Altimmune Outlines Pemvidutide Phase III Plans, Receives Breakthrough Status

Company discusses clinical results, development strategy, and competitive positioning for lead MASH drug candidate at industry conference.

Published on Mar. 10, 2026

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Altimmune executives used a presentation at the Citizens Life Sciences Conference to provide an update on pemvidutide, the company's lead drug candidate being developed primarily for metabolic dysfunction–associated steatohepatitis (MASH). They discussed phase II learnings, the planned phase III trial design, additional liver-related programs, and the company's financial position.

Why it matters

Pemvidutide's potential as a treatment for MASH, a serious liver condition with limited therapeutic options, is an important development in the field of metabolic and liver diseases. Altimmune's plans for the phase III trial and the drug's competitive positioning relative to other MASH therapies will be closely watched by the industry.

The details

Altimmune reported positive trends on non-invasive tests associated with anti-fibrotic activity in the 48-week topline results of its phase II MASH trial, despite not meeting the fibrosis endpoint. For the phase III study, the company plans to evaluate two active doses (1.8 mg and 2.4 mg) and include biopsies to assess fibrosis improvement and MASH resolution at 52 weeks. Altimmune also intends to use an AI-assisted biopsy read process to reduce variability. The company believes pemvidutide's one-to-one glucagon to GLP-1 ratio, which aims to drive rapid liver fat reduction and metabolic benefits, could differentiate it in the MASH market.

  • Altimmune received FDA minutes in early January 2026 confirming alignment on key elements of the phase III design.
  • The company expects to report topline phase II data in alcohol use disorder in the third quarter of 2026.
  • Altimmune anticipates the phase II trial in alcohol-associated liver disease will be fully enrolled this year.

The players

Jerry Durso

Chief Executive Officer of Altimmune.

Linda Richardson

Chief Commercial Officer of Altimmune.

Greg Weaver

Chief Financial Officer of Altimmune.

Altimmune

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

Pemvidutide

Altimmune's lead drug candidate being developed primarily for metabolic dysfunction–associated steatohepatitis (MASH).

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