Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
FDA decision (PDUFA) target Nov 22, 2026 · Capricor Therapeutics Inc. · Duchenne Muscular Dystrophy (DMD)
Date extended: announced August 24, 2026. The FDA moved this target action date from August 22, 2026 to November 22, 2026. After the July 2026 advisory committee meeting Capricor submitted a BLA amendment containing 24-month open-label extension data from the pivotal Phase 3 HOPE-3 study and additional analyses, supporting a refined proposed indication focused on upper limb function: the trial’s primary endpoint. The FDA classified it a major amendment and added three months to review it. This is an extension, not a Complete Response Letter: the application remains under review. Capricor’s announcement.
The FDA PDUFA target date for CAPR (Capricor Therapeutics Inc.) is 2026-11-22 for Deramiocel (CAP-1002). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is CAPR's drug Deramiocel?
Deramiocel (CAP-1002) is Capricor Therapeutics Inc.'s candidate under FDA review for Duchenne Muscular Dystrophy (DMD).