Capricor shares jump as FDA signals openness to review updated Duchenne therapy

Capricor Therapeutics saw its stock rise sharply after CEO Linda Marbán told analysts that the FDA is willing to look at an amended filing for its Duchenne muscular dystrophy cell therapy, deramiocel.

The company previously faced a negative vote from an FDA advisory panel on the therapy’s use for Duchenne-related cardiomyopathy, though the panel was more supportive of potential benefits for upper‑limb function.

Marbán said Capricor will submit new follow‑up data to refine the indication, and the agency has set an August 22 deadline for a decision on the updated submission.

The news coincided with Cytokinetics filing a lawsuit against Bristol Myers Squibb over a heart‑drug dispute, and Rigel Pharmaceuticals announced pricing for its first PROTAC‑based medicine, but the share move was driven by the FDA update.