Capricor Therapeutics Inc

Quantli Newsdesk

· 19 days ago

The FDA Cellular, Tissue, and Gene Therapies Advisory Committee will convene on July 29, 2026 to review Capricor's application for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy. The BLA is supported by positive Phase 3 HOPE-3 trial results and long-term data from the HOPE-2 extension study. The PDUFA target action date remains August 22, 2026.