Capricor Therapeutics faces FDA regulatory shifts and securities lawsuit

Capricor Therapeutics is navigating regulatory and legal challenges regarding its investigational cell therapy, deramiocel, intended for Duchenne muscular dystrophy (DMD). The company is preparing to submit an amendment to the U.S. Food and Drug Administration (FDA) to refine the drug's indication, shifting focus toward upper limb skeletal muscle function rather than cardiomyopathy. This follows an FDA advisory committee vote where members voted against finding substantial evidence of deramiocel’s effectiveness for treating cardiomyopathy.

Simultaneously, Capricor is facing a federal securities class action lawsuit, Nkamga v. Capricor Therapeutics, Inc. The lawsuit, filed in the U.S. District Court for the Southern District of California, alleges that the company and its leadership made false or misleading statements regarding the regulatory prospects of deramiocel. The legal action represents investors who purchased Capricor securities between December 17, 2025, and July 26, 2026.