Capricor Therapeutics Announces FDA PDUFA Extension for Deramiocel

What Happened
On August 24, 2026 Capricor Therapeutics, Inc. (CAPR) announced via Form 8-K and a press release that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) target action date for its Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD). The PDUFA date moved from August 22, 2026 to November 22, 2026 after the FDA classified the submission as a “major amendment,” which extends the review by three months. The amendment includes 24‑month open‑label extension data from Capricor’s pivotal Phase 3 HOPE‑3 study and additional analyses supporting a refined proposed indication focused on upper‑limb function (the HOPE‑3 primary endpoint).

Key Details

• FDA extended PDUFA target action date from August 22, 2026 to November 22, 2026 (three‑month extension).
• FDA classified the BLA submission as a “major amendment,” triggering the extension.
• Amendment includes 24‑month open‑label extension data from the pivotal Phase 3 HOPE‑3 study.
• Capricor requested FDA review of existing and new data to support a refined proposed indication focused on upper‑limb function (the primary endpoint of HOPE‑3).

Why It Matters
The extension delays the FDA’s final action on Deramiocel until November 22, 2026, shifting the timeline for any potential approval and commercialization. The company has submitted additional long‑term HOPE‑3 data and analyses that are being considered by the FDA; those materials are being reviewed as part of the major amendment. Investors should note this is an extension of review (not an approval or denial) and monitor further company updates and the FDA decision for implications to Deramiocel’s potential market opportunity and timing.