Altimmune IncPemvidutide advanced to Phase III for MASH with FDA Breakthrough Therapy and Fast Track designations.

Altimmune has advanced pemvidutide into phase III development for metabolic dysfunction-associated steatohepatitis, or MASH, with the global PERFORMA study now underway. The randomized, placebo-controlled trial will evaluate MASH resolution, fibrosis improvement, and liver-related outcomes in adults with moderate-to-severe liver fibrosis, with 52-week data expected in 2029 and final approval dependent on liver-related events at about 60 months. The company ended June 2026 with $519 million in cash, cash equivalents, and short-term investments, up from $332 million at the end of March, and expects its cash runway to support operations into 2029. Pemvidutide has received Breakthrough Therapy Designation and Fast Track designation from the FDA for MASH, and Altimmune has secured manufacturing capacity for the global phase III study. The company faces competition from Novo Nordisk's semaglutide and Eli Lilly's tirzepatide and retatrutide, which are also in phase III testing for related liver conditions.
Altimmune IncPemvidutide advanced to Phase III for MASH with FDA Breakthrough Therapy and Fast Track designations.
Eli Lilly and Company
Novo Nordisk A/S