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Altimmune (Nasdaq: ALT) shows efficacy in Phase 2 pemvidutide AUD trial

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Altimmune reported positive topline Phase 2 results for once-weekly pemvidutide 2.4 mg in patients with moderate to severe alcohol use disorder. The study met its primary endpoint with a highly statistically significant reduction in heavy drinking days per week versus placebo and achieved multiple secondary endpoints, including a two-level reduction in World Health Organization Risk Drinking Levels, zero heavy drinking days and reductions in phosphatidyl ethanol, an objective biomarker of alcohol intake; the first two are recognized by the FDA as registrational endpoints.

Pemvidutide showed a generally favorable safety and tolerability profile, with gastrointestinal adverse events such as nausea, vomiting, diarrhea and constipation more frequent than placebo but mostly mild to moderate in severity, and similar overall treatment discontinuation rates between arms. Altimmune plans to request an End-of-Phase 2 meeting with the FDA, submit the results for scientific presentation and publication, and continue developing pemvidutide across alcohol use disorder and serious liver diseases.

Positive

  • Pemvidutide met the Phase 2 primary endpoint, reducing heavy drinking days per week versus placebo with a least-squares mean difference of -1.45 and p=0.0014, indicating strong statistical evidence of efficacy in alcohol use disorder.
  • Key FDA-recognized secondary endpoints were achieved: a two-level WHO Risk Drinking Level reduction in 64.4% of pemvidutide patients vs 34.8% on placebo and zero heavy drinking days in 42.2% vs 17.4%, with supportive biomarker (PEth) improvements.

Negative

  • None.

Filing Explained

The stated treatment effect was 1.45 fewer heavy-drinking days per week, while drug-related discontinuation occurred in 10% of pemvidutide patients.

On July 28, 2026, Altimmune’s 8-K reported topline results from its Phase 2 alcohol use disorder trial: the primary and key secondary endpoints were met, and the next disclosed regulatory step is a planned request for an FDA End-of-Phase 2 meeting.

The study randomized approximately 100 patients 1:1 to weekly pemvidutide 2.4 mg or placebo for 24 weeks. At Week 24, the reported change in heavy drinking days per week was -4.20 with pemvidutide versus -2.75 with placebo, with a stated treatment effect of -1.45. The two-level reduction in WHO risk drinking level occurred in 64.4% of pemvidutide patients versus 34.8% of placebo patients, while zero heavy drinking days during Weeks 21–24 occurred in 42.2% versus 17.4%.

Gastrointestinal events were more frequent with pemvidutide, including nausea at 44%, vomiting at 18%, diarrhea at 20%, and constipation at 26%; treatment discontinuation was 20% versus 22% with placebo, while study-drug-related discontinuation was reported in 10% of pemvidutide patients.

Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Primary endpoint HDD change -1.45 HDD/week (LS mean difference) Change from baseline in heavy drinking days per week at Week 24; p=0.0014 versus placebo
Two-level WHO-RDL reduction 64.4% vs 34.8% Proportion of patients with two-level WHO Risk Drinking Level reduction; odds ratio 3.31, p=0.0049
Zero heavy drinking days 42.2% vs 17.4% Patients with zero heavy drinking days in Weeks 21–24; odds ratio 3.84, p=0.0066
Percent days abstinent 38.9% vs 20.5% Change from baseline in percent days with abstinence; LS mean difference 18.4%, p=0.0075
Serum PEth change -153.4 vs 22.0 Least-squares mean change in serum phosphatidyl ethanol at Week 24, pemvidutide vs placebo
Nausea incidence 44% vs 24% Proportion of patients with nausea in pemvidutide 2.4 mg vs placebo arms
Drug-related AE discontinuations 10% vs 0% Study drug-related adverse events leading to treatment discontinuation in pemvidutide vs placebo
heavy drinking days (HDD) medical
"reduction in heavy drinking days (HDD) versus placebo, with consistent positive results"
World Health Organization Risk Drinking Levels medical
"including the World Health Organization (WHO) Risk Drinking Levels (RDL), zero HDD"
phosphatidyl ethanol (PEth) medical
"absolute change from baseline in average levels of phosphatidylethanol (PEth), an objective serum biomarker"
End-of-Phase 2 meeting regulatory
"The Company plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration"
An end-of-phase 2 meeting is a formal discussion between a drug developer and a regulatory agency to review mid-stage clinical results and agree on the plan and requirements for the larger, final tests needed for approval. It matters to investors because the meeting can clarify what evidence regulators will require, shape the cost and timeline for the next phase, and reduce uncertainty about whether a drug can advance toward market — like a checkpoint that determines whether a project gets the green light to move to the next, expensive stage.
Fast Track designations regulatory
"The FDA granted Fast Track designations to pemvidutide for the treatment of MASH and AUD"
A fast track designation is a regulatory status granted to a drug or therapy intended to treat a serious condition with unmet medical need, which gives the developer access to expedited interactions and review procedures with regulators. For investors, it’s like an express lane: it can shorten development and review timelines and reduce regulatory uncertainty, potentially speeding a product to market—but it does not guarantee approval or commercial success.
Breakthrough Therapy Designation regulatory
"as well as Breakthrough Therapy Designation for MASH"
A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

What Phase 2 results did Altimmune (ALT) report for pemvidutide in alcohol use disorder?

Altimmune reported that pemvidutide 2.4 mg met the primary endpoint in a Phase 2 alcohol use disorder trial, showing a -1.45 least-squares mean reduction in weekly heavy drinking days versus placebo and statistically significant benefits across several drinking and biomarker secondary endpoints.

How did pemvidutide perform on FDA-recognized secondary endpoints in the Altimmune (ALT) trial?

Pemvidutide achieved a two-level WHO Risk Drinking Level reduction in 64.4% of patients versus 34.8% on placebo and produced zero heavy drinking days in 42.2% vs 17.4%, endpoints the FDA recognizes as registrational for alcohol use disorder treatments.

What were the key safety findings for pemvidutide in Altimmune (ALT)’s AUD Phase 2 study?

Pemvidutide showed a generally favorable tolerability profile, with higher rates of gastrointestinal adverse events such as nausea (44% vs 24% placebo) and constipation (26% vs 6%) but similar overall discontinuations (20% vs 22%) and few serious events.

What biomarker changes did Altimmune (ALT) observe with pemvidutide in the AUD trial?

Pemvidutide led to a substantial decrease in serum phosphatidyl ethanol (PEth), with a least-squares mean change of -153.4 versus 22.0 on placebo, supporting the self-reported reductions in alcohol consumption seen in the trial.

What are Altimmune (ALT)’s next regulatory steps for pemvidutide in alcohol use disorder?

Based on the Phase 2 results, Altimmune plans to request an End-of-Phase 2 meeting with the FDA to discuss the development path for pemvidutide in alcohol use disorder and intends to present and publish the data at scientific venues.

How was the Altimmune (ALT) pemvidutide Phase 2 AUD trial designed?

The trial randomized about 100 patients with alcohol use disorder and BMI >25 kg/m2 1:1 to once-weekly pemvidutide 2.4 mg or placebo for 24 weeks, measuring change in average heavy drinking days per week as the primary endpoint.
0001326190false00013261902026-07-282026-07-28

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 28, 2026

ALTIMMUNE, INC.

(Exact name of registrant as specified in its charter)

Delaware

 

001-32587

 

20-2726770

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

910 Clopper Road, Suite 201S

Gaithersburg, Maryland

20878

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number including area code: (240) 654-1450

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common stock, par value $0.0001 per share

ALT

The NASDAQ Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Item 7.01 Regulation FD Disclosure.

On July 28, 2026, Altimmune, Inc. (the “Company”) issued a press release (the “Press Release”) announcing the positive topline results from the RECLAIM Phase 2 trial evaluating pemvidutide 2.4 mg dose, an investigational balanced glucagon/GLP-1 dual receptor agonist, in patients with moderate to severe alcohol use disorder (AUD).

The information in this Item 7.01, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01 Other Events.

As noted above, on July 28, 2026, the Company announced the positive topline results from the RECLAIM Phase 2 trial evaluating the 2.4 mg dose of pemvidutide, an investigational balanced glucagon/GLP-1 dual receptor agonist, in patients with moderate to severe AUD.

The trial met its primary endpoint with a highly statistically significant reduction in heavy drinking days per week (HDD) versus placebo, with positive results across important secondary endpoints, including a two-level reduction in the World Health Organization Risk Drinking Level and zero HDDs, both of which are U.S. Food and Drug Administration (FDA) registrational endpoints, as well as a reduction in phosphatidyl ethanol levels. A generally favorable safety and tolerability profile was observed in the trial. The Company plans to request an End-of-Phase 2 meeting with the FDA based on the results of the trial.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

No.

  ​

Description

99.1

Press Release of Altimmune, Inc. dated July 28, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

ALTIMMUNE, INC.

By:

 

/s/ Gregory Weaver

 

Name: Gregory Weaver

 

Title: Chief Financial Officer

Dated: July 28, 2026

Exhibit 99.1

Altimmune Announces Positive Topline Results from RECLAIM Phase 2 Trial of Pemvidutide in Alcohol Use Disorder

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 – 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

Endpoint

Placebo

Pemvidutide

Treatment Effect

P-value

Change from baseline in HDD/Week at Week 24 (Primary Endpoint)

-2.75 (LS mean)

-4.20 (LS mean)

-1.45 (LS mean difference)

0.0014

2-level Reduction in WHO-RDL

34.8% (16/46)

64.4% (29/45)

Odds Ratio 3.31

0.0049

Zero HDD in Week 21 through Week 24

17.4% (8/46)

42.2% (19/45)

Odds Ratio 3.84

0.0066

Change from baseline in Percent of Days with Abstinence

20.5% (LS mean)

38.9% (LS mean)

18.4% (LS mean difference)

0.0075

Change from baseline in Serum PEth at Week 24

22.0 (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 AEs

1 (2%)

2 (4%)

Severe AEs

3 (6%)

6 (12%)

Nausea

12 (24%)

22 (44%)

Vomiting

3 (6%)

9 (18%)

Diarrhea

5 (10%)

10 (20%)

Constipation

3 (6%)

13 (26%)

Treatment discontinuations

11 (22%)

10 (20%)

Study drug-related AEs leading to treatment discontinuation

0 (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

ir@altimmune.com

Media Contact:
Real Chemistry 
altimmune@realchemistry.com


Filing Exhibits & Attachments

4 documents