Altimmune Advances Pemvidutide with FDA Breakthrough Designation and Phase 3 MASH Trial Planned
Altimmune's pemvidutide received FDA Breakthrough Therapy Designation for MASH treatment, with Phase 3 trial initiation planned for 2026. The company raised $75 million in January 2026 to fund development.
Altimmune announced the initiation of a Phase 3 MASH trial planned for 2026, following the FDA's grant of Breakthrough Therapy Designation to pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH). The FDA also granted Fast Track designations to pemvidutide for the treatment of MASH and alcohol use disorder (AUD).
The company reported cash, cash equivalents and short-term investments of $274 million as of December 31, 2025. On January 29, Altimmune closed a direct offering of 17.05 million shares of common stock, generating $75 million in gross proceeds. The company plans to use net proceeds from the offering to fund the upcoming Phase 3 trial of 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.
In December 2025, the company announced 48-week data from the IMPACT Phase 2b trial in MASH. Pemvidutide hit its main primary endpoint of MASH resolution without worsening of fibrosis (liver scarring). However, the other endpoint of improvement in fibrosis was not statistically significant in those who took the medicine compared to those who took a placebo.
The company is actively finalizing the study plan for the Phase 3 trial of pemvidutide in MASH. Topline data from the RECLAIM Phase 2 trial of pemvidutide in alcohol use disorder (AUD) is expected in the third quarter of 2026. The Phase 2 RECLAIM trial in AUD and RESTORE trial in ALD were initiated in May 2025 and July 2025, respectively, and are currently ongoing.
On February 13, Titan Partners initiated coverage with a Buy rating and a $7 target. On January 27, Evercore ISI reiterated an Outperform rating and cut the price target to $22 from $25. Despite the price target cut, the research firm remains confident about the company's long-term prospects, driven by pemvidutide.
Altimmune is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases.