Altimmune Targets Second-Half 2026 Launch for Global Phase 3 MASH Trial

Overview

• Altimmune said it plans to start PERFORMA, a global Phase 3 study of pemvidutide in metabolic dysfunction–associated steatohepatitis, in the second half of 2026.
• The company finalized the PERFORMA protocol, submitted it to the FDA, and aligned the design with guidance from the EMA.
• The trial includes a 52-week interim liver biopsy analysis intended to support an accelerated approval filing.
• An oversubscribed $225 million offering lifted cash to about $535 million, which management says should cover operations through the planned 2029 Phase 3 readout.
• Altimmune points to pemvidutide’s tolerability and weight-loss effects as potential advantages, with Phase 2 IMPACT data due at the EASL meeting next month and RECLAIM topline results expected next quarter.