Capricor investors face Sept. 28 deadline in securities class action

  • Robbins Geller notified Capricor investors of a September 28 lead-plaintiff deadline.
  • Capricor shares fell 64% on July 27, 2026, according to the complaint.
  • FDA advisers voted 9-3 against evidence supporting Deramiocel efficacy for DMD-associated cardiomyopathy.

Capricor Therapeutics investors have until September 28, 2026, to seek appointment as lead plaintiff in a federal securities class action covering purchases from December 17, 2025, through July 26, 2026. Robbins Geller Rudman & Dowd LLP said the complaint alleges that Capricor and certain executives failed to disclose changes to the prespecified statistical analysis plan for Deramiocel, the company’s investigational cell therapy for Duchenne muscular dystrophy, and that the FDA had not agreed to those changes before the company resubmitted its Biologics License Application. FDA briefing documents released July 27 said the final analysis plan had not been submitted for review or agreed to before the application was filed, while Capricor said the agency relied on an obsolete and incomplete draft. Capricor shares fell 64% on July 27, according to the complaint, and fell 36% after an FDA advisory committee voted 9-3 that available evidence did not support Deramiocel’s efficacy for cardiomyopathy associated with Duchenne muscular dystrophy. The FDA later extended the application’s target action date to November 22, 2026, after receiving 24-month open-label extension data and a request for a narrower upper-limb-function indication.

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