Altimmune Inc. (ALT) announced that the U.S. FDA granted Breakthrough Therapy Designation for Pemvidutide, its balanced 1:1 glucagon/GLP-1 dual receptor agonist, for the treatment of metabolic dysfunction-associated steatohepatitis.
Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease characterized by fat accumulation, inflammation, and fibrosis, and can advance to cirrhosis, liver failure, or liver cancer if untreated. It remains one of the leading reasons for liver transplantation in the U.S., with currently approved therapies offering only partial benefit for many patients.
Pemvidutide is designed to target both metabolic and hepatic drivers of disease. By activating glucagon receptors, the therapy aims to reduce liver fat, inflammation, and fibrosis, while GLP-1 receptor activation supports appetite suppression and weight loss.
Altimmune highlighted that Pemvidutide has shown a differentiated clinical profile across multiple measures of liver health and metabolic improvement.
The Breakthrough Therapy Designation was supported by 24-week data from the IMPACT Phase 2b trial, which demonstrated statistically significant MASH resolution without worsening fibrosis, along with early and substantial improvements in liver fat and non-invasive fibrosis markers.
In December 2025, 48-week topline data showed continued improvements in Enhanced Liver Fibrosis (ELF) scores and Liver Stiffness Measurement (LSM), further reduction in liver fat, and additional weight loss at the 1.8 mg dose with no plateau observed. Pemvidutide also maintained a favourable tolerability profile, with fewer discontinuations due to adverse events compared with placebo.
Altimmune recently completed an end-of-phase 2 meeting with the FDA, achieving alignment on the design of a registrational Phase 3 trial. The planned study will evaluate multiple Pemvidutide doses over 52 weeks and incorporate biopsy-based endpoints to support potential accelerated approval. The trial is also expected to use AIM-MASH AI Assist, the first FDA-qualified AI pathology tool for MASH clinical trials.
The company noted that it will also seek scientific advice from European regulators as it finalizes the Phase 3 protocol.
Altimmune is developing Pemvidutide not only for MASH but also for alcohol use disorder (AUD) and alcohol-associated liver disease (ALD), with Phase 2 trials in both indications currently ongoing.
The company ended September 30, 2025, with cash, cash equivalents and short-term investments totaling $210.8 million.
ALT has traded between $2.9 and $7.83 over the past year. The stock closed yesterday's trading at $4.09, up 16.52%, and fell in overnight trading to $4, down 2.20%.
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