Our pipeline is currently anchored in pemvidutide*, a novel dual-action investigational therapy engineered to target both the cause and the consequence of serious liver disease. With a single differentiated molecule, we are advancing programs across metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD).
PIPELINE
One Investigational Therapy. Multiple Fronts Against Serious Liver Disease
Our Priority Programs in Serious Liver Diseases
Pemvidutide, our dual-action investigational therapy, is advancing across metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). In August 2026, we announced the initiation of the PERFORMA Phase 3 trial in MASH, which we plan to have serve as our registrational study for pemvidutide for that indication.
Altimmune also continues to advance development of pemvidutide for AUD and ALD. In July 2026, we reported positive Phase 2 topline data from the RECLAIM Phase 2 trial in AUD. In August 2026, we announced the completion of patient enrollment in the RESTORE Phase 2 trial in ALD.
The U.S. Food and Drug Administration granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH, underscoring both the significant unmet need in these diseases and the potential of our investigational therapy.
MASH
(FDA Fast Track Designation)
(FDA Breakthrough Therapy Designation)
(FDA Breakthrough Therapy Designation)
4Q25: IMPACT Phase 2b 48w data
4Q25: End of Phase 2 FDA meeting complete
2H26: PERFORMA Phase 3 trial initiated
AUD
(FDA Fast Track Designation)
4Q25: RECLAIM Phase 2 trial enrollment complete
3Q26: RECLAIM Phase 2 topline data
ALD
3Q26: RESTORE Phase 2 trial enrollment complete
2H27: RESTORE Phase 2 trial topline data
MASH: metabolic dysfunction-associated steatohepatitis
AUD: alcohol use disorder
ALD: alcohol-associated liver disease
*Pemvidutide is investigational and has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. Safety and efficacy have not been established. There is no guarantee that it will successfully complete clinical development or receive regulatory approval.
