Track market-moving stories before they get noisy

Posted by Defense World Staff on Apr 6th, 2026

Capricorn 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.

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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.

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.

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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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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.

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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.

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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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.

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Ticker Change Reflects the Company's Continued Evolution Across Payments, Tokenization and AI-Driven Infrastructure

LAS 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

May 13, 2026 07:15 ET  | Source: Altimmune, Inc

Abstract 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.

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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]

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.

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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].

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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%.

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/

May 27, 2026 08:30 ET  | Source: Altimmune, Inc

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 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]

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.

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.

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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].

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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.

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.

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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.

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Posted by Defense World Staff on Apr 4th, 2026

Shares 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.

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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.

Weight loss drugs are big business, with the GLP-1 receptor agonist market expected to nearly triple in size to $185 billion by 2033, a compound annual growth rate of about 12.4%. Although increasingly a global medical phenomenon, the bulk of the market still exists in the United States, and domestic investors can get in on the action by targeting companies that manufacture these powerful drugs.

It's a mistake to assume that all sales of GLP-1 drugs will be limited to the major products Ozempic or Wegovy, both manufactured by pharma giant Novo Nordisk A/S NYSE: NVO. The demand in this relatively new space is so great that a growing number of alternatives are quickly emerging, despite the seeming dominance of a few major players. Below, we'll look at a standalone, lesser-known biotech developer with a promising alternative in the works, as well as two exchange-traded funds (ETFs) that can give broad and diversified exposure to the whole industry at once.

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A Pivot Toward GLP-1 Drugs Could Be Transformational for Structure TherapeuticsStructure Therapeutics NASDAQ: GPCR is a biotechnology company developing drugs focused on G protein-coupled receptors, or GPCRs. The firm has traditionally targeted new treatments for metabolic and inflammatory diseases like fibrosis or nonalcoholic steatohepatitis.

Structure Therapeutics Today

GPCR

Structure Therapeutics

$43.30 +1.77 (+4.26%)

As of 06/11/2026 04:00 PM Eastern

52-Week Range$15.80▼

$94.90Price Target$106.75

The company has more recently followed the trend toward GLP-1 drugs as well, and its aleniglipron has recently demonstrated 16.3% weight loss, adjusted for certain trial factors, and could beat out some competitors in terms of safety and manufacturing costs.

Though Structure is not currently profitable, it does have a solid cash position of about $1.4 billion. This should give it ample runway over the next several quarters as it continues to develop aleniglipron, with the drug candidate moving toward a critical Phase 3 trial.

Analysts have flagged Structure for its strong potential based on the promise of aleniglipron. Ratings for GPCR stock include 15 out of 18 ratings of Buy or equivalent. Shares have been hit fairly hard so far this year, declining by 20% in the midst of a challenging set of external factors, but bullishness still wins the day across Wall Street: with a consensus price target of $110, Structure's share price could more than double.

The First GLP-1 Agonist ETF Is Building a Track Record of SuccessInvestors should know that there is massive potential in the GLP-1 space thanks to the recent proliferation of ETFs dedicated to this investment strategy. The Roundhill GLP-1 & Weight Loss ETF NASDAQ: OZEM was an early leader in this space, launching in mid-2024. The fund takes a fairly focused approach, targeting about two dozen pharmaceutical companies positioned to benefit from the growth of the GLP-1 agonist industry.

Roundhill GLP-1 & Weight Loss ETF Today

OZEM

Roundhill GLP-1 & Weight Loss ETF

$30.85 +0.96 (+3.21%)

As of 06/11/2026 03:56 PM Eastern

52-Week Range$23.22▼

$37.15Assets Under Management$47.37 million

Novo Nordisk and major rival Eli Lilly & Co. NYSE: LLY feature prominently, accounting for nearly 30% of the portfolio in total. The fund's basket is fairly broad, though, and includes a number of domestic and international names to provide substantial geographical diversification.

Crucially, the fund provides exposure not only to large companies involved in producing or selling GLP-1 therapeutics, but also to those creating other weight loss enablers and even to companies supporting the supply chain vital to production.

As an actively managed fund, OZEM has an expense ratio of 0.59%; this may be high in comparison with ETFs overall but is actually quite competitive relative to other active funds. The fund is quite niche, so it has a modest asset base of some $52 million and relatively low trading volumes. Still, it is up an impressive 45% in the last year, rewarding those investors willing to buy and hold. A modest dividend serves as an added bonus.

Another GLP-1 ETF With a Passive ApproachAn alternative in the GLP-1 ETF space is the Amplify Weight Loss Drug & Treatment ETF NYSEARCA: THNR. In many ways THNR is quite similar to OZEM: this fund also carries an annual fee of 0.59% and tracks roughly two dozen pharma names connected to the GLP-1 agonist market. It also weighs Novo Nordisk and Eli Lilly heavily, although these two companies combine to make up just around a quarter of the portfolio, so there is a bit more room in the case of THNR for access to other companies.

Amplify Weight Loss Drug & Treatment ETF Today

THNR

Amplify Weight Loss Drug & Treatment ETF

$24.53 +0.54 (+2.25%)

As of 06/11/2026 04:10 PM Eastern

52-Week Range$21.70▼

$27.28Assets Under Management$4.08 million

A big difference, though, is that THNR is not an actively managed fund. Rather, it tracks an index of companies in the GLP-1 industry. Its weighting is determined by float-adjusted market cap, and its portfolio is influenced by factors such as market cap weighting and trading volume.

While the basket is rebalanced just four times a year, some investors may find that this passive reflection of the market is more suitable for their interests than an active management approach.

On the other hand, THNR's asset base is tiny, at just $4 million, and its trading volume matches. The fund has returned about 30% in the last year—still roughly on par with the broader market, but well below OZEM.

Should You Invest $1,000 in Roundhill GLP-1 & Weight Loss ETF Right Now?Before you consider Roundhill GLP-1 & Weight Loss ETF, 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 Roundhill GLP-1 & Weight Loss ETF wasn't on the list.

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Reported positive results from aleniglipron Phase 2 ACCESS II study 
with up to 16.3% body weight loss, demonstrating highest efficacy among oral GLP-1RAs
at the 44-week time point and potentially comparable efficacy to injectable GLP1-RAs

Data from ACCESS OLE expected in Q3 2026;
Data from the Body Composition and Type 2 Diabetes/Obesity data expected in Q4 2026

Positive end-of-Phase 2 feedback received from FDA;
aleniglipron Phase 3 initiation on track for Q3 2026

Initial data from Phase 1 single ascending dose (SAD) study of
oral small molecule amylin receptor agonist ACCG-2671 and
initiation of multiple ascending dose (MAD) study expected in Q3 2026;
Phase 1 initiation of second oral amylin candidate ACCG-3535 expected in Q4 2026

Aleniglipron, amylin and combination data to be presented
at the American Diabetes Association (ADA) 86th Scientific Sessions in June 2026

Cash, cash equivalents and short-term investments of $1.5 billion as of March 31, 2026, expected to provide cash runway through the end of 2028

SAN FRANCISCO, May 07, 2026 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today reported financial results for the first quarter ended March 31, 2026, and provided a business update.

“With positive end of Phase 2 feedback received from the FDA for aleniglipron, we are well positioned to start our Phase 3 registrational program for chronic weight management in the third quarter,” said Raymond Stevens, Ph.D., CEO of Structure Therapeutics. “We are also looking forward to our aleniglipron presentation along with presentations on our oral amylin and GLP-1 combination program at the upcoming ADA meeting. With our Phase 1 clinical data for our oral amylin candidate ACCG-2671 anticipated in the third quarter and additional aleniglipron data later this year, our broad portfolio positions us well in the evolving landscape that we believe will favor more accessible oral small molecules, extended maintenance treatment, and fixed dose oral combinations for specific patient populations and expanded indications.”

Recent and Upcoming Milestones

Aleniglipron - Oral Small Molecule Selective Glucagon-Like Peptide 1 (GLP-1) Receptor Agonist for the Treatment of Obesity and Overweight

In March 2026, the Company reported data from the aleniglipron clinical program included 44-week topline data from the Phase 2 ACCESS II study, as well as interim data from body composition study and Phase 2b ACCESS open label extension (OLE) study.

The Phase 2 ACCESS II study demonstrated a placebo-adjusted mean weight loss of 16.3% (39 Ibs; p<0.0001) at the 180 mg dose and 16.0% (37 Ibs; p<0.0001) at the 240 mg dose at 44 weeks.The ongoing ACCESS OLE study achieved continued weight loss up to 16.2% (40.5 lbs) observed with 120 mg dose at 56 weeks.No weight loss plateau was observed in any of the studies. Data from the ACCESS, ACCESS II, Body Composition, and the ACCESS OLE studies provide a strong foundation for the decision to advance aleniglipron into Phase 3 clinical development. The Company expects to report topline results from the ACCESS OLE and Body Composition studies in Q3 and Q4 2026, respectively.

The Company received positive end-of-Phase 2 feedback from the U.S. Food and Drug Administration (FDA) and clear guidance on the Phase 3 program with a starting titration dose of 2.5 mg and the intent to evaluate multiple doses. The Company anticipates initiating the Phase 3 program in Q3 2026.

The Company is also conducting supplementary studies to enhance the competitive profile of aleniglipron, including:

Ongoing study of ACCESS OLE to evaluate the tolerability profile of the dosing regimen starting at the 2.5 mg dose for those previously on placebo and to collect up to 72 weeks of data exposure to aleniglipron, including 180 mg dose. Data are expected in Q3 2026.Ongoing Body Composition study to assess the effect of aleniglipron on body fat loss over a 44-week evaluation period, which includes a 28-week titration period and a starting dose of 2.5 mg and target dose of 180 mg of aleniglipron. These data will be used to inform the size of a sub study into the Phase 3 program. Data are expected in Q4 2026.Ongoing 30-week study in patients with type 2 diabetes mellitus (T2DM) with obesity/overweight and a starting dose of 2.5 mg and target dose of 180 mg of aleniglipron to evaluate the potential for including participants with T2DM in the Phase 3 obesity program. Data are expected in Q4 2026.Ongoing SWITCH study to assess the transition or switching from an approved injectable GLP-1 receptor agonist to once-daily oral aleniglipron for weight loss maintenance. This study assesses different aleniglipron starting doses and weight loss maintenance over 12 weeks. Data are expected in Q4 2026. Oral Small Molecule Amylin Receptor Agonists

In December 2025, the Company advanced ACCG-2671 into a Phase 1 clinical study as the industry’s most advanced oral small molecule amylin therapy for the treatment of obesity. ACCG-2671 is being evaluated in an ongoing single ascending dose (SAD) study to measure safety, tolerability, pharmacokinetics, and food-effect of single ascending doses in healthy adult participants with data anticipated in 2H 2026. In addition, the Company expects to initiate a multiple ascending dose (MAD) study in Q3 2026.In November 2025, the Company declared a second oral small molecule dual amylin calcitonin receptor agonist development candidate, ACCG-3535. ACCG-3535, which is a unique chemical structure compared to ACCG-2671, demonstrated robust food intake suppression and significant, dose-dependent body weight reduction as a monotherapy in diet-induced obese rats. Combination therapy with semaglutide (both concurrently and as a subsequent add-on to semaglutide) resulted in superior weight loss compared to semaglutide or ACCG-3535 monotherapy. The Company expects to initiate a Phase 1 clinical study of ACCG-3535 in Q4 2026. Multiple presentations at ADA, taking place from June 5–8, 2026

Details of the presentations are as follows:

Title: ACCESS Trial: Dose-Ranging Evaluation of Aleniglipron, an Oral Small Molecule Nonpeptide GLP-1RA, Demonstrates Meaningful Weight Reductions in People Living with Obesity and Overweight
Session: Oral Presentations - Human Studies in Obesity Treatment: Emerging Therapeutic Options and Strategies for Decision-Making (1032-OR)
Speaker: Julio Rosenstock, MD, University of Texas Southwestern Medical Center
Date: Friday, June 5: 12:45 p.m. – 1:00 p.m. CT

Title: Safety, Tolerability, and Efficacy of Aleniglipron in Doses up to 240 mg in People Living with Obesity: The Phase 2 ACCESS II Trial
Session: General Poster Session (2637-P)
Date: Monday, June 8: 12:30 p.m. – 1:30 p.m. CT

Title: Exploring a Lower Starting Dose of Aleniglipron, an Oral Small Molecule GLP-1RA, to Improve GI Tolerability in Obesity: Beyond the ACCESS Trials
Session: Late Breaking Poster Session (3101-LB)
Date: Sunday, June 7: 12:30 p.m. – 1:30 p.m. CT

Title: Combination Treatment of Oral Small Molecule GLP-1 Receptor Agonist Aleniglipron and Small Molecule Amylin Receptor Agonist ACCG-2671 Demonstrated Additional Weight Loss than Monotreatment in Obese NHPs
Session: Late Breaking Poster Session (3061-LB)
Date: Sunday, June 7: 12:30 p.m. – 1:30 p.m. CT

Title: Comparison of Conditioned Taste Avoidance Profiles between GLP-1 Peptides, Amylin Peptides, and Small Molecule Amylin Receptor Agonists
Session: Late Breaking Poster Session (3062-LB)
Date: Sunday, June 7: 12:30 p.m. – 1:30 p.m. CT

Additional information about the ADA 2026 Scientific Sessions is available at the ADA meeting website (American Diabetes Association).

First Quarter 2026 Financial Highlights

Cash Position: Cash, cash equivalents and short-term investments totaled $1.5 billion as of March 31, 2026. The Company received $100.0 million in the first quarter of 2026, consisting of an upfront license fee for certain patents that cover a class of oral GLP-1 receptor agonists that is different from aleniglipron. The Company expects its current cash, cash equivalents and short-term investments to fund projected operations and key clinical milestones through the end of 2028. This includes costs related to the ongoing aleniglipron ACCESS OLE, ACCESS II extension study, the supplementary studies, and Phase 3 registrational studies in chronic weight management, but excludes additional costs related to pre-commercialization activities including commercial manufacturing.

Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2026 were $66.5 million, as compared to $42.9 million for the same period in 2025. The increase in R&D expenses was primarily due to increases related to clinical trial costs, preclinical research and development expenses and employee expenses (primarily due to an increase in personnel) to support the advancement of our GLP-1R franchise including aleniglipron.

General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2026 were $22.9 million, as compared to $13.4 million for the same period in 2025. The increase in G&A expenses was primarily due to increases in employee expenses as we expanded our infrastructure to drive and support the growth in our operations and professional services.

Net Loss: Net loss for the first quarter of 2026 totaled $76.0 million, with non-cash share-based compensation expense of $11.6 million, compared to $46.8 million for the same period in 2025 with non-cash share-based compensation expense of $5.9 million.

About Aleniglipron and Structure Therapeutics’ Oral Metabolic Franchise
Aleniglipron (GSBR-1290) is an investigational orally-available, small molecule agonist of the GLP-1 receptor, a validated drug target for the treatment of obesity and T2DM. Through Structure Therapeutics’ structure-based drug discovery platform, aleniglipron was designed to be a biased G Protein-Coupled Receptor (GPCR) agonist, which selectively activates the G-protein signaling pathway. Beyond aleniglipron, Structure Therapeutics is developing next generation oral small molecules including amylin receptor agonists (ACCG-2671 and ACCG-3535), and other combination GLP-1 receptor agonists candidates targeting the glucose-dependent insulinotropic polypeptide (GIP), glucagon and apelin receptors.

About Structure Therapeutics
Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more people living with obesity around the world. For additional information, please visit www.structuretx.com.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: the Company’s future plans and prospects; the expected timing of ACCESS OLE and Body Composition studies data readouts; the planned initiation of the aleniglipron Phase 3 study and the timing thereof; the expected timing of initial data from the Phase 1 study of ACCG-2671; the planned initiation of the ACCG-3535 Phase 1 study and the timing thereof; the belief that data to date from the ACCESS, ACCESS II, Body Composition, and the ACCESS OLE studies support and inform aleniglipron advancement into Phase 3 clinical development; the Company’s anticipated cash runway and uses of cash; any expectations regarding the potential benefits, tolerability and safety profile, accessibility, scalability, combinability, capability, efficacy, convenience, expected effects and future application of aleniglipron; any presumption that topline, interim or preliminary data will be representative of final data or data in later clinical trials. In addition, when or if used in this press release, the words and phrases "anticipated," "believe," "expect," "potential," "to be," "will," and similar expressions and their variants, as they relate to the Company, may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company's forward-looking statements due to a variety of risks and uncertainties, which include, without limitation: risks and uncertainties related to topline results that the Company reports are based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; the preliminary nature of the results due to the length of the study and sample size and the results from earlier clinical studies not necessarily being predictive of future results; potential delays in the commencement, enrollment and completion of the Company's planned Phase 3 clinical program and other clinical studies; disruptions to the operations of the FDA or other U.S. governmental agencies or comparable foreign regulatory authorities caused by funding shortages, leadership changes, or staffing reductions; the Company's ability to advance aleniglipron, ACCG-2671, LTSE-2578, ACCG-3535, and its other therapeutic candidates, obtain regulatory approval of, and ultimately commercialize the Company's therapeutic candidates; competitive products or approaches limiting the commercial value of the Company's product candidates; the timing and results of preclinical and clinical studies; the Company's ability to fund development activities and achieve development goals; the Company's reliance on third parties, including clinical research organizations, manufacturers, suppliers and collaborators, over which it may not always have full control; general geopolitical and macroeconomic conditions, including as a result of tariffs and various global conflicts; the Company's ability to protect its intellectual property; and other risks and uncertainties described in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's latest Annual Report on Form 10-K and future reports the Company may file with the SEC from time to time. 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. The Company 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.

Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
212-915-2577
[email protected]

Jun Yoon
Structure Therapeutics Inc.
[email protected]

Media:
Dan Budwick
1AB
[email protected]

 STRUCTURE THERAPEUTICS INC.Condensed Consolidated Statements of Operations(unaudited)(In thousands)         THREE MONTHS ENDED   MARCH 31,     2026
    2025
Operating expenses:        Research and development $66,507  $42,867 General and administrative  22,872   13,444 Total operating expenses  89,379   56,311 Loss from operations  (89,379)  (56,311)Interest and other income, net  13,601   9,576 Loss before provision for income taxes  (75,778)  (46,735)Provision for (benefit from) income taxes  190   98 Net loss $(75,968) $(46,833)                     Research and development $5,101  $2,699 General and administrative  6,538   3,219 Total share-based compensation $11,639  $5,918         STRUCTURE THERAPEUTICS INC.Condensed Consolidated Balance Sheet Data(unaudited)(In thousands)          MARCH 31,   DECEMBER 31,      2026   2025   Assets       Current assets:         Cash, cash equivalents and short-term investments $1,458,504 $1,446,197 Prepaid expenses and other current assets  32,094  124,106 Total current assets  1,490,598  1,570,303 Property and equipment, net  6,365  6,653 Operating right-of-use assets  5,606  6,245 Other non-current assets  5,555  717 Total assets $1,508,124 $1,583,918 Liabilities and shareholders’ equity         Current liabilities:         Accounts payable $7,822 $13,864 Accrued expenses and other current liabilities  46,553  46,543 Operating lease liabilities, current portion  2,609  2,878 Total current liabilities  56,984  63,285 Operating lease liabilities, net of current portion  3,183  3,609 Other non-current liabilities  863  647 Total liabilities  61,030  67,541 Total shareholders’ equity  1,447,094  1,516,377 Total liabilities and shareholders’ equity $1,508,124 $1,583,918         

Key Takeaways Lilly is advancing oral obesity pills and next-gen GLP-1 drugs to stay ahead in weight loss.LLY's retatrutide showed strong weight loss and osteoarthritis pain relief in phase III studies.Lilly is testing eloralintide and bimagrumab to expand beyond traditional GLP-1 therapies. Eli Lilly and Company (LLY - Free Report) is a leader in the fast-growing diabetes and obesity market, driven by its blockbuster tirzepatide-based drugs, Mounjaro and Zepbound. Tirzepatide, a dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA), remains the foundation of Lilly’s obesity franchise. Beyond obesity and diabetes, Lilly is evaluating tirzepatide in several obesity-related conditions, such as obstructive sleep apnea (OSA), chronic kidney disease, fatty liver disease and cardiovascular conditions.

Mounjaro and Zepbound face strong competition from Novo Nordisk’s (NVO - Free Report) semaglutide medicines, Ozempic, for diabetes and Wegovy for obesity.

Though Lilly and Novo Nordisk presently dominate the market, they are making rapid progress in the development of more potent and convenient GLP-1 as well as non-GLP-1 based candidates in their clinical pipeline to beat future competition. The global obesity drug market is projected to grow dramatically, reaching nearly $95 billion by 2030 and potentially $125 billion by 2035, according to Goldman Sachs estimates, which means competition is inevitable.

Oral Obesity Drugs Could Be a Commercial Game-ChangerBoth Lilly and NVO have launched oral GLP-1 pills. Lilly’s Foundayo and Novo Nordisk’s Wegovy pill can prove to be commercial game-changers for the respective companies. Oral pills will be a more convenient alternative to the currently available once-weekly injectable obesity treatments like Zepbound and Wegovy. Oral pills may significantly lower the treatment burden and potentially broaden patient adoption versus injections. Oral pills can also be manufactured at scale to meet global demand, which, in turn, can drive billions in additional sales. Both Lilly and Novo Nordisk said their oral pills witnessed strong launches.

Lilly expects to launch Foundayo in most international markets during 2027. For the type II diabetes indication, Lilly has filed regulatory applications for Foundayoin several countries, while it expects to file the same in the United States in late second quarter. In addition to obesity and diabetes, Lilly is evaluating Foundayo in six phase III studies for other diabetes and obesity-related diseases.

Retatrutide May Succeed Tirzepatide in Lilly’s PortfolioLilly is developing several next-generation, more powerful and more convenient GLP-1–based treatments, including oral options and multi-acting candidates. Its obesity and diabetes pipeline has therefore evolved from a traditional insulin and diabetes-drug portfolio into a comprehensive metabolic-disease platform.

A key candidate in its obesity pipeline is triple-acting incretin, retatrutide, being studied in type II diabetes and obesity, along with other indications like OSA, knee osteoarthritis, and chronic low back pain, in late-stage studies. Retatrutide represents a new generation of “triple-action” therapy as it targets three biological pathways — GLP-1, GIP and glucagon — whereas existing medicines mostly act on one or two biological pathways.

Data from a phase III study of retatrutide in obesity and knee osteoarthritis pain showed that the drug led to significant weight loss and substantial relief of osteoarthritis pain. Data from a phase III study in type II diabetes showed that retatrutide can achieve glycemic control comparable to tirzepatide, while providing additional weight loss.

Eloralintide and Bimagrumab Expand Lilly Beyond GLP-1 TherapiesAnother key candidate in Lilly’s diabetes/obesity pipeline is eloralintide, a selective amylin receptor agonist. Lilly is exploring eloralintide both alone and in combination with incretin therapies. Phase III studies are ongoing for obesity, OA knee pain and OSA. Lilly believes that eloralintide has the potential to be a great medicine for patients seeking a non-GLP-1-based mechanism due to tolerability issues.

Through its 2023 acquisition of Versanis, Lilly gained bimagrumab, an ActRII inhibitor being studied alone and in combination with tirzepatide to improve body composition by reducing fat while maintaining or increasing lean muscle mass. It is in phase II studies for obesity.

Competition Heating Up in the Obesity SpaceNovo Nordisk’s other novel candidate in its obesity pipeline is CagriSema, a once-weekly injection, which is a combination of cagrilintide (amylin analogue) and semaglutide (GLP-1). NVO has already filed a new drug application with the FDA seeking approval of CagriSema for obesity. Other key candidates are cagrilintide, a long-acting amylin analog in phase III, and amycretin, a single molecule combining GLP-1 + amylin, which is expected to enter phase III in 2026.

Several other companies, like Amgen, Viking Therapeutics (VKTX - Free Report) and Structure Therapeutics (GPCR - Free Report) are also making rapid progress in the development of more potent and convenient candidates in their clinical pipeline.

Viking Therapeutics’ dual GIPR/GLP-1 receptor agonist, VK2735, is being developed both as oral and subcutaneous formulations for the treatment of obesity.  Viking plans to advance oral VK2735 into phase III development for obesity in the fourth quarter of 2026.

Structure Therapeutics’ phase II ACCESS study on its orally GLP-1 RA, aleniglipron, demonstrated significant weight loss across all doses. Structure Therapeutics expects to initiate the late-stage program of aleniglipron in obesity in the second half of 2026.

Amgen is developing MariTide, a GIPR/GLP-1 receptor, as a single dose in a convenient autoinjector device with a monthly and possibly less frequent dosing. This key feature differentiates it from Zepbound and Wegovy, which are weekly injections. Amgen has nine global phase III studies underway with MariTide in obesity, type II diabetes and other obesity-related conditions.

LLY’s Stock Price, Valuation and EstimatesLilly’s stock has declined 7.9% so far this year compared with the industry’s decrease of 4%.

Image Source: Zacks Investment Research

From a valuation standpoint, Lilly’s stock is expensive. Going by the price/earnings ratio, LLY’s shares currently trade at 25.46 forward earnings, much higher than 16.47 for the industry. However, LLY’s stock is trading below its 5-year mean of 34.57.

Image Source: Zacks Investment Research

The Zacks Consensus Estimate for 2026 has risen from $34.69 to $35.43 per share over the past 30 days, while that for 2027 has risen from $42.98 to $44.26 per share over the same timeframe.

Image Source: Zacks Investment Research

LLY’s Zacks RankLilly has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

HighVista Strategies sold 69,092 shares of Structure Therapeutics (GPCR +4.26%) in the first quarter, an estimated $4.73 million trade based on quarterly average pricing, per the May 15, 2026 SEC filing.

What happenedAccording to an SEC filing dated May 15, 2026, HighVista Strategies reduced its holding in Structure Therapeutics by 69,092 shares during the first quarter. The estimated transaction value was $4.73 million, calculated using the average closing price for the quarter. The position’s quarter-end value decreased by $7.45 million, a figure that incorporates both the share sale and market price fluctuations.

What else to knowThis was a sell; post-trade, the Structure Therapeutics stake represents 1.6491% of HighVista’s reportable U.S. equity AUMTop holdings after the filing:NYSEMKT:DBC: $30.61 million (8.5% of AUM)NASDAQ:ABVX: $12.61 million (3.5% of AUM)NASDAQ:PRAX: $8.48 million (2.3% of AUM)NASDAQ:COGT: $7.58 million (2.1% of AUM)NASDAQ:SYRE: $7.38 million (2.0% of AUM)As of May 14, 2026, shares of Structure Therapeutics were priced at $39.84, up about 60% over the past year and well outperforming the S&P 500’s roughly 25% gain in the same period.Company OverviewMetricValuePrice (as of market close 2026-05-14)$39.84Market Capitalization$2.8 billionNet Income (TTM)($141.2 million)One-Year Price Change60%Company SnapshotStructure Therapeutics develops oral therapeutics targeting chronic diseases, with lead candidate GSBR-1290 for type-2 diabetes and obesity, and additional pipeline assets for pulmonary and cardiovascular indications.The company operates a clinical-stage biopharmaceutical business model focused on proprietary research, development, and out-licensing or commercialization of novel small molecule drugs targeting G-protein-coupled receptors (GPCRs).It targets healthcare providers, biopharma partners, and patients with unmet medical needs in metabolic, pulmonary, and cardiovascular disease segments.Structure Therapeutics Inc. is a clinical-stage biotechnology company specializing in the development of innovative oral small molecule therapeutics for chronic diseases with significant unmet need. The company's strategy leverages expertise in GPCR biology to advance a pipeline of differentiated oral therapeutics for chronic diseases. With a focus on metabolic and pulmonary indications, Structure Therapeutics seeks to establish a competitive edge through proprietary drug design and a robust clinical development program.

What this transaction means for investorsStructure Therapeutics shares have climbed about 60% over the past year as investors piled into companies developing next-generation GLP-1 therapies, especially oral alternatives to injectable weight-loss drugs. With that kind of run, it doesn’t seem surprising for a fund to consider rebalancing.

For its part, the company has continued delivering strong clinical updates. Earlier this month, Structure reported Phase 2 data showing up to 16.3% placebo-adjusted weight loss at 44 weeks for oral obesity candidate aleniglipron, which management said compares favorably with injectable GLP-1 therapies. The company also said it received positive end-of-Phase 2 FDA feedback and remains on track to launch Phase 3 trials in the third quarter.

Separately, Structure ended March with roughly $1.5 billion in cash, cash equivalents, and short-term investments, which management says should fund operations through the end of 2028.

Ultimately, the key question is whether oral GLP-1 drugs can carve out a meaningful slice of a market currently dominated by injectable therapies. High expectations are already baked into many obesity stocks, but Structure’s growing clinical data package suggests the company remains one of the more serious contenders in the space.

Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

Key Takeaways Mounjaro and Zepbound saw strong Q1 sales growth, fueled by robust demand despite lower pricing.New label expansions and indication approvals could further boost Mounjaro and Zepbound sales.Foundayo has reached over 20,000 U.S. patients and a launch is planned for most international markets in 2027. Eli Lilly (LLY - Free Report) has emerged as a dominant force in the cardiometabolic market, driven by strong demand for its blockbuster GLP-1 therapies, Mounjaro for type II diabetes (T2D) and Zepbound for obesity. Both drugs include the same compound, tirzepatide, a dual GIP/GLP-1 RA. The GLP-1 segment is a very important class of drugs for multiple cardiometabolic diseases and is gaining significant popularity.

Despite a short time on the market, Mounjaro and Zepbound have become LLY’s key top-line drivers. Mounjaro is the market leader in new prescriptions among incretin analogs for T2D in both the United States and ex-U.S. markets. At the same time, Zepbound holds a leading market share in the branded obesity market, with nearly 70% of new prescriptions.

In the first quarter of 2026, Mounjaro recorded sales of $8.66 billion, up 125% year over year, while Zepbound’s sales were $4.16 billion, up 80% year over year, driven by increased demand, which offset the impact of lower pricing. The positive trend is expected to continue in 2026.

New indication approvals and ongoing label expansions could further boost sales of Eli Lilly’s Mounjaro and Zepbound. Last year, Zepbound gained FDA approval for obstructive sleep apnea in adults with obesity, while LLY has also filed for a cardiovascular indication based on positive late-stage data. Tirzepatide has also been approved for pediatric and adolescent T2D in the United States and the EU, with additional studies underway in type I diabetes and metabolic dysfunction-associated steatotic liver disease. Lilly is also supporting growth through lower-priced Zepbound vial doses, self-pay savings programs and expanded incretin manufacturing capacity.

Eli Lilly’s newly approved once-daily oral GLP-1 pill, Foundayo, has shown encouraging early launch momentum in obesity, with broad pharmacy availability, access through major telehealth platforms and commercial coverage from two of the three largest U.S. pharmacy benefit managers. More than 8,000 healthcare providers have prescribed the drug, while over 20,000 patients have received it so far, with most prescriptions coming from people new to GLP-1 therapy.

Lilly plans to launch Foundayo in most international markets in 2027 and is pursuing approvals for T2D in several countries, with a U.S. filing expected in late second-quarter 2026. Backed by consistent safety and efficacy data across seven phase III studies, Foundayo is being positioned as a key growth driver for Lilly in obesity, diabetes and related metabolic diseases.

LLY’s Peers in the Obesity SpaceEli Lilly and Novo Nordisk (NVO - Free Report) presently dominate the obesity market. Mounjaro and Zepbound directly compete with NVO’s semaglutide medicines, Ozempic for T2D and Wegovy for obesity. Like Eli Lilly, Novo Nordisk also generates a substantial portion of revenues from both drugs.

Novo Nordisk gained approval for an oral version of its obesity drug, Wegovy, in December 2025 and launched the pill in January 2026, giving it a first-mover advantage over Foundayo. However, Lilly may be able to close the gap quickly now that it has launched Foundayo. Also, Foundayo offers better patient convenience, as it can be taken at any time of day, with or without food. In contrast, NVO’s Wegovy pill must be taken on an empty stomach, followed by a 30-minute wait before eating. However, in terms of side effects, Wegovy has a slight edge, as it appears to have a more stable safety and tolerability profile than Foundayo, whose use is associated with some gastrointestinal side effects.

Smaller biotech firms, like Viking Therapeutics (VKTX - Free Report) and Structure Therapeutics (GPCR - Free Report) , are also advancing GLP-1–based therapies to challenge the incumbents. Viking Therapeutics’ dual GIPR/GLP-1 receptor agonist, VK2735, is being developed both as oral and subcutaneous formulations for the treatment of obesity. Viking Therapeutics plans to advance oral VK2735 into phase III development for obesity in the fourth quarter of 2026.

Structure Therapeutics’ phase II ACCESS study on its orally administered GLP-1 RA, aleniglipron, demonstrated significant weight loss across all doses. Structure Therapeutics expects to initiate the late-stage program of aleniglipron in obesity in the second half of 2026.

LLY’s Stock Price, Valuation and EstimatesShares of Eli Lilly have lost 5.2% year to date compared with the industry’s 0.7% decline. During the same time frame, the company has also underperformed the S&P 500 but outperformed the sector, as seen in the chart below.

LLY Stock Price MovementImage Source: Zacks Investment Research

From a valuation standpoint, LLY stock is expensive. Going by the price/earnings ratio, the company’s shares currently trade at 26.23 forward earnings, higher than 16.98 for the industry. However, the stock is trading below its five-year mean of 34.56.

LLY Stock ValuationImage Source: Zacks Investment Research

Estimates for Eli Lilly’s 2026 earnings have improved from $34.70 to $35.45 per share in the past 30 days, and estimates for 2027 earnings have improved from $42.67 to $44.23 per share over the same time frame.

LLY Estimate MovementImage Source: Zacks Investment Research

Eli Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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Polymarket traders are watching one biotech more closely than any other for an acquisition. Viking Therapeutics (NASDAQ: VKTX | VKTX Price Prediction) carries a 38.5% implied probability of being acquired before 2027, with all-time volume above $1.68 million on that single contract. The hook is obesity. Viking’s VK2735 dual GLP-1/GIP agonist is arguably the most advanced obesity asset not yet owned by Big Pharma. This scenario analysis examines who would actually benefit if a deal happens.

Why Viking Is the Most-Watched M&A Target Viking is a clinical-stage biotech with no revenue and a market cap near $3.59 billion. Shares closed at $30.89 on May 22, 2026, down 12.2% year to date. Analyst sentiment, however, is striking, with almost all analysts rating it Buy or Strong Buy, and a mean target price all the way up at $92.33.

The lead asset is doing the talking. Oral VK2735 delivered up to 12.2% weight loss at 13 weeks, with 80% of participants achieving at least 10% weight loss. Phase 3 VANQUISH-1 is fully enrolled with 4,500+ patients. Cash burn is accelerating: Q4 2025 net loss hit $157.66 million against roughly $706 million in cash, sharpening the strategic clock.

Existing Shareholders Benefit For current holders, the standalone case is the $92.33 analyst target, which assumes successful Phase 3 readouts. A deal would compress that timeline. Biotech buyouts of clinical-stage assets have historically closed well above prevailing prices, and recent obesity deals (notably Pfizer’s roughly $9.8 billion Metsera acquisition) set a reference point. Speculative buyout investing remains one of the highest-risk strategies in biotech: trial setbacks, regulatory delays, and deal breaks can all hit hard.

The Potential Buyer Benefits Eli Lilly (NYSE: LLY) already dominates the category. Q1 2026 revenue of roughly $19.8 billion grew 55.5%, with Mounjaro and Zepbound leading. A second platform still adds optionality, though antitrust optics complicate the fit at its $949.7 billion market cap.

Pfizer (NYSE: PFE) has been the most active acquirer in obesity. CEO Albert Bourla said, “2026 will be an important year rich in key catalysts, including our expectation for approximately 20 key pivotal study starts.” A Phase 3-ready dual agonist would integrate directly into the Metsera pipeline buildout.

Novo Nordisk (NYSE: NVO) is defending share. Shares are down 33.2% over the past year, and 2026 guidance calls for adjusted sales growth of −4% to −12%. A defensive bid is plausible.

Merck and Amgen round out the longer-shot list. Merck is underweight obesity and already acquiring Terns Pharmaceuticals, while Amgen has MariTide advancing internally, which may reduce urgency rather than create it.

Competitors and the Industry Benefit The clearest secondary winner is Structure Therapeutics (NASDAQ: GPCR), whose oral aleniglipron delivered 16.3% placebo-adjusted weight loss at 44 weeks. With a $2.8 billion market cap and a $106.47 average analyst target, Structure would inherit the scarcity premium if Viking is removed from the board. The Terns deal already shows Big Pharma’s willingness to consolidate metabolic assets.

For the broader industry, a Viking transaction would validate the tuck-in playbook, likely re-rate the obesity small-cap basket, and serve as an FTC test case for GLP-1 consolidation. It would also mark Polymarket as a usable M&A signal in biotech research.

The Bottom Line Even with 61.5% odds priced against a deal, Viking remains at the center of the obesity M&A conversation. If a transaction occurs, shareholders, the acquirer, and the broader obesity basket all stand to gain. Worth watching: Phase 3 enrollment updates, oral VK2735 progress, and any Big Pharma business development signaling through the rest of 2026.