ODINSIGNAL JOURNAL · NEWS & EVENTS
Capricor’s Deramiocel PDUFA Target Date Set for Nov 22 2026
Deramiocel (CAP‑1002) from Capricor Therapeutics has a FDA PDUFA decision target of 22 Nov 2026 for Duchenne muscular dystrophy.
At a glance
- Date
- 2026-11-22
- Participants
- Capricor Therapeutics Inc.
- Status
- the application remains under review.
Capricor Therapeutics’ cell‑therapy candidate deramiocel (CAP‑1002) is slated for an FDA decision on November 22, 2026. The target date appears on the public PDUFA calendar, which tracks upcoming FDA action dates for biotech products.
The therapy is under review for Duchenne muscular dystrophy (DMD) after Capricor submitted a BLA amendment that added 24‑month open‑label extension data from the Phase 3 HOPE‑3 study. The FDA re‑classified the filing as an extension rather than a Complete Response Letter, so the application remains under review.
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