Altimmune receives FDA breakthrough therapy designation for pemvidutide in MASH

Altimmune

5 January 2026 - Alignment on Phase 3 registrational trial parameters confirmed following receipt of minutes from end of phase 2 meeting with US FDA.

Altimmune today announced the US FDA has granted breakthrough therapy designation for pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, for the treatment of patients with metabolic dysfunction-associated steatohepatitis.

Read Altimmune press release

Michael Wonder

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Michael Wonder