Pemvidutide - (RECLAIM)

May 13, 2026: Altimmune, Inc. (NASDAQ: ALT) reported Q1 2026 financial results and provided program updates for pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD).

MASH (pemvidutide): FDA granted Breakthrough Therapy Designation based on 24-week data from the Phase 2b IMPACT trial; Fast Track designation is also noted. Altimmune plans to initiate the global PERFORMA Phase 3 registrational MASH trial in 2H 2026; the protocol has been finalized and submitted to FDA, and the design is aligned with FDA/EMA feedback. A 52-week data readout is anticipated in 2029. Additional IMPACT data will be presented at EASL Congress 2026, including a late-breaking oral presentation of 48-week MASH data on May 28, 2026 (selected as “Best of EASL 2026”) plus multiple posters.

AUD (pemvidutide): Topline data from the RECLAIM Phase 2 trial are expected in Q3 2026; the ~100-patient, 24-week study completed enrollment in November 2025.

ALD (pemvidutide): The RESTORE Phase 2 (~100-patient, 48-week) trial is ongoing; enrollment completion is expected in Q3 2026.