Altimmune Stock Price, News & Analysis

Altimmune (NASDAQ:ALT) announced positive results from its IMPACT Phase 2b trial for pemvidutide in MASH treatment. The drug achieved statistically significant MASH resolution in up to 59.1% of patients and demonstrated fibrosis improvement in up to 34.5% of treated patients. New data showed potentially class-leading improvements in corrected T1 (cT1) imaging, with significant decreases of 145.0ms and 147.9ms in the 1.2mg and 1.8mg groups respectively.

The company reported $183.1 million in cash and investments as of June 30, 2025, a 39% increase from December 31, 2024. Altimmune initiated two new Phase 2 trials: RECLAIM for Alcohol Use Disorder and RESTORE for Alcohol-Associated Liver Disease. An End-of-Phase 2 Meeting with FDA is expected in Q4 2025, with full 48-week IMPACT trial data also anticipated in the same quarter.

Altimmune (NASDAQ:ALT) has appointed Jerry Durso as Chairman of the Board of Directors, effective August 12, 2025. The appointment comes as the company prepares for Phase 3 development of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH). Durso, who joined the Board in February 2025, succeeds Mitchel Sayare, Ph.D., who will continue serving as an Independent Director.

The leadership transition aligns with Altimmune's planned advancement of pemvidutide, with an End-of-Phase 2 Meeting with the FDA scheduled for Q4 2025. Durso brings over 30 years of life sciences industry experience, most recently serving as CEO of Intercept Pharmaceuticals, where he led the company's successful rare liver disease franchise and its acquisition by Alfasigma.

Altimmune (NASDAQ:ALT), a late clinical-stage biopharmaceutical company, has scheduled its second quarter 2025 financial results announcement for Tuesday, August 12, 2025. The company will host a conference call at 8:30 am ET featuring management discussion of financial results and a business update.

The conference call will be accessible via webcast on Altimmune's Investor Relations website, with dial-in registration available for participants. A replay will be available on the website for up to three months following the call.

Altimmune (NASDAQ:ALT) has initiated the RESTORE Phase 2 trial evaluating pemvidutide for Alcohol-Associated Liver Disease (ALD). The randomized, placebo-controlled study will enroll 100 patients across 34 sites, with patients receiving either 2.4mg pemvidutide or placebo for 48 weeks.

The trial's primary endpoint focuses on changes in liver stiffness measurement at Week 24, with secondary endpoints including measurements at Week 48, Enhanced Liver Fibrosis score changes, and alterations in alcohol consumption and body weight. The study follows FDA clearance of the IND application in January 2025.

Pemvidutide, a novel GLP-1/glucagon dual receptor agonist, targets a significant medical need, as over 6 million Americans with Alcohol Use Disorder have progressed to ALD, a condition currently lacking approved treatments.

Altimmune (NASDAQ:ALT) announced positive topline results from its IMPACT Phase 2b trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH). The trial, involving 212 participants, demonstrated significant efficacy with up to 59.1% achieving MASH resolution without worsening of fibrosis at 24 weeks. The study showed weight loss of up to 6.2% with no plateauing and liver fat reductions of up to 62.8%.

The drug exhibited exceptional tolerability with less than 1% treatment discontinuations due to adverse events in pemvidutide-treated participants. The 1.2mg and 1.8mg doses demonstrated statistically significant improvements across multiple endpoints compared to placebo, including non-invasive tests of fibrosis. A supplemental AI-based analysis showed 30.6% of participants receiving pemvidutide 1.8mg achieved a 60% or greater reduction in fibrosis.

Altimmune (NASDAQ:ALT) has announced it will host an investor webcast on June 26, 2025, at 8:30 AM ET to present topline 24-week results from its IMPACT Phase 2b trial of pemvidutide in treating metabolic dysfunction-associated steatohepatitis (MASH). The conference call will feature remarks from Altimmune management and Dr. Mazen Noureddin, Professor of Medicine at Houston Methodist Hospital and Co-Chairman of the Board for Summit Clinical Research and Pinnacle Clinical Research.

The webcast will be available for replay on the company's Investor Relations website following the presentation. Participants can access the call by registering online to receive dial-in information.

Altimmune (NASDAQ: ALT) announced four presentations on pemvidutide, their investigational GLP-1/glucagon dual receptor agonist, at the upcoming American Diabetes Association's 85th Scientific Sessions in Chicago. The presentations include one oral presentation focusing on pemvidutide's effects on cardioinflammatory lipids in subjects with obesity, and three poster presentations covering cardiovascular safety, central adiposity measurements, and cholesterol transport studies. Pemvidutide is being developed for multiple indications including MASH, obesity, alcohol use disorder, and alcohol-associated liver disease. The presentations will take place between June 20-23, 2025, featuring research from Altimmune's senior directors Dr. John J. Suschak and Dr. Shaheen Tomah.

Altimmune (NASDAQ: ALT) has initiated the RECLAIM Phase 2 trial for pemvidutide in Alcohol Use Disorder (AUD). The trial will evaluate the drug's efficacy and safety across approximately 15 U.S. sites, enrolling about 100 subjects in a 1:1 randomization to receive either 2.4 mg pemvidutide or placebo weekly for 24 weeks.

The trial's primary endpoint focuses on changes in alcohol consumption, measured by heavy drinking days per week at Week 24. Pemvidutide, a novel GLP-1/glucagon dual receptor agonist, is also being studied for MASH, obesity, and alcohol liver disease (ALD). The company expects topline data from the IMPACT Phase 2b trial in MASH in Q2 2025 and plans to initiate a Phase 2 trial in ALD in Q3 2025.

The study addresses a significant market opportunity, with over 28 million individuals in the U.S. affected by AUD, where less than 10% receive treatment and 2% or less use approved medications.

Altimmune (Nasdaq: ALT), a late clinical-stage biopharmaceutical company focused on liver and cardiometabolic diseases, has announced its participation in two upcoming investor conferences. Management will attend the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, with a fireside chat at 10:00 AM ET, and the Jefferies Global Healthcare Conference on June 4, 2025, with a fireside chat at 9:55 AM ET. Both events will take place in New York, and webcasts will be available on Altimmune's website. The company will also be available for one-on-one meetings during these conferences.