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Key Takeaways Altimmune has launched the global PERFORMA Phase III study to test pemvidutide in MASH.Phase IIb data showed MASH resolution and signs of reduced liver scarring through 48 weeks.Altimmune expects its cash runway to support operations into 2029 and has secured Phase III capacity. Altimmune (ALT - Free Report) has moved pemvidutide into phase III development for metabolic dysfunction-associated steatohepatitis (MASH), shifting the program from mid-stage evidence to a pivotal global test.

The transition puts more weight on execution. Investors must now judge whether earlier efficacy signals, regulatory support and operational preparation can carry the program through a multi-year development window.

Altimmune Moves Pemvidutide Into Phase IIIThe global PERFORMA study is evaluating pemvidutide in adults with MASH and moderate-to-severe liver fibrosis. The randomized, placebo-controlled trial will assess MASH resolution, fibrosis improvement and liver-related outcomes.

PERFORMA includes two cohorts and an interim analysis intended to support a potential accelerated-approval pathway. Altimmune expects 52-week data in 2029, while final approval would depend on liver-related events at about 60 months.

ALT Enters Phase III With Supportive MASH DataPhase IIb testing showed statistically significant MASH resolution without worsening fibrosis at 24 weeks. That effect was sustained through 48 weeks.

Pemvidutide also showed signs of reducing liver scarring by week 48. Markers of liver damage and inflammation continued improving over time, alongside weight loss.

Altimmune's Dual-Agonist Profile Drives the ThesisPemvidutide combines balanced 1:1 glucagon and GLP-1 receptor activity. Glucagon acts directly on the liver, while GLP-1 supports weight loss through appetite reduction and may provide anti-inflammatory benefits.

Altimmune also uses its EuPort technology to slow absorption. The company believes this may improve tolerability and reduce gastrointestinal side effects, which could help patients remain on long-term treatment.

ALT's Regulatory Status Could Support DevelopmentThe FDA has granted pemvidutide Breakthrough Therapy Designation for MASH. The candidate also has Fast Track designation for the same indication.

Those designations sit alongside PERFORMA's interim-analysis framework as Altimmune pursues a registrational pathway. The pivotal study remains the central test of whether the phase IIb profile can translate into late-stage results.

Altimmune Has Cash and Manufacturing in PlaceAltimmune ended June 2026 with $519 million in cash, cash equivalents and short-term investments, up from $332 million at the end of March. Management expects the cash runway to support operations into 2029.

The company has also secured manufacturing capacity for the global phase III MASH study, with room to scale further if needed. That preparation reduces near-term supply and program-execution concerns.

ALT's 2029 Readout Leaves a Long Execution WindowPERFORMA enrollment is expected to take 18 to 24 months, with management targeting the lower end. Any slippage could extend the pivotal timeline before investors receive the key clinical readout.

Competition is another constraint. The field spans GLP-1 drugs, dual and triple agonists, FGF21 therapies and other mechanisms. Novo Nordisk (NVO - Free Report) has advanced semaglutide through phase III MASH testing. Eli Lilly and Company (LLY - Free Report) is testing tirzepatide and retatrutide in a phase III liver-outcomes program for high-risk metabolic dysfunction-associated steatotic liver disease.

ALT's Momentum Score Adds Support but Not ConvictionThe phase III launch is an important clinical milestone, but Altimmune still faces a long path to the 2029 data. Successful enrollment, trial execution and differentiation in a crowded market will determine how much value investors ultimately assign to pemvidutide.

ALT currently carries a Zacks Rank #3 (Hold) and a Momentum Score of A. Its Value Score of F, Growth Score of F and VGM Score of F show a much weaker profile across the other Zacks Style Score dimensions. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

The A Momentum Score signals comparatively favorable momentum characteristics, but Style Scores are designed to complement the Zacks Rank. With a #3 Rank and F grades in Value, Growth and VGM, ALT's current indicators remain mixed rather than broadly supportive.

MarketBeat Week in Review – 11/4 - 11/8Altimmune NASDAQ: ALT said it has initiated patient enrollment in its global Phase III PERFORMA trial of pemvidutide for metabolic dysfunction-associated steatohepatitis, or MASH, while advancing plans for later-stage development in alcohol use disorder, or AUD.

Chairman and Chief Executive Officer Jerome Durso said 2026 has marked significant progress as the company focuses on serious liver diseases. The company began enrolling patients in PERFORMA about three months after securing funding intended to support the program through its 52-week data readout.

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Phase III MASH Program Underway How Altimmune Could Grab a Big Chunk of the GLP-1 MarketChief Medical Officer Dr. Christophe Arbet-Engels said PERFORMA will be conducted at roughly 300 sites, with approximately one-third in the U.S. and two-thirds outside the U.S. Altimmune is targeting enrollment at the lower end of an estimated 18- to 24-month range for studies of this type.

The company said it has sought to reduce screening failures and pathology variability through the trial design, including use of AIM-MASH AI-assisted pathology. Under the process described on the call, digitized biopsy slides will be assessed by the AI system, which will identify features and propose scores for pathologists to review. Pathologists will remain responsible for final scoring under a consensus-reading process.

This Small Cap Wealth Management Stock Could Provide Big ReturnsAltimmune said patients using GLP-1 therapies at antidiabetic doses may be included in PERFORMA. However, patients using Rezdiffra will not be included because the company does not want to compromise the trial’s 52-week biopsy endpoint. The company also plans to characterize patients who previously did not respond to or could not tolerate GLP-1 therapies or Rezdiffra.

The company expects the PERFORMA 52-week data readout in 2029.

AUD Data Supports Regulatory Planning Altimmune in July reported positive topline results from the Phase II RECLAIM trial in AUD. Arbet-Engels said the 2.4-milligram dose of pemvidutide met the primary endpoint by reducing heavy drinking days by 1.45 per week versus placebo at week 24.

The trial also met secondary endpoints that the company said are recognized by the FDA as potential registrational measures. Roughly two-thirds of pemvidutide-treated patients achieved a two-level reduction in World Health Organization risk drinking levels, compared with about one-third of placebo patients. More than twice as many pemvidutide patients achieved zero heavy drinking days versus placebo, according to the company.

Altimmune also reported statistically significant changes in abstinent drinking days, phosphatidylethanol, or PEth, levels, and body weight. The company said pemvidutide patients had a 9.1% reduction in body weight from baseline versus placebo.

In an exploratory analysis among patients with a baseline FIB-4 score above 1.3, Altimmune said 50% of pemvidutide-treated patients moved below that threshold after 24 weeks, compared with 17% of placebo patients. FIB-4 is a biomarker associated with risk of liver fibrosis.

The company plans to prepare a data package for an end-of-Phase-II meeting with the FDA and also expects to engage European regulators. Arbet-Engels said the company currently expects one global pivotal AUD trial could be sufficient, subject to regulatory discussions.

A potential Phase III AUD program would focus on moderate-to-severe AUD, could include patients with a body mass index below 25, and may evaluate lower-dose options. Altimmune said it would likely use a 24-week primary efficacy endpoint while following patients through 52 weeks for further analyses and safety data. The company has not provided guidance on trial timing.

ALD Enrollment Completed Altimmune said it completed enrollment in the Phase II RESTORE trial in alcohol-associated liver disease, or ALD. The study enrolled about 120 patients with ALD and a history of chronic heavy drinking, and topline data are expected in the second half of 2027.

The company amended the RESTORE protocol so that liver stiffness measurements will be assessed hierarchically at week 48 and then at week 24. Altimmune said the change is intended to better characterize potential liver benefits over one year and support future regulatory discussions.

Management said the protocol change did not alter the study’s population or power assumptions. The company also said a separate hepatic-impairment study enabled it to broaden RESTORE eligibility for patients with higher liver stiffness measurements, after observing no added risk in that population.

Second-Quarter Financial Results and Runway Altimmune reported a second-quarter net loss of $22.8 million, or $0.12 per share, compared with a net loss of $22.1 million, or $0.27 per share, in the prior-year quarter.

Research and development expense was $18.7 million, up from $17.2 million a year earlier. General and administrative expense was $7.6 million, compared with $5.7 million in the prior-year period. R&D spending included $11.6 million in direct pemvidutide-development costs, including $3.8 million for MASH, $5.3 million for Phase II AUD and ALD trials, and $2.5 million for chemistry, manufacturing and controls activities. Chief Financial Officer Greg Weaver said Altimmune raised approximately $310 million year to date, including a $225 million follow-on offering in April. The company had $519 million in cash as of June 30.

Weaver said the cash balance is expected to fund operations through the PERFORMA Phase III MASH 52-week readout in 2029, but does not include funding for a potential Phase III AUD trial. The company said its preference is to use non-dilutive financing for that program, potentially including royalties, debt or strategic partnerships.

About Altimmune (NASDAQ:ALT)Altimmune, 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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Pemvidutide 2.4 mg delivered a statistically significant and clinically meaningful reduction in heavy drinking days, the primary endpoint of the trial 

Important secondary endpoints were also met, including two-level reduction in WHO risk drinking levels and zero heavy drinking days, both of which are recognized by the FDA as registrational endpoints

A generally favorable tolerability profile was observed in the trial

Conference call to be held today at 8:00 am ET

GAITHERSBURG, Md., July 28, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company focused on serious liver diseases, today announced positive topline results from the RECLAIM Phase 2 trial evaluating pemvidutide, an investigational balanced glucagon/GLP-1 dual receptor agonist, in patients with moderate to severe alcohol use disorder (AUD). The trial met its primary endpoint with a highly statistically significant reduction in heavy drinking days (HDD) versus placebo, with consistent positive results across important secondary endpoints, including the World Health Organization (WHO) Risk Drinking Levels (RDL), zero HDD and phosphatidyl ethanol (PEth) levels.  A generally favorable tolerability profile was observed in the trial. The Company plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) based on the results of the trial.

“We are extremely encouraged by these compelling topline results, which showed a highly significant reduction in heavy drinking days and nearly two-thirds of patients treated with pemvidutide achieving a two-level reduction in their WHO-RDL, a clinically meaningful outcome for these patients,” said Christophe Arbet-Engels, M.D., Ph.D., Chief Medical Officer at Altimmune. “These data reflect pemvidutide’s strong and consistent efficacy across important measures of drinking behavior, together with a generally favorable tolerability profile in this difficult-to-treat disorder. Given the known detrimental effects of alcohol on the liver, the liver-directed impact of glucagon in pemvidutide may provide further benefit in the treatment of AUD over GLP-1 alone, underscoring pemvidutide’s promising potential differentiation.”

Efficacy Data

EndpointPlaceboPemvidutideTreatment EffectP-valueChange from baseline in HDD/Week at Week 24 (Primary Endpoint)-2.75 (LS mean)-4.20 (LS mean)-1.45 (LS mean difference)0.00142-level Reduction in WHO-RDL34.8% (16/46)64.4% (29/45)Odds Ratio 3.310.0049Zero HDD in Week 21 through Week 2417.4% (8/46)42.2% (19/45)Odds Ratio 3.840.0066Change from baseline in Percent of Days with Abstinence20.5% (LS mean)38.9% (LS mean)18.4% (LS mean difference)0.0075Change from baseline in Serum PEth at Week 2422.0 (LS mean)-153.4 (LS mean) -175.3 (LS mean difference)<0.0001      Key efficacy results included:

Statistically significant reduction in the primary endpoint of HDD per week versus placebo (p=0.0014)Statistically significant results on secondary endpoints, including two that are registrational endpoints Two-level reduction in WHO Risk Drinking Levels versus placebo (p=0.0049)Zero heavy drinking days versus placebo (p=0.0066) Statistically significant change in percent of days with abstinence versus placebo (p=0.0075)Statistically significant reduction in PEth levels versus placebo (p<0.0001)Statistically significant reduction in body weight, as measured by a placebo-adjusted difference in change from baseline of 9.1% at 24 weeks (p<0.0001), with no evidence of plateauing Safety and Tolerability Data

Adverse Event (AE)Placebo
(N=50)Pemvidutide 2.4mg
(N=50)Serious AEs1 (2%)2 (4%)Severe AEs3 (6%)6 (12%)Nausea12 (24%)22 (44%)Vomiting3 (6%)9 (18%)Diarrhea5 (10%)10 (20%)Constipation3 (6%)13 (26%)Treatment discontinuations11 (22%)10 (20%)Study drug-related AEs leading to treatment discontinuation0 (0%)5 (10%)*    *2 vomiting, 1 constipation, 1 fatigue, 1 exacerbation of hemorrhoids

Pemvidutide was generally well tolerated in this patient population with high unmet need.
The new, simple two-step titration for the 2.4 mg dose may improve gastrointestinal (GI) tolerability compared to prior pemvidutide titration schemes. The majority of adverse events were mild to moderate in severity. There was one serious adverse event (SAE) (hyponatremia) in the pemvidutide arm that was deemed possibly related to treatment drug by the principal investigator.

“As someone who has dedicated his career to understanding and treating alcohol use disorder, I recognize the significance of these findings, particularly given the current attention on the adverse health impact of heavy drinking. These results provide a consistent picture of treatment benefit on self-reported drinking outcomes, supported by objective PEth biomarker evidence,” said Henry Kranzler, M.D., Karl E. Rickels Professor of Psychiatry and Director, Center for Studies of Addiction, University of Pennsylvania Perelman School of Medicine, and Principal Investigator of the RECLAIM trial. “These data underscore the potential for pemvidutide to address multiple dimensions of alcohol use disorder by supporting abstinence and reducing heavy drinking, findings that build on prior evidence of its activity in the liver.”

“These top-line data strengthen our confidence in pemvidutide's differentiation and its potential to benefit people living with MASH, AUD and ALD, who currently have limited treatment options,” said Jerry Durso, Chief Executive Officer and Chairman of the Board of Altimmune. “These results represent yet another important milestone for Altimmune as we continue to execute on our goal to bring pemvidutide to patients with serious liver diseases while creating value for shareholders.”

Based on these data, Altimmune plans to request an End-of-Phase 2 (EOP2) meeting with the FDA to discuss the path forward for pemvidutide in AUD. Results from the RECLAIM trial will be submitted for presentation at a forthcoming medical conference and for publication in a peer-reviewed journal.

Conference Call Information
Altimmune will host a conference call and webcast at 8:00 a.m ET today to discuss the RECLAIM topline data. The conference call will be webcast live on Altimmune’s Investor Relations (IR)  website. Participants who would like to join by phone may register here to receive the dial-in numbers and unique pin to access the call. Following the conclusion of the call, the webcast will be available for replay on the IR page of the company’s website.

About RECLAIM

RECLAIM (NCT06987513) is a Phase 2 trial evaluating the safety and efficacy of pemvidutide in Alcohol Use Disorder (AUD) patients with BMI >25 kg/m2, and is the first Phase 2 multicenter study evaluating a dual glucagon-GLP-1 agonist in AUD to report results. Approximately 100 patients were randomized 1:1 to receive either 2.4 mg pemvidutide or placebo once weekly for 24 weeks. The primary endpoint of the trial was the change from baseline in the average number of heavy drinking days (HDD) per week, with secondary endpoints including the proportion of patients achieving a 2-level reduction in World Health Organization (WHO) Risk Drinking Levels (RDL), zero HDD, and absolute change from baseline in average levels of phosphatidylethanol (PEth), an objective serum biomarker of alcohol intake. The 2-level reduction in WHO risk drinking levels and zero HDD are recognized by the FDA as registrational endpoints.

About AUD

Alcohol use disorder (AUD) is a medical condition driven by an impaired ability to stop or control the harmful consumption of alcohol. AUD can also lead to serious health consequences, including liver cirrhosis, cardiovascular disease, and cancer. Additionally, many patients with AUD present with comorbidities including excess fat in the liver and obesity, further amplifying their risk for poor outcomes. The World Health Organization estimates that harmful alcohol consumption is the seventh leading cause of global death and disability, with alcohol accounting for 50% of all liver-related deaths.

Today, it is estimated that 28 million adults in the U.S. suffer from AUD. Patients with AUD are characterized as mild, moderate or severe according to the DSM-5 criteria with approximately 12 million having moderate or severe forms of the disease. Only three drugs for AUD have been approved by the FDA, but these agents have limited efficacy for AUD and its comorbidities and are used by less than 2% of patients. There is a substantial unmet need for new and more effective treatments that not only reduce alcohol cravings and heavy drinking days but also can address the numerous other risks of the disease.

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, and may play a role in pathways related to craving and reward.

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. In July 2026, the Company announced results from the RECLAIM Phase 2 trial in AUD. The RESTORE trial in ALD was initiated in July 2025, and enrollment completion is expected in the third quarter 2026. The Company plans to initiate the PERFORMA Phase 3 trial, a multinational, randomized, double-blind, placebo-controlled, parallel-group study of pemvidutide in patients with MASH in the third quarter of 2026.

About Altimmune

Altimmune is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company’s lead candidate, pemvidutide, is a unique dual-action therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of MASH, AUD and ALD. For more information, please visit www.altimmune.com.

Forward-Looking Statements

This press release has been prepared by Altimmune, Inc. ("we," "us," "our," "Altimmune" or the "Company") and includes certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, the performance of our drug candidates in ongoing and future clinical trials including the RECLAIM trial (topline results of which are described herein), the ongoing RESTORE trial and the planned PERFORMA trial, evaluating pemvidutide in patients with MASH, AUD and ALD, the potential benefits of Fast Track and Breakthrough Therapy Designations and the prospects for regulatory approval, commercializing, market size, market potential, competitive landscape, or selling any product or drug candidates. In addition, when or if used in this presentation, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict,” “potential”, “suggest” and similar expressions and their variants, as they relate to the Company 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 such as 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; patient baseline characteristics which may vary and impact the success of future trials; 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; whether the FDA will agree with the Company's proposed development and regulatory strategy for pemvidutide in AUD, including following any End-of-Phase 2 meeting; the risk that results from the RECLAIM trial may not be predictive of results in the RESTORE trial, the planned PERFORMA trial, or any other future or larger clinical trial; the Company's need for substantial additional capital to complete development of pemvidutide, which may not be available on acceptable terms or at all; competition from other companies developing treatments for MASH, AUD and ALD; and the success of future product advancements, including the success of current and 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 latest annual report on Form 10-K, quarterly report on Form 10-Q and our 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 
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