The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will meet on July 29, 2026, to discuss the Biologics License Application (BLA) for Deramiocel. Deramiocel is an investigational cell therapy targeting Duchenne muscular dystrophy (DMD). The PDUFA target action date remains unchanged at August 22, 2026. The BLA is supported by data from the Phase 2 HOPE-2, HOPE-2-OLE, and Phase 3 HOPE-3 trials.