Altimmune Details Pemvidutide MASH Path: Breakthrough Therapy, FDA Feedback, Phase 3 Next Up

Executives outline plans to advance pemvidutide into Phase 3 for metabolic dysfunction-associated steatohepatitis (MASH)

Published on Mar. 11, 2026

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Altimmune (NASDAQ:ALT) executives highlighted recent clinical and regulatory milestones for pemvidutide and outlined plans to advance a Phase 3 program in metabolic dysfunction-associated steatohepatitis (MASH) during a presentation at the Leerink Partners Global Healthcare Conference. The company received Breakthrough Therapy designation from the FDA and obtained alignment on key elements of the Phase 3 design after positive 24-week and 48-week data from its Phase 2 IMPACT study.

Why it matters

Pemvidutide's dual agonist mechanism targeting both glucagon and GLP-1 receptors is intended to address the complex pathophysiology of MASH, a serious liver disease with limited treatment options. The company's approach to tolerability and use of non-invasive tests in the Phase 3 program could help differentiate pemvidutide in the competitive MASH landscape.

The details

Altimmune plans to evaluate the 1.8 mg and 2.4 mg doses of pemvidutide in the Phase 3 program, which will include a 52-week histology endpoint to demonstrate improvements in fibrosis. The company will also incorporate the FDA-cleared AIM-MASH Assist tool from PathAI to help reduce variability in histology assessments. Additionally, Altimmune is pursuing global regulatory alignment and has two other Phase 2 trials ongoing in alcohol-related indications.

  • The company held an end-of-Phase 2 meeting with the FDA and received a Breakthrough Therapy designation in 2025.
  • Altimmune presented 24-week data from the Phase 2 IMPACT study in mid-2025 and 48-week data in December 2025.

The players

Altimmune

A clinical-stage biopharmaceutical company headquartered in Gaithersburg, Maryland, dedicated to the development of vaccines and immunotherapeutics.

Jerry Durso

Chief Executive Officer of Altimmune.

Christophe Arbet-Engels

Chief Medical Officer of Altimmune.

PathAI

A company that developed the FDA-cleared AIM-MASH Assist tool for histology evaluation, which Altimmune plans to use in its Phase 3 MASH trial.

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