Capricor Therapeutics announced that the FDA extended the PDUFA target action date for its Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy. The review period was pushed from August 22, 2026 to November 22, 2026 due to the submission of a major amendment containing 24-month open-label extension data from the pivotal Phase 3 HOPE-3 study and additional analyses supporting a refined indication focused on upper limb function. Capricor Therapeutics is a biotechnology company developing cell and exosome-based therapeutics for rare diseases.
