathology analyses further demonstrate antifibrotic effects of pemvidutide at 24 weeks GAITHERSBURG, Md., May 27, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced that new analyses of data from the IMPACT Phase 2b trial demonstrated that treatment with pemvidutide, an investigational, balanced 1:1 glucagon/GLP-1 dual receptor agonist, is associated with concurrent improvements across multiple non-invasive tests (NITs) of metabolic dysfunction-associated steatohepatitis (MASH) activity and fibrosis. These new data reinforce a consistent and clinically meaningful treatment effect observed at just 24 weeks. These findings are based on analyses of overlapping markers of liver fat, inflammation and fibrosis. The analyses are further supported by separate AI-based digital pathology data showing significant improvements in fibrosis stage by HistoIndex qFibrosis® at 24 weeks, providing potent evidence of the antifibrotic potential of pemvidutide. The data are being presented today and Friday in poster sessions, including a late-breaking poster presentation, at the European Association for the Study of the Liver (EASL) Congress 2026 in Barcelona, Spain. “The ability of pemvidutide to demonstrate concurrent improvements across multiple non-invasive markers – and to see those findings supported by histologic measures of fibrosis – provides a more comprehensive and clinically meaningful view of its potential beneficial effect in patients with MASH,” said Naim Alkhouri, MD, Chief Medical Officer, Summit Clinical Research. “These results point to the potential ability of pemvidutide to address multiple dimensions of disease biology, including fibrosis, and support its potential to target key drivers of MASH.” Highlights of the data presented at EASL 2026 include: Pemvidutide treatment resulted in significant increases in the percentage of patients achieving concurrent improvements across key NITs compared with placebo at 24 weeks – including in liver fat content (LFC), alanine aminotransferase (ALT), liver stiffness measurement (LSM) and enhanced liver fibrosis (ELF).37.8% of patients taking pemvidutide 1.2 mg and 22.7% of patients taking pemvidutide 1.8 mg achieved concurrent >0.5 ELF reduction plus >30% LSM reduction compared with 8.3% of patients taking placebo (p=0.0002 and p=0.02, respectively). These overlapping NIT responses provide a more stringent and clinically meaningful assessment of treatment effect and also evidence of improvement across multiple dimensions of disease biology. The findings are further supported by AI-based digital pathology analyses using qFibrosis, which utilizes advanced Second Harmonic Generation (SHG)/Two-Photon Excitation Fluorescence (TPEF) imaging to quantify fibrosis across the entire biopsy sample, enabling detection of continuous and intra-stage changes in fibrosis. Those results showed: Pemvidutide treatment led to significant reductions in continuous fibrosis values versus placebo.68.6% of patients taking pemvidutide 1.2 mg and 54.5% of patients taking pemvidutide 1.8 mg achieved ≥1 stage qFibrosis regression compared with 29.6% of patients taking placebo (p<0.001 and p=0.002, respectively) after 24 weeks of treatment. “The consistency of these findings across non-invasive markers and advanced imaging approaches reflects the potential early impact of pemvidutide in addressing MASH,” said Christophe Arbet-Engels, M.D., Ph.D., Chief Medical Officer of Altimmune. “These multiple consistent analyses strengthen our confidence in pemvidutide and its potential to address significant unmet needs among patients living with MASH. In addition, 48-week data demonstrating a clear dose effect at the 1.8 mg dose further reinforces our confidence in the robustness and durability of the clinical response. Based on these promising Phase 2b clinical data, we are excited to begin patient enrollment in our PERFORMA Phase 3 trial of pemvidutide in patients with MASH in the second half of this year.” About the IMPACT Phase 2b Study The randomized, placebo-controlled, double-blind IMPACT Phase 2b trial (NCT05989711) enrolled 212 participants with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis stages F2 or F3, with and without diabetes. Study participants were randomized 1:2:2 to receive weekly subcutaneous pemvidutide doses at either 1.2 mg, 1.8 mg or placebo for 48 weeks. The primary efficacy endpoints, measured at 24 weeks, were MASH resolution without worsening of fibrosis, or fibrosis improvement without worsening of MASH. Secondary endpoints included non-invasive tests of fibrosis and weight loss measured at 24 and 48 weeks. About Pemvidutide Pemvidutide is a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity, in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). The activation of glucagon receptors results in direct effects on the liver, including reductions in liver fat, inflammation and fibrosis, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss. The FDA granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. In December 2025, the Company announced 48-week data from the IMPACT Phase 2b trial in MASH. The RECLAIM Phase 2 trial in AUD completed enrollment in November 2025 and topline data are expected in third quarter 2026. The RESTORE trial in ALD was initiated in July 2025, and enrollment completion is expected in the third quarter 2026. The Company plans to initiate the PERFORMA Phase 3 trial, a multinational, randomized, double-blind, placebo-controlled, parallel-group study of pemvidutide in patients with MASH in the second half of 2026. About Altimmune Altimmune is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company’s lead candidate, pemvidutide, is a unique dual-action investigational therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedIn Follow @AltimmuneInc on X Forward-Looking Statements Any statements made in this press release related to the development or commercialization of pemvidutide, an investigational product candidate, and other business, regulatory and financial matters including without limitation, clinical trial study design, status, correspondence, results and data, including the ongoing RECLAIM and RESTORE trials and planned PERFORMA Phase 3 trial, the timing of key milestones for the Company’s clinical programs, including the anticipated launch of the PERFORMA Phase 3 trial in MASH, future plans or expectations for pemvidutide for the treatment of MASH, AUD and ALD, the potential benefits of Fast Track and Breakthrough Therapy Designations, including potential regulatory timeline and approval benefits, the Company’s financial position, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, financial results, and the impact of the changes to our leadership and governance structure, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates; the Company's ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at www.sec.gov. Investor Contact: Luis Sanay, CFA Vice President, Investor Relations [email protected] Media Contact: Real Chemistry [email protected] |
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Altimmune to Participate in Upcoming Investor Conferences | FMP Stock News | |
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May 27, 2026 08:30 ET | Source: Altimmune, IncGAITHERSBURG, Md., May 27, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced that management will participate in the following upcoming investor conferences: 2026 Jefferies Global Healthcare Conference Thursday, June 4, 2026 Fireside chat at 12:50 p.m. ET New York, NY Goldman Sachs 47th Annual Global Healthcare Conference Wednesday, June 10, 2026 Fireside chat at 8:00 a.m. ET Miami Beach, FL A webcast of the fireside chats will be available via the Events section of the Altimmune website. About Altimmune Altimmune is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company’s lead investigational candidate, pemvidutide, is a unique dual-action therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedIn Follow @AltimmuneInc on X Investor Contact: Luis Sanay, CFA Vice President, Investor Relations [email protected] Media Contact: Real Chemistry [email protected] |
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2026-05-28 11:00
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Pemvidutide Demonstrates Significant Metabolic Improvements in Patients with MASH in New 48‑Week IMPACT Phase 2b Data Presented at EASL 2026 | FMP Stock News | |
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May 28, 2026 11:00 ET | Source: Altimmune, Inc“Best of EASL” oral presentation highlights meaningful reductions in triglycerides, cholesterol, and blood pressure, along with improvements in key metabolic risk factors PERFORMA Phase 3 trial to further evaluate the broad metabolic and liver-related effects of pemvidutide GAITHERSBURG, Md., May 28, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced that new 48-week data from the IMPACT Phase 2b trial show that pemvidutide, an investigational balanced glucagon/GLP-1 dual receptor agonist, significantly reduced elevated lipids while improving multiple cardiometabolic risk factors in patients with metabolic dysfunction-associated steatohepatitis (MASH). The findings demonstrated reductions in triglycerides and total cholesterol, along with improvements in weight, waist circumference and blood pressure, highlighting the broad impact of pemvidutide on key drivers of MASH. The data were presented for the first time at the European Association for the Study of the Liver (EASL) Congress 2026 in Barcelona, Spain. “MASH therapies that can address both liver disease and its underlying metabolic drivers are urgently needed to improve outcomes for patients,” said Mazen Noureddin, M.D., IMPACT trial principal investigator, Professor of Medicine at Houston Methodist Hospital, and Chief Scientific Officer and Co-Chairman of Summit Clinical Research. “These 48-week IMPACT trial findings are particularly compelling because they demonstrate meaningful reductions in liver fat and fibrosis biomarkers, and in lipids elevated at baseline, alongside improvements in weight and other cardiometabolic risk factors. In patients with MASH, where cardiovascular disease remains a leading cause of mortality, seeing this type of broad metabolic impact is highly relevant to overall patient outcomes." Highlights of the 48-week data presented at EASL 2026 include: Pemvidutide 1.8 mg treatment resulted in significant reductions in serum lipid levels among patients with elevated baseline values versus placebo, including: Triglycerides reductions of -23.7%Total cholesterol reductions of -15.4% In addition to lipids, pemvidutide 1.8 mg treatment resulted in significant improvements in other metabolic risk factors versus placebo: Weight loss of 7.5%, continuing throughout treatment with no plateauingReductions in body mass index of -3.0 kg/m2Reductions in waist circumference (a measure of visceral adiposity that is associated with increased cardiovascular risk) of -5.3 cmImprovements in systolic blood pressure of -4.0 mmHg and diastolic blood pressure of -2.2 mmHg Results also showed that the safety profile of pemvidutide was maintained at 48 weeks, and the tolerability profile was generally favorable without dose titration. Approximately 1% of total patients receiving pemvidutide discontinued treatment due to adverse events (AEs). The majority of AEs were mild to moderate, and no imbalances in cardiac AEs were observed with pemvidutide versus placebo. Most gastrointestinal AEs were mild to moderate in severity and predominantly occurred within the first 8 weeks. Previously reported IMPACT Phase 2b trial results showed the proportion of patients achieving both a ≥0.5 reduction in Enhanced Liver Fibrosis (ELF) and a ≥30% reduction in Liver Stiffness Measurement (LSM) at week 48 was 3.2% with placebo, compared with 27.8% for pemvidutide 1.2 mg (p<0.001) and 32.4% for pemvidutide 1.8 mg (p<0.0001). “These new 48-week results highlight the breadth of the impact of pemvidutide across some of the most critical cardiometabolic risk factors, including lipids, weight and blood pressure,” said Christophe Arbet-Engels, M.D., Ph.D., Chief Medical Officer of Altimmune. “Across multiple analyses, we are seeing consistent data that reinforce our confidence in the unique mechanism of pemvidutide – a balanced 1:1 ratio of glucagon and GLP-1 – and its potential to address significant unmet needs in this patient population. Given the promising findings from the IMPACT Phase 2b trial, we are eager to initiate our PERFORMA Phase 3 trial later this year to further assess the efficacy and safety of pemvidutide in patients with MASH.” About the IMPACT Phase 2b Study The randomized, placebo-controlled, double-blind IMPACT Phase 2b trial (NCT05989711) enrolled 212 participants with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis stages F2 or F3, with and without diabetes. Study participants were randomized 1:2:2 to receive weekly subcutaneous pemvidutide doses at either 1.2 mg, 1.8 mg or placebo for 48 weeks. The primary efficacy endpoints, measured at 24 weeks, were MASH resolution without worsening of fibrosis, or fibrosis improvement without worsening of MASH. Secondary endpoints included non-invasive tests of fibrosis and weight loss measured at 24 and 48 weeks. About Pemvidutide Pemvidutide is a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity, in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). The activation of glucagon receptors results in direct effects on the liver, including reductions in liver fat, inflammation and fibrosis, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss. The FDA granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. In December 2025, the Company announced 48-week data from the IMPACT Phase 2b trial in MASH. The RECLAIM Phase 2 trial in AUD completed enrollment in November 2025 and topline data are expected in third quarter 2026. The RESTORE trial in ALD was initiated in July 2025, and enrollment completion is expected in the third quarter 2026. The Company plans to initiate the PERFORMA Phase 3 trial, a multinational, randomized, double-blind, placebo-controlled, parallel-group study of pemvidutide in patients with MASH in the second half of 2026. About Altimmune Altimmune is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company’s lead candidate, pemvidutide, is a unique dual-action investigational therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedIn Follow @AltimmuneInc on X Forward-Looking Statements Any statements made in this press release related to the development or commercialization of pemvidutide, an investigational product candidate, and other business, regulatory and financial matters including without limitation, clinical trial study design, status, correspondence, results and data, including the completed IMPACT and planned PERFORMA Phase 3 trials, the timing of key milestones for the Company’s clinical programs, including the anticipated launch of the PERFORMA Phase 3 trial in MASH, future plans or expectations for pemvidutide for the treatment of MASH, AUD and ALD, the potential benefits of Fast Track and Breakthrough Therapy Designations, including potential regulatory timeline and approval benefits, the Company’s financial position, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates; the Company's ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at www.sec.gov. Investor Contact: Luis Sanay, CFA Vice President, Investor Relations [email protected] Media Contact: Real Chemistry [email protected] |
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2026-06-12 11:52
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2026-05-30 12:00
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Mirum Pharmaceuticals Announces New Data from Rare Liver Disease Programs Presented at the EASL International Liver Congress 2026 | FMP Stock News | |
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Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, today announced new data from its rare liver disease programs. Late-breaking results from the Phase 2b VISTAS study of volixibat in PSC and Phase 2b AZURE-1 study of brelovitug in HDV, alongside data featuring its established therapy, LIVMARLI® (maralixibat), in PFIC, were presented at the European Association for the Study of the Liver (EASL) International Liver Congress 2026.“The results from the VISTAS and Phase 2b AZURE-1 studies represent meaningful progress toward bringing potential new therapies to patients living with PSC and HDV, two serious rare liver diseases with limited treatment options,” said Chris Peetz, Chief Executive Officer at Mirum. “The presented VISTAS results position us well for our planned NDA submission for volixibat later this year, and we are encouraged by the growing body of evidence supporting the long-term use of LIVMARLI in PFIC.” VISTAS Study Results: Treatment with Volixibat in Patients with PSC Demonstrates Rapid, Sustained, and Clinically Meaningful Reductions in Pruritus Treatment with volixibat resulted in the following changes from baseline in patients with moderate-to-severe pruritus at baseline: A 2.72-point reduction and a 1.64-point (p<0.0001) placebo-adjusted reduction in the primary endpoint of cholestatic pruritus, as measured by the Adult Itch Reported Outcome (ItchRO) scale, 56% of patients achieving a ≥2 point reduction in pruritus compared with only 26% of patients on placebo (p=0.0019) and 37% of patients achieving a ≥3 point reduction in pruritus compared with only 11% of patients on placebo (p=0.0011), A mean reduction in serum bile acid (sBA) levels of 33.7 µmol/L compared with a 2.1 µmol/L increase with placebo, for a placebo-adjusted difference of −35.8 µmol/L (p=0.0324), and Trends toward improvement in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep and fatigue scores (sleep: placebo-adjusted difference of −5.69; p=0.0011; fatigue: placebo-adjusted difference of −2.33; p=0.1322). Volixibat’s safety profile was generally consistent with the known effects of IBAT inhibition. Gastrointestinal adverse events and elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and bilirubin were observed more frequently in volixibat-treated patients than placebo-treated patients. “PSC remains a difficult disease to manage, particularly for patients experiencing pruritus, which can significantly impact quality of life,” said Cynthia Levy, M.D., FAASLD, AGAF, Professor of Clinical Medicine at the University of Miami Miller School of Medicine. “The magnitude and consistency of the pruritus improvements observed in VISTAS are encouraging and support the potential of volixibat as a treatment option for pruritus in patients with PSC.” Mirum has a pre-New Drug Application (NDA) meeting for volixibat in PSC scheduled with the U.S. FDA in summer 2026, with a planned NDA submission in the second half of 2026. Phase 2b AZURE-1 Study Results: Treatment with Brelovitug Demonstrates Efficacy and Safety in Patients with HDV, Including Those with Advanced Disease Baseline characteristics reflected a population with advanced disease, including cirrhosis in 53% of patients, elevated ALT levels (mean [SD], 124 [95] U/L), with 21% of patients having ALT ≥5 times the upper limit of normal (ULN), elevated liver stiffness (mean [SD], 16.6 [10.5] kPa), including 15% with liver stiffness ≥25 kPa. At Week 24, treatment with brelovitug resulted in virologic response (≥2 log10 reduction in HDV RNA from baseline or undetectable HDV RNA [ The primary composite endpoint of virologic response and ALT normalization at Week 24 was achieved in 45% and 35% of patients in the 300 mg QW and 900 mg Q4W arms, respectively, versus 0% in the delayed treatment arm. Reductions in liver stiffness as measured by transient elastography were observed in both brelovitug treatment arms at Week 24, with reductions from baseline of 3.6 kPa in the 300 mg QW arm and 2 kPa in the 900 mg Q4W arm, compared to an increase of 1.1 kPa in the delayed treatment arm. Treatment with brelovitug was well tolerated across dose groups, with injection-site reaction (all reported as mild [Grade 1]) being the most common treatment-related adverse event. Low rates of flu-like symptoms were observed. These results build upon prior data to support the potential of brelovitug as a well-tolerated single-agent therapy to treat HDV, including in patients with advanced disease. Topline data from the Phase 3 AZURE-1 and AZURE-4 studies are expected in the second half of 2026, with potential BLA submission and commercial launch in the U.S. in 2027. Treatment with LIVMARLI® (maralixibat) Demonstrates Improved Event-Free Survival (EFS) in Patients with PFIC Compared with a Real-World PFIC Cohort from the NAPPED Database This analysis compared time to first clinical event between PFIC patients aged ≥1 year with non-truncating BSEP deficiency and FIC1 variants treated with LIVMARLI (maralixibat) for up to 4.8 years (n=41) and an external control cohort from the NAtural Course and Prognosis of PFIC and Effect of Biliary Diversion (NAPPED) database (n=256). Events were defined as: surgical biliary diversion (SBD), liver transplantation, or death. The LIVMARLI (maralixibat)-treated cohort showed significant improvement in overall EFS (HR=0.29; 95% CI 0.16-0.54; p=0.0001) as well as in EFS for SBD (HR=0.05 (95% CI 0.01-0.39), p=0.0036) and for liver transplantation or death (HR=0.44 (95% CI 0.22-0.88), p=0.02), respectively. The results of this analysis add to the body of evidence supporting the long-term use of LIVMARLI (maralixibat) in patients with PFIC. About LIVMARLI® (maralixibat) oral solution and tablets LIVMARLI® (maralixibat) is an orally administered, ileal bile acid transporter (IBAT) inhibitor approved by the U.S. Food and Drug Administration for two pediatric cholestatic liver diseases. It is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) in the U.S. three months of age and older and in Europe for patients two months of age and older. It is also approved in the U.S. for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) 12 months of age and older and in Europe for the treatment of PFIC in patients three months of age and older. For more information for U.S. residents, please visit LIVMARLI.com. LIVMARLI has received orphan designation for ALGS and PFIC. LIVMARLI is currently being evaluated in the Phase 3 EXPAND study in additional settings of cholestatic pruritus. To learn more about ongoing clinical trials with LIVMARLI, please visit Mirum’s clinical trials section on the company’s website. IMPORTANT SAFETY INFORMATION Limitation of Use: LIVMARLI is not for use in PFIC type 2 patients who have a severe defect in the bile salt export pump (BSEP) protein. LIVMARLI can cause side effects, including Liver injury. Changes in certain liver tests are common in patients with ALGS and PFIC but can worsen during treatment. These changes may be a sign of liver injury. In PFIC, this can be serious or may lead to liver transplant or death. Your healthcare provider should do blood tests and physical exams before starting and during treatment to check your liver function. Tell your healthcare provider right away if you get any signs or symptoms of liver problems, including nausea or vomiting, skin or the white part of the eye turns yellow, dark or brown urine, pain on the right side of the stomach (abdomen), bloating in your stomach area, loss of appetite or bleeding or bruising more easily than normal. Stomach and intestinal (gastrointestinal) problems. LIVMARLI can cause stomach and intestinal problems, including diarrhea and stomach pain. Your healthcare provider may advise you to monitor for new or worsening stomach problems including stomach pain, diarrhea, blood in your stool or vomiting. Tell your healthcare provider right away if you have any of these symptoms more often or more severely than normal for you. A condition called Fat Soluble Vitamin (FSV) Deficiency caused by low levels of certain vitamins (vitamin A, D, E, and K) stored in body fat is common in patients with Alagille syndrome and PFIC but may worsen during treatment. Your healthcare provider should do blood tests before starting and during treatment and may monitor for bone fractures and bleeding which have been reported as common side effects. [url="]US Prescribing Information [/url] [url="]EU SmPC [/url] Canadian Product Monograph About Volixibat Volixibat is an investigational oral, minimally absorbed agent designed to selectively inhibit the ileal bile acid transporter (IBAT). Volixibat may offer a novel approach in the treatment of adult cholestatic diseases by blocking the recycling of bile acids through inhibition of IBAT, thereby reducing bile acids systemically and in the liver. Volixibat is currently being evaluated in Phase 2b studies for primary sclerosing cholangitis (PSC) (VISTAS study), and primary biliary cholangitis (PBC) (VANTAGE study). In 2026, Mirum shared that the Phase 2b VISTAS study of volixibat in PSC met its primary endpoint, with statistically significant and clinically meaningful reductions in pruritus observed in patients treated with volixibat. Volixibat’s safety profile in the study was generally consistent with the known effects of IBAT inhibition. In 2024, Mirum announced positive interim results from the Phase 2b VANTAGE study of volixibat in PBC. No new safety signals were observed in the study. Volixibat has been granted FDA Breakthrough Therapy designation for the treatment of PBC. About Brelovitug Brelovitug is an investigational, highly potent, pan-genotypic, fully human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets the surface antigen (anti-HBsAg) on both the hepatitis delta virus (HDV) and the hepatitis B virus (HBV). Brelovitug is designed to neutralize and remove hepatitis B and hepatitis D virions and deplete HBsAg-containing subviral particles. Brelovitug has FDA Breakthrough Therapy designation for the treatment of chronic HDV infection and PRIME and Orphan designations from the European Medicines Agency. In 2026, Mirum announced that in the Phase 2b portion of the AZURE-1 study in HDV, treatment with brelovitug demonstrated strong antiviral activity in HDV and achieved the primary composite endpoint of virologic response and alanine aminotransferase (ALT) normalization at Week 24 in both brelovitug dose arms as compared to the delayed treatment arm. Favorable safety and tolerability profiles were observed. Brelovitug is currently being evaluated in the global Phase 3 AZURE clinical program. Mirum owns worldwide rights to brelovitug. About Mirum Pharmaceuticals Mirum Pharmaceuticals (NASDAQ: MIRM) is a leading rare disease company with a global footprint of approved products and a broad pipeline of investigational medicines. Purpose-built to bring forward breakthrough medicines for people with overlooked conditions, Mirum focuses on rare liver and rare genetic diseases, where it has built deep expertise and strong connections to patient communities. The company’s commercial portfolio includes LIVMARLI® (maralixibat) for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC), CHOLBAM® (cholic acid) for bile-acid synthesis disorders, and CTEXLI® (chenodiol) for cerebrotendinous xanthomatosis (CTX). Mirum’s clinical-stage pipeline includes volixibat, an IBAT inhibitor in late-stage development for primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC), brelovitug, a fully human monoclonal antibody in late-stage development for chronic hepatitis delta virus (HDV), zilurgisertib, an ALK2 inhibitor under regulatory review with the FDA for fibrodysplasia ossificans progressiva (FOP), and MRM-3379, a PDE4D inhibitor being evaluated for Fragile X syndrome (FXS). Mirum’s success is driven by a team dedicated to advancing high impact medicines through strategic development, disciplined execution and purposeful collaboration across the rare disease ecosystem. Learn more at www.mirumpharma.com and follow Mirum on Facebook, LinkedIn, Instagram and X. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the Company’s planned participation at a scientific congress, Mirum’s continued or advancing leadership in PSC, HDV, and PFIC, the potential benefit of Mirum products and candidates in real world settings versus scientific presentations of data at the EASL Congress 2026, as well as the potential regulatory success of any Mirum development candidates based on such data. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “expected,” “will,” “could,” “would,” “guidance,” “potential,” “continue” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Mirum’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Mirum’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Mirum’s Annual Report for the year ended December 31, 2025, filed with the Securities and Exchange Commission on February 25, 2026, and subsequent filings with the Securities and Exchange Commission, which are available at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Mirum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. |
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Lilly's Retevmo (selpercatinib) demonstrated an 83% reduction in the risk of disease recurrence or death as adjuvant therapy for people with early-stage RET fusion-positive lung cancer | FMP Stock News | |
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Lilly's Retevmo (selpercatinib) demonstrated an 83% reduction in the risk of disease recurrence or death as adjuvant therapy for people with ea |
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2026-06-12 11:52
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2026-06-04 23:10
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Altimmune Touts Pemvidutide Momentum Ahead of Phase 3 MASH Trial | FMP Stock News | |
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MarketBeat Week in Review – 11/4 - 11/8Altimmune NASDAQ: ALT executives said the company is preparing to begin enrolling patients in the second half of the year for a Phase 3 trial of pemvidutide in metabolic dysfunction-associated steatohepatitis, or MASH, while also awaiting data from related alcohol-associated liver disease programs.Speaking at the Jefferies 2026 Global Healthcare Conference, Chief Executive Officer Jerry Durso said Altimmune is in the startup phase of its Phase 3 MASH program and expects patient enrollment to begin later this year. He also pointed to recently presented data at the European Association for the Study of the Liver, or EASL, meeting as strengthening the company’s view of pemvidutide’s potential differentiation in MASH. Get Altimmune alerts: How Altimmune Could Grab a Big Chunk of the GLP-1 Market“It is an exciting year for Altimmune,” Durso said, adding that the company is continuing to build its understanding of what pemvidutide could bring to the MASH population as the market becomes more competitive. Company Highlights EASL Data and Fibrosis Analyses Altimmune’s chief medical officer, Christophe, said the company had a significant presence at EASL and received a “best of EASL” abstract designation for an oral presentation on 48-week data. He said Altimmune also presented data on cardiovascular risk, non-invasive testing and qFibrosis, a second harmonic generation-based analysis of biopsy samples. This Small Cap Wealth Management Stock Could Provide Big ReturnsChristophe said several methods of evaluating fibrosis were directionally consistent, including biological markers such as PRO-C3 and CTX, PathAI’s LiverExplore approach and qFibrosis. “All these different approaches were consistently showing that anti-fibrotic effect of pemvidutide,” he said. He noted that standard histological reading of biopsies can vary among pathologists, especially at 24 weeks, and said Altimmune designed its Phase 3 trial with a 52-week biopsy-based interim analysis partly to address that variability. He said the company’s 48-week Phase 2 data showed a “very strong anti-fibrotic effect.” Phase 3 Trial to Use Biopsy and Non-Invasive Tools Christophe said Altimmune has regulatory alignment with the U.S. Food and Drug Administration and European regulators on the Phase 3 protocol. He said the trial will use MASH assist, an artificial intelligence-supported tool that helps pathologists read digital biopsy images, while pathologists retain final judgment. Altimmune also plans to include qFibrosis as a secondary endpoint in the Phase 3 trial. Christophe emphasized that qFibrosis is not an approved primary endpoint, but said it could complement biopsy-based primary endpoint assessments. The Phase 3 study will include patients with F2 and F3 fibrosis. Christophe said Cohort 1 will include about 990 biopsy-proven F2 and F3 patients and will support the accelerated approval efficacy assessment. A second cohort will be based more heavily on non-invasive tests, or NITs, while also contributing to the safety database needed for accelerated approval. Durso said Altimmune will collect non-invasive test data for all patients, which could position the company to respond if regulators eventually allow NIT-based endpoints in MASH. “We would need the agency to move their position,” Durso said. Executives Emphasize Differentiation in MASH Market Asked about pemvidutide’s potential positioning if approved, Durso said differentiation will be central as more MASH therapies enter the market. He said pemvidutide’s dual mechanism, combining weight loss effects with direct liver activity, could be important for selected patient segments. Durso said GLP-1 monotherapies may become a common first-line option by the time pemvidutide could reach the market, but he argued that durability of treatment and tolerability could be key differentiators. He said in Altimmune’s Phase 2 trial, discontinuation on the 1.8 mg dose was lower than placebo. He also pointed to potential use in patients at risk of sarcopenia and said pemvidutide may fit in the “middle of the treatment cascade,” while other approaches could be used in different patient groups. Durso said the EASL meeting reinforced the company’s view that the balance between glucagon and GLP-1 activity matters. He said Altimmune believes pemvidutide’s balanced ratio and its EuPort domain may contribute to a differentiated tolerability and efficacy profile. Balance Sheet Supports MASH Readout Timeline Chief Financial Officer Greg Weaver said Altimmune has raised capital through two equity offerings this year, including $75 million in January and a more recent $225 million offering. He said the company’s balance sheet is now “north of $500 million.” Weaver said that funding is expected to cover the company’s runway through delivery of MASH results in 2029, while also supporting Phase 2 trials in alcohol use disorder, or AUD, and alcohol-associated liver disease, or ALD. “Going forward, we would focus on non-dilutive options as our preferred go-forward plan,” Weaver said, noting possible strategic investments, debt facility use or an at-the-market program as additional sources of flexibility. AUD and ALD Data Remain Upcoming Catalysts Durso said the company is also looking forward to data from its AUD and ALD programs, calling them an expansion of pemvidutide’s potential into areas of high unmet need. He said AUD data are expected in the third quarter, with ALD enrollment expected to be completed in the third quarter as well. Christophe said pemvidutide may be relevant in AUD and ALD because its GLP-1 activity could address reward and alcohol cravings, while its glucagon activity may address liver-related effects. He said the AUD study will evaluate heavy drinking days, and the company powered the trial around a one-day difference between pemvidutide and placebo. He said the study will also use blood markers, including phosphatidylethanol, or PEth, and will evaluate other endpoints such as days of no drinking and World Health Organization drinking level changes. Durso said Altimmune expects to issue a traditional topline data release for the AUD study in the third quarter. If the data are positive, he said the company would seek interaction with regulators and update its plans. “The company stays extremely focused,” Durso said. “We are in an era of execution.” About Altimmune NASDAQ: ALTAltimmune, Inc is a clinical-stage biopharmaceutical company headquartered in Gaithersburg, Maryland, dedicated to the development of vaccines and immunotherapeutics. The company leverages proprietary technology platforms to create intranasal vaccine candidates and novel therapies targeting liver diseases and metabolic disorders. Altimmune's approach emphasizes the stimulation of both systemic and mucosal immune responses to address unmet medical needs in infectious and chronic conditions. Among its lead programs, NasoVAX is an investigational intranasal influenza vaccine designed to provide broad, long-lasting protection through a single, non-invasive dose. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. Should You Invest $1,000 in Altimmune Right Now?Before you consider Altimmune, you'll want to hear this. MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Altimmune wasn't on the list. While Altimmune currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys. View The Five Stocks Here Thinking about investing in Meta, Roblox, or Unity? Click the link to learn what streetwise investors need to know about the metaverse and public markets before making an investment. Get This Free Report |
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Is Altimmune Worth Buying Ahead of 2026 Catalysts? | FMP Stock News | |
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Key Takeaways ALT expects a Phase III MASH study launch in 2026 and RECLAIM alcohol-use-disorder data in Q3.ALT reported phase IIb results showing sustained MASH resolution and fibrosis-related improvements.ALT ended April 2026 with about $535 million pro forma cash, supporting operations into 2029. Altimmune (ALT - Free Report) is heading into 2026 with a catalyst-heavy calendar tied to pemvidutide, its lead clinical asset. The setup is straightforward: investors are underwriting pivotal execution in metabolic dysfunction-associated steatohepatitis and looking for proof-of-concept in alcohol-related disease programs.That concentration can create outsized upside on good news and sharp downside on missteps. ALT’s Near-Term Setup Centers on Two 2026 EventsThe first key milestone is the planned start of a global phase III registrational study in metabolic dysfunction-associated steatohepatitis in the second half of 2026, targeting patients with moderate-to-severe liver fibrosis. Management expects 52-week data in 2029, but the 2026 start is the gating event that moves pemvidutide into a pivotal setting. The second 2026 catalyst is top-line phase II data from the RECLAIM study in alcohol use disorder, expected in the third quarter of 2026. Enrollment for RECLAIM was completed in November 2025, ahead of schedule, which keeps the timeline intact heading into next year. A third marker investors may watch is enrollment progress in the RESTORE phase II study in alcohol-associated liver disease. Enrollment is expected to be completed by the third quarter of 2026, providing another read on execution even before efficacy data is available. Altimmune’s MASH Thesis Depends on Pivotal ExecutionThe phase III PERFORMA start matters because it is the step that turns phase II signals into a program designed for registration. Altimmune has highlighted alignment with the Food and Drug Administration on key late-stage parameters, which helps reduce design uncertainty as the company moves into PERFORMA. The stakes are high because the company’s value proposition is heavily tied to pemvidutide across multiple indications. That dependence cuts both ways: success can validate a “pipeline in a product” narrative, while failure in a pivotal metabolic dysfunction-associated steatohepatitis program would likely be a major downside catalyst given how central pemvidutide is to the investment case. That binary profile is also why 2026 is so important. Even without clinical readouts from PERFORMA in 2026, simply initiating the study on time can support confidence that the timeline toward 2029 data remains credible. ALT’s Phase II Evidence Investors Are Leaning OnIn the phase IIb IMPACT study, pemvidutide delivered statistically significant metabolic dysfunction-associated steatohepatitis resolution without worsening fibrosis at 24 weeks, and that response was sustained through 48 weeks. The company also pointed to clear signs of reducing liver scarring by 48 weeks, alongside continued improvement in markers of liver damage and inflammation. Top-line 48-week results highlighted statistically significant reductions versus placebo in non-invasive markers of liver fibrosis, including Enhanced Liver Fibrosis and liver stiffness, with improvements that deepened from the 24-week mark. The dataset also included metabolic benefits, reductions in liver fat and inflammation markers, and meaningful weight loss. Notably, the higher-dose group (1.8 mg) showed weight reduction through 48 weeks without plateauing, while tolerability remained favorable with low discontinuation rates and no serious treatment-related adverse events reported. Altimmune’s Cash Runway Into 2029 Lowers Timing RiskAltimmune’s financial position improved into the first quarter of 2026, with cash, cash equivalents and short-term investments of $332 million as of March 31, 2026 versus $274 million as of Dec. 31, 2025. The company raised $75 million in a registered direct offering and $8 million via an at-the-market program in January to February 2026 and then completed an oversubscribed public offering in April 2026 with $225 million in gross proceeds. Pro forma cash was roughly $535 million as of April 30, 2026. Management expects that cash runway to support operations into 2029, which can lower timing risk by reducing near-term funding pressure as the company advances phase III plans in metabolic dysfunction-associated steatohepatitis and continues its phase II alcohol use disorder and alcohol-associated liver disease trials. ALT’s Dilution and Financing Overhang Still ExistsEven with a strengthened balance sheet, Altimmune remains a pre-revenue clinical-stage biotech with no marketed products, which keeps external financing central to its operating model. That reality can translate into dilution risk over time. The company has indicated it may still raise additional funds if market conditions are favorable, a reminder that opportunistic capital raises can remain part of the story even with a longer runway. Altimmune’s Competition Checklist for BuyersCompetition is a key constraint on upside across all three target areas. In metabolic dysfunction-associated steatohepatitis, pemvidutide faces a crowded field spanning GLP-1 drugs and combination incretins, FGF-21 therapies, thyroid hormone receptor beta agonists, and other emerging mechanisms. Major competitors include Novo Nordisk (NVO - Free Report) and Eli Lilly (LLY - Free Report) , alongside metabolic dysfunction-associated steatohepatitis-focused developers such as Madrigal Pharmaceuticals (MDGL - Free Report) and Viking Therapeutics (VKTX). In alcohol-associated liver disease, large pharmaceutical companies are pursuing multiple approaches, including FGF-21, GLP-1 and RNA-based programs. In alcohol use disorder, pemvidutide would compete with approved options like Vivitrol as well as generic therapies including naltrexone and acamprosate. The net effect is that even strong data may not automatically translate into clear commercial leadership. ALT’s Valuation Snapshot and What It ImpliesOn a relative basis, the stock has been framed through trailing 12-month book value per share. ALT recently traded at 1.24 times trailing book value, compared with 1.39 times for the Zacks sub-industry, 3.71 times for the Zacks sector, and 8.01 times for the S&P 500. Over the past five years, the book value multiple has ranged from 0.71 times to 5.25 times, with a five-year median of 2.34 times. That context suggests the current multiple sits below the longer-term midpoint, but still within a historical band. The stated $3 price target approach is tied to a 1.4 times trailing 12-month book value multiple. In practical terms, that framework implies expectations for performance that tracks more “in-line” outcomes than a high-conviction upside scenario, placing even more emphasis on 2026 execution as the driver of sentiment. Altimmune’s Zacks RankALT currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. |
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ALT and the Rise of Dual Agonists Targeting Liver Disease | FMP Stock News | |
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Key Takeaways ALT positions pemvidutide as a dual glucagon/GLP-1 therapy targeting multiple liver-disease pathways.ALT reported sustained MASH resolution and fibrosis-marker improvements through 48 weeks.ALT expects a Phase III MASH start and AUD phase II data in 2026, with ALD enrollment progressing. Altimmune (ALT - Free Report) is trying to ride a clear shift in liver drug development. Programs are increasingly designed to hit multiple pathways at once, rather than relying on a single lever like weight loss alone. For Altimmune that approach centers on pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist positioned as a “pipeline in a product” across several liver-related settings.The next year matters because it puts this strategy into real-world execution. With pivotal planning in MASH and readouts approaching in alcohol-related conditions, 2026 will help determine whether multi-mechanism liver therapies can translate into durable, clinically meaningful outcomes. ALT’s Thesis Fits a Shift Toward Multi-Pathway TherapiesLiver diseases such as metabolic dysfunction-associated steatohepatitis (MASH) are not single-driver problems. They involve fat accumulation, inflammatory signaling, and progressive fibrosis. That biology has pushed drug development toward combinations and multi-mechanism assets, including dual and even triple agonist designs. Pemvidutide is Altimmune’s entry into this shift. The company’s core claim is that balanced glucagon plus GLP-1 activity in one molecule can address liver biology directly while also improving metabolic factors that contribute to disease progression. Altimmune’s Differentiation Claim vs GLP-1 AloneAltimmune’s differentiation argument starts with the liver’s central role in glucagon signaling. In its framing, glucagon works directly on the liver and may help reduce liver fat, inflammation, and scarring. GLP-1, by contrast, is primarily tied to appetite reduction and weight loss, with potential anti-inflammatory benefits as well. The point is not that GLP-1-driven weight loss is irrelevant. Instead, Altimmune is positioning glucagon activity as additive, aiming to push beyond weight loss alone and more directly influence hepatic fat and fibrosis-related pathways that matter for long-term disease modification. ALT’s Data That Supports “Differentiated” PositioningThe company’s 48-week phase IIb MASH dataset is the backbone of that positioning. Pemvidutide showed statistically significant MASH resolution without worsening of fibrosis at 24 weeks, and the effect was sustained through 48 weeks. More importantly for the “differentiated” narrative, multiple non-invasive markers associated with fibrosis and liver stiffness improved versus placebo, and the benefits deepened from 24 to 48 weeks, which Altimmune frames as evidence of sustained antifibrotic activity over time. Safety and tolerability were also described as favorable, with low discontinuation rates and no serious treatment-related adverse events reported. The higher 1.8 mg dose group continued to lose weight through 48 weeks without plateauing, supporting a profile that could keep improving with longer treatment. Altimmune’s 2026 Milestones as Trend Validation PointsThe next major test is the planned global phase III registrational PERFORMA study in MASH patients with moderate-to-severe liver fibrosis. Altimmune expects to initiate the study in the second half of 2026, following alignment with the FDA on key parameters for late-stage development. In parallel, pemvidutide is being evaluated in alcohol use disorder (AUD), with top-line phase II data from the RECLAIM study expected in the third quarter of 2026. Enrollment was completed in November 2025, ahead of schedule, which reduces one common source of timeline slippage. If these milestones land cleanly, they would reinforce investor interest in dual-agonist liver programs that can credibly claim multi-pathway impact, not just metabolic improvements. ALT’s Alcohol-Related Disease Expansion Could Broaden the StoryAltimmune is also building a second leg to the story in alcohol-related conditions. The company is running a phase II program in alcohol-associated liver disease (ALD) as well as the phase II AUD trial, framing both as areas of significant unmet need with commercial potential. Operationally, the ALD RESTORE phase II study began in July 2025, and enrollment is expected to be completed by the third quarter of 2026. Together with the AUD readout, these programs support the “pipeline in a product” strategy by extending the same mechanism into adjacent, liver-relevant indications. Altimmune’s Partnering Takeover Angle in a Crowded FieldThe competitive landscape is crowded. In MASH, Altimmune is up against GLP-1 leaders such as Novo Nordisk (NVO - Free Report) and Eli Lilly (LLY - Free Report) , as well as a wide range of mechanisms and combination strategies from large pharma and MASH-focused players. NVO and LLY currently carry a Zacks Rank #3 (Hold). Against that backdrop, the company is framed as an attractive licensing or takeover candidate if it keeps executing and the differentiated profile holds up in larger studies. The counterweight is concentration risk: Altimmune remains heavily dependent on pemvidutide, and a phase III failure in MASH would be a major blow. ALT’s Key Watch Items for Trend InvestorsFor investors following the growing shift toward multi-pathway liver therapies, several key milestones will be important to watch. These include the timing of Phase III initiation and the outcome of FDA interactions as Altimmune finalizes the PERFORMA study design. Investors will also be focused on enrollment progress across ongoing trials, including the completion of ALD enrollment and the timely release of top-line data from the AUD study. Another area of attention is manufacturing preparedness, as Altimmune has already secured clinical supply and expects its production process to be scalable to support potential global Phase III needs. Finally, the competitive landscape remains an important consideration, particularly as rapidly advancing GLP-1 combination therapies and other novel mechanisms could narrow pemvidutide’s differentiation and increase the standard required to support best-in-class positioning.Bottom of Form In a field where narrative advantage can disappear quickly, execution and durability of effect will decide whether ALT’s dual-agonist thesis becomes a template or just another crowded contender. Altimmune’s Zacks RankALT currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. |
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ALT Stock Guide to Pemvidutide's MASH, AUD and ALD Setup | FMP Stock News | |
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Key Takeaways ALT's pemvidutide showed significant MASH resolution in phase IIb, sustained through 48 weeks.ALT plans to start the global Phase III PERFORMA study in the second half of 2026.ALT expects 2026 phase II data in alcohol use disorder and alcohol-associated liver disease. Altimmune (ALT - Free Report) is building its investment case around a single clinical asset with multiple shots on goal in liver disease. Pemvidutide sits at the center of that thesis, with mid-stage data in metabolic dysfunction-associated steatohepatitis and active studies in alcohol-related conditions.For investors, the story is simple: execution on the next wave of clinical milestones, paired with enough capital to reach them, can define the stock’s setup into 2026 and beyond. ALT’s Liver Disease Focus and Why It MattersAltimmune is a late clinical-stage biotechnology company focused on therapies for liver diseases. The company is incorporated in Delaware and headquartered in Gaithersburg, MD. It has not generated product sales revenue to date. Operations have been funded through equity, debt and grants, leaving the business reliant on external capital while it advances clinical development. That funding model matters because the value of the equity is closely tied to clinical progress, particularly progress tied to pemvidutide. With revenues still minimal and inconsistent, the stock can be sensitive to trial outcomes and timelines. Altimmune’s Pemvidutide Is a “Pipeline in a Product”Pemvidutide is Altimmune’s lead candidate and the company’s core value driver. It is being developed across three serious liver-related indications: metabolic dysfunction-associated steatohepatitis, alcohol use disorder, and alcohol-associated liver disease. Management has positioned pemvidutide as a “pipeline in a product” because the same molecule is intended to address multiple disease settings that share metabolic and hepatic injury pathways. The company has also indicated it may evaluate additional indications that leverage pemvidutide’s profile. This concentration creates leverage both ways. A successful pivotal program in metabolic dysfunction-associated steatohepatitis can expand strategic options, including partnering interest, but the company is also heavily dependent on one drug. ALT’s Dual Glucagon and GLP-1 Design in Plain EnglishPemvidutide is designed as a balanced 1:1 dual agonist that activates both glucagon and glucagon-like peptide-1 receptors. Altimmune’s thesis is that combining these two pathways in a single molecule can improve liver and metabolic outcomes more broadly than a single-pathway approach. In plain terms, glucagon activity is intended to work directly on the liver and may help reduce liver fat, inflammation, and scarring. The glucagon-like peptide-1 component is intended to support weight loss by reducing appetite, with potential anti-inflammatory benefits as well. Altimmune believes that pairing these effects can address multiple aspects of liver disease at once, while also driving weight loss that can matter clinically for patients with metabolic dysfunction-associated steatohepatitis. Altimmune’s EuPort Tech and Tolerability AnglePemvidutide uses Altimmune’s proprietary EuPort technology, which is designed to slow how the drug is absorbed. The company’s rationale is that slower absorption may improve tolerability. Altimmune has highlighted the potential for reduced gastrointestinal side effects, a common challenge with therapies that act on glucagon-like peptide-1 biology. Better tolerability can support persistence on therapy, which can be important for longer-duration liver endpoints. The company has also pointed to simple dosing as a potential adherence advantage versus more complex injectable regimens, which could matter if pemvidutide moves into larger, global trials. ALT’s MASH Data Readout and the Phase III PathIn its phase IIb IMPACT study, pemvidutide achieved statistically significant metabolic dysfunction-associated steatohepatitis resolution without worsening of fibrosis at 24 weeks, and the response was sustained through 48 weeks. By 48 weeks, Altimmune reported signs consistent with antifibrotic activity, alongside continued improvement in markers tied to liver damage and inflammation, with the added benefit of weight loss. Altimmune has stated it reached alignment with the Food and Drug Administration on key parameters for a late-stage study. The company expects to initiate the global phase III registrational PERFORMA study in the second half of 2026, with 52-week data anticipated in 2029. Altimmune’s AUD and ALD Catalysts for 2026Beyond metabolic dysfunction-associated steatohepatitis, pemvidutide is being evaluated in separate phase II programs in alcohol-related disease, which Altimmune views as significant unmet-need markets. For alcohol use disorder, the RECLAIM phase II study completed enrollment in November 2025. Altimmune expects top-line data in the third quarter of 2026, setting up a clear catalyst window next year. For alcohol-associated liver disease, the RESTORE phase II study began in July 2025, and enrollment is expected to be completed by the third quarter of 2026. Together, these readouts broaden the 2026 news flow beyond the metabolic dysfunction-associated steatohepatitis pivotal setup. ALT’s Regulatory Tailwinds and What They SignalThe Food and Drug Administration granted Fast Track designation to pemvidutide for metabolic dysfunction-associated steatohepatitis and alcohol use disorder, and Breakthrough Therapy Designation for metabolic dysfunction-associated steatohepatitis. These designations generally reflect the seriousness of the conditions and the unmet medical need, while also signaling that regulators see enough potential benefit to support development efficiency. They do not remove execution risk, but they can help keep timelines clearer as trials scale. Competition remains intense, including large players such as Novo Nordisk (NVO - Free Report) and Eli Lilly (LLY - Free Report) , both currently carrying Zacks Rank #3 (Hold). For ALT, the near-term focus is whether pemvidutide’s multi-indication strategy translates into durable, registrational-quality outcomes across liver disease. Altimmune’s Zacks RankALT currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. |
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Altimmune Sets Pemvidutide's Phase 3 MASH Playbook as AUD Data Near | FMP Stock News | |
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MarketBeat Week in Review – 11/4 - 11/8Altimmune NASDAQ: ALT management used an appearance at the Goldman Sachs Global Healthcare Conference to outline the company’s focus on pemvidutide, its lead metabolic and liver disease drug candidate, and to discuss the planned Phase 3 program in metabolic dysfunction-associated steatohepatitis, or MASH.Jerry Durso, Altimmune’s president, CEO and chairman, said pemvidutide was the primary reason he joined the company, first as a board member last year and then as CEO at the beginning of this year. Durso said the drug’s combination of GLP-1 activity and glucagon activity made it “uniquely suited for liver disease,” with the GLP component targeting metabolic factors such as weight loss and the glucagon component providing what he described as direct activity on the liver. Get Altimmune alerts: How Altimmune Could Grab a Big Chunk of the GLP-1 MarketDurso also highlighted pemvidutide’s proprietary EuPort domain, which he said could be an important contributor to tolerability. He said Altimmune’s current strategy emphasizes liver disease as the primary focus for the asset. Management Highlights Strategic Priorities Durso said Altimmune’s priorities over the past year have included strengthening the company’s management team, preparing for late-stage development, refining how it communicates pemvidutide’s potential differentiation and positioning the company financially for a Phase 3 program. This Small Cap Wealth Management Stock Could Provide Big ReturnsGreg Weaver, Altimmune’s CFO, said the company has raised “approaching $500 million” over the past 18 months. He noted that MASH trials can cost in the range of $400 million and said Altimmune is now “well-positioned” with additional optionality if needed. Weaver also said investor engagement and clearer messaging around Altimmune’s focus on MASH and liver disease have been important as the company prepares for its next stage of development. Pemvidutide’s Role in a Developing MASH Market Durso said the MASH treatment market is maturing, with the first approved therapies now available and more mechanisms expected to enter the market. He said the disease’s complexity likely means multiple mechanisms and combinations will be needed over time. Durso said Altimmune is thinking about where pemvidutide could fit in a future market with more treatment options, rather than only the current market. He pointed to potential patient segments including those who may have difficulty tolerating other therapies, patients at risk of sarcopenia and patients who may benefit from a simpler titration schedule. He also said pemvidutide could become a potential combination partner because of what the company believes could be a favorable safety and tolerability profile, along with a simple titration approach. Phase 2 Data and Differentiation Durso reviewed prior Phase 2 MASH results, saying pemvidutide showed early activity on MASH resolution at 24 weeks. While the company did not see statistical significance on fibrosis by biopsy at 24 weeks, Durso said non-invasive tests suggested antifibrotic activity was already emerging. At 48 weeks, he said Altimmune saw improvement across non-invasive tests, including FibroScan and ELF, and that the company believes 52 weeks is the appropriate time point for a biopsy-based fibrosis readout in Phase 3. Durso noted there was no biopsy at 48 weeks in the Phase 2 program. Durso also highlighted adherence and tolerability, saying pemvidutide had an “extremely low discontinuation rate” in the 48-week data and that more patients stayed on the 1.8 milligram dose than on placebo. He compared that with Phase 2 MASH data for survodutide, saying that program had a discontinuation rate above 20%. Durso said pemvidutide has a one-to-one ratio of glucagon and GLP-1 agonism, while survodutide is more weighted toward GLP-1 activity. He said the ratio, the molecule itself and the EuPort domain may all be relevant to tolerability and differentiation within the glucagon/GLP-1 class. Phase 3 MASH Trial Plans Altimmune’s planned Phase 3 MASH program will include a 52-week interim histology readout that Durso said could support an accelerated approval filing, along with a longer-term outcomes component. The study will evaluate two doses of pemvidutide: 1.8 milligrams and 2.4 milligrams. Durso said the 1.8 milligram dose is supported by the Phase 2 data, while the 2.4 milligram dose offers potential upside on efficacy and in certain subpopulations. The Phase 3 trial will include a simple one- or two-step titration over four or eight weeks, depending on dose. The study will include biopsy-proven F2 and F3 MASH patients, as well as a separate cohort of NIT-screened F2 and F3 patients. Durso said the biopsy cohort will support the 52-week efficacy analysis, while both cohorts together will contribute to the safety database and longer-term outcomes analysis. Durso said the trial will be the first Phase 3 program to use the AIM-MASH AI Assist tool, which is intended to support pathologists in histology reads and reduce variability. He said Altimmune continues to guide for patient enrollment to begin in the second half of the year, with a readout anticipated in 2029. He said MASH trials typically take 18 to 24 months to enroll, and Altimmune is targeting the lower end of that range. Alcohol Use Disorder and Alcohol-Associated Liver Disease Durso also discussed pemvidutide’s development in alcohol use disorder, or AUD, and alcohol-associated liver disease, or ALD. He said Altimmune sees a rationale for the drug in these areas because it may address both drinking behavior through GLP-1-related effects on craving and liver-related effects through its glucagon activity. The company expects Phase 2 data in AUD next quarter. Durso said the primary endpoint is a reduction in the number of heavy drinking days, with additional measures including liver enzymes, weight and secondary endpoints such as World Health Organization classification. Durso said there are about 12 million people with AUD and roughly half that number with ALD, with no approved drugs in ALD and only older options in AUD. Weaver said that if Phase 3 development in AUD or ALD is supported by the data, Altimmune would likely prefer non-dilutive financing options, which could include a partner, strategic transaction or regional arrangement. About Altimmune NASDAQ: ALTAltimmune, Inc is a clinical-stage biopharmaceutical company headquartered in Gaithersburg, Maryland, dedicated to the development of vaccines and immunotherapeutics. The company leverages proprietary technology platforms to create intranasal vaccine candidates and novel therapies targeting liver diseases and metabolic disorders. Altimmune's approach emphasizes the stimulation of both systemic and mucosal immune responses to address unmet medical needs in infectious and chronic conditions. Among its lead programs, NasoVAX is an investigational intranasal influenza vaccine designed to provide broad, long-lasting protection through a single, non-invasive dose. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. Should You Invest $1,000 in Altimmune Right Now?Before you consider Altimmune, you'll want to hear this. MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Altimmune wasn't on the list. While Altimmune currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys. View The Five Stocks Here The AI boom is creating opportunities across semiconductors, cloud computing, enterprise software, infrastructure, cybersecurity, and automation. Inside this report, you’ll find 10 companies positioned to benefit as artificial intelligence moves from hype to real-world deployment and becomes a core growth driver for corporate America. Get This Free Report |
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Altimmune, Inc. (ALT) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript | FMP Stock News | |
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Altimmune, Inc. (ALT) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript |
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2026-06-12 11:52
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2026-04-04 04:08
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Structure Therapeutics Inc. Sponsored ADR (NASDAQ:GPCR) Given Consensus Rating of “Moderate Buy” by Brokerages | FMP Stock News | |
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Posted by Defense World Staff on Apr 4th, 2026Shares of Structure Therapeutics Inc. Sponsored ADR (NASDAQ:GPCR – Get Free Report) have been given a consensus recommendation of “Moderate Buy” by the eighteen research firms that are currently covering the firm, Marketbeat Ratings reports. Two equities research analysts have rated the stock with a sell rating, one has issued a hold rating, thirteen have issued a buy rating and two have assigned a strong buy rating to the company. The average twelve-month target price among analysts that have issued ratings on the stock in the last year is $110.00. Several brokerages recently weighed in on GPCR. The Goldman Sachs Group upgraded Structure Therapeutics to a “strong-buy” rating in a research report on Tuesday, January 20th. Guggenheim upped their price target on Structure Therapeutics from $90.00 to $140.00 and gave the company a “buy” rating in a research note on Tuesday, January 20th. BMO Capital Markets set a $145.00 price target on Structure Therapeutics and gave the stock an “outperform” rating in a report on Tuesday, March 17th. HC Wainwright cut their price objective on Structure Therapeutics from $114.00 to $100.00 and set a “buy” rating for the company in a research report on Monday, March 16th. Finally, Citigroup reaffirmed an “outperform” rating on shares of Structure Therapeutics in a research report on Friday, December 12th. Get Our Latest Stock Analysis on Structure Therapeutics Structure Therapeutics Stock Performance Shares of GPCR stock opened at $53.48 on Friday. Structure Therapeutics has a twelve month low of $13.22 and a twelve month high of $94.90. The stock has a market cap of $3.79 billion, a price-to-earnings ratio of -67.70 and a beta of -1.17. The company’s 50-day moving average price is $64.67 and its 200-day moving average price is $52.40. Structure Therapeutics (NASDAQ:GPCR – Get Free Report) last posted its earnings results on Thursday, February 26th. The company reported ($0.49) earnings per share for the quarter, missing the consensus estimate of ($0.35) by ($0.14). As a group, equities research analysts predict that Structure Therapeutics will post -0.82 EPS for the current year. Hedge Funds Weigh In On Structure Therapeutics Several large investors have recently made changes to their positions in the stock. CWM LLC lifted its stake in Structure Therapeutics by 35.2% during the fourth quarter. CWM LLC now owns 480 shares of the company’s stock worth $33,000 after purchasing an additional 125 shares in the last quarter. HighTower Advisors LLC raised its holdings in shares of Structure Therapeutics by 3.6% in the 4th quarter. HighTower Advisors LLC now owns 9,320 shares of the company’s stock valued at $648,000 after buying an additional 320 shares during the period. State of Wyoming raised its holdings in shares of Structure Therapeutics by 29.7% in the 4th quarter. State of Wyoming now owns 1,761 shares of the company’s stock valued at $122,000 after buying an additional 403 shares during the period. PNC Financial Services Group Inc. lifted its stake in Structure Therapeutics by 9.4% during the 3rd quarter. PNC Financial Services Group Inc. now owns 4,828 shares of the company’s stock worth $135,000 after acquiring an additional 413 shares in the last quarter. Finally, China Universal Asset Management Co. Ltd. boosted its holdings in Structure Therapeutics by 4.3% during the 4th quarter. China Universal Asset Management Co. Ltd. now owns 10,888 shares of the company’s stock valued at $757,000 after acquiring an additional 444 shares during the period. 91.78% of the stock is currently owned by institutional investors and hedge funds. About Structure Therapeutics (Get Free Report) Structure Therapeutics (NASDAQ:GPCR) is a clinical‐stage biotechnology company focused on the discovery and development of oral small‐molecule therapies that target G protein‐coupled receptors (GPCRs). Leveraging advances in structural biology, computational chemistry and medicinal chemistry, the company’s scientific platform is designed to optimize binding interactions and pharmacokinetic properties, with the goal of delivering innovative treatments for metabolic and inflammatory disorders. The company’s pipeline comprises multiple programs in various stages of preclinical and clinical development. Read More Five stocks we like better than Structure Therapeutics Receive News & Ratings for Structure Therapeutics Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Structure Therapeutics and related companies with MarketBeat.com's FREE daily email newsletter. « PREVIOUS HEADLINEDHT Holdings, Inc. (NYSE:DHT) Receives Average Rating of “Moderate Buy” from Analysts NEXT HEADLINE »American National Bank & Trust Has $2.71 Million Stock Holdings in Duke Energy Corporation $DUK |
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2026-06-12 11:52
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2026-04-06 04:43
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Capricorn Fund Managers Ltd Invests $17.57 Million in Structure Therapeutics Inc. Sponsored ADR $GPCR | FMP Stock News | |
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Posted by Defense World Staff on Apr 6th, 2026Capricorn Fund Managers Ltd bought a new stake in shares of Structure Therapeutics Inc. Sponsored ADR (NASDAQ:GPCR – Free Report) during the fourth quarter, according to the company in its most recent disclosure with the Securities and Exchange Commission. The fund bought 252,600 shares of the company’s stock, valued at approximately $17,568,000. Structure Therapeutics makes up about 4.2% of Capricorn Fund Managers Ltd’s investment portfolio, making the stock its 3rd largest holding. Capricorn Fund Managers Ltd owned approximately 0.42% of Structure Therapeutics as of its most recent SEC filing. Other institutional investors also recently bought and sold shares of the company. E. Ohman J or Asset Management AB bought a new stake in Structure Therapeutics during the 4th quarter valued at approximately $314,000. Gilbert & Cook Inc. bought a new position in shares of Structure Therapeutics in the 4th quarter worth approximately $395,000. JPMorgan Chase & Co. raised its position in shares of Structure Therapeutics by 37.0% in the 3rd quarter. JPMorgan Chase & Co. now owns 58,148 shares of the company’s stock worth $1,628,000 after acquiring an additional 15,706 shares in the last quarter. Alyeska Investment Group L.P. purchased a new position in shares of Structure Therapeutics in the 3rd quarter valued at approximately $6,856,000. Finally, Paradigm Biocapital Advisors LP bought a new stake in shares of Structure Therapeutics during the third quarter valued at approximately $10,440,000. 91.78% of the stock is owned by institutional investors. Structure Therapeutics Stock Performance Shares of GPCR stock opened at $53.48 on Monday. The company has a market capitalization of $3.79 billion, a price-to-earnings ratio of -67.70 and a beta of -1.17. Structure Therapeutics Inc. Sponsored ADR has a one year low of $13.22 and a one year high of $94.90. The company’s 50-day moving average is $64.67 and its 200 day moving average is $52.83. Structure Therapeutics (NASDAQ:GPCR – Get Free Report) last issued its earnings results on Thursday, February 26th. The company reported ($0.49) earnings per share (EPS) for the quarter, missing the consensus estimate of ($0.35) by ($0.14). As a group, research analysts predict that Structure Therapeutics Inc. Sponsored ADR will post -0.82 earnings per share for the current fiscal year. Analysts Set New Price Targets Several brokerages recently weighed in on GPCR. JPMorgan Chase & Co. upped their price target on Structure Therapeutics from $65.00 to $105.00 and gave the stock an “overweight” rating in a research note on Thursday, January 22nd. Guggenheim boosted their target price on shares of Structure Therapeutics from $90.00 to $140.00 and gave the company a “buy” rating in a report on Tuesday, January 20th. The Goldman Sachs Group raised shares of Structure Therapeutics to a “strong-buy” rating in a research report on Tuesday, January 20th. Weiss Ratings reiterated a “sell (d-)” rating on shares of Structure Therapeutics in a research note on Thursday, January 22nd. Finally, Jefferies Financial Group set a $125.00 price target on shares of Structure Therapeutics and gave the company a “buy” rating in a research report on Thursday, December 11th. Two equities research analysts have rated the stock with a Strong Buy rating, thirteen have given a Buy rating, one has assigned a Hold rating and two have given a Sell rating to the company. According to MarketBeat.com, Structure Therapeutics currently has a consensus rating of “Moderate Buy” and an average target price of $110.00. Read Our Latest Stock Report on Structure Therapeutics About Structure Therapeutics (Free Report) Structure Therapeutics (NASDAQ:GPCR) is a clinical‐stage biotechnology company focused on the discovery and development of oral small‐molecule therapies that target G protein‐coupled receptors (GPCRs). Leveraging advances in structural biology, computational chemistry and medicinal chemistry, the company’s scientific platform is designed to optimize binding interactions and pharmacokinetic properties, with the goal of delivering innovative treatments for metabolic and inflammatory disorders. The company’s pipeline comprises multiple programs in various stages of preclinical and clinical development. Further Reading Five stocks we like better than Structure Therapeutics Receive News & Ratings for Structure Therapeutics Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Structure Therapeutics and related companies with MarketBeat.com's FREE daily email newsletter. « PREVIOUS HEADLINECapricorn Fund Managers Ltd Buys 247,000 Shares of Roivant Sciences Ltd. $ROIV NEXT HEADLINE »Guardant Health, Inc. $GH is Capricorn Fund Managers Ltd’s 6th Largest Position |
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2026-06-12 11:52
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2026-04-08 16:14
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Structure Therapeutics: The Oral Obesity Inflection, Best-In-Class Efficacy Meets Biased-Agonism Safety Moat | FMP Stock News | |
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Structure Therapeutics (GPCR) is initiated with a BUY rating and $110 price target, reflecting a 101% upside from current levels. Aleniglipron, GPCR's oral GLP-1 agonist, demonstrated 16.3% placebo-adjusted weight loss at 44 weeks with superior safety and manufacturing cost advantages. GPCR's $1.4B cash position provides runway through 2028 and a valuation floor of $23.10 in a bear scenario. |
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