FDA grants three-month extension for Capricor’s Duchenne therapy deramiocel, sets new action date Nov 22

The U.S. Food and Drug Administration has given Capricor Therapeutics a three‑month extension to review additional data for its Duchenne muscular dystrophy cell therapy, deramiocel. The agency has moved the target action date to November 22.

The extension follows a contentious advisory committee meeting in which advisers voted 9‑3 against recommending approval. Capricor responded by submitting an amendment to its biological license application that adds 24‑month open‑label extension data from the Phase 3 HOPE‑3 study and requests a refined indication focused on upper‑limb function, the trial's primary endpoint.

The FDA has classified the submission as a major amendment, resetting the PDUFA date from August 22 to November 22. Capricor’s shares rose as much as 16% after the news, trading around $7.05 per share at the time of reporting.