Capricor investors face Sept. 28 lead plaintiff deadline after 64% stock drop

  • Capricor investors can seek lead plaintiff appointment in the proposed securities class action.
  • 64%: Capricor shares fell to $7 after FDA briefing documents were published July 27, 2026.
  • FDA extended Deramiocel’s PDUFA action date from Aug. 22 to Nov. 22, 2026.

Capricor Therapeutics investors who purchased or acquired the company’s securities between Dec. 17, 2025, and July 26, 2026, have until Sept. 28, 2026, to seek appointment as lead plaintiff in the proposed securities class action Nkamga v. Capricor Therapeutics, Inc., No. 26-cv-04385, in the U.S. District Court for the Southern District of California. The lawsuit alleges that Capricor and certain executives failed to disclose changes to the pre-specified statistical analysis plan for Deramiocel, its investigational cell therapy for Duchenne muscular dystrophy, before resubmitting its Biologics License Application, or BLA. FDA briefing documents released July 27 said the HOPE-3 study did not meet its pre-specified primary and secondary efficacy endpoints at 12 months, while an advisory committee later voted 9-3 against the drug’s efficacy. Capricor shares fell about 64% to $7 on July 27 and declined another 36% after the advisory committee meeting, according to the complaint. On Aug. 24, Capricor said the FDA had extended the PDUFA target action date for Deramiocel from Aug. 22 to Nov. 22, 2026, after classifying a submission containing 24-month open-label extension data from the Phase 3 HOPE-3 study and a request to focus the proposed indication solely on upper limb function as a major amendment. The complaint also concerns Capricor’s Dec. 3, 2025 announcement of positive topline HOPE-3 results, which was followed by a 370% share-price surge and a public offering of about 6 million shares at $25 each the next day. Hagens Berman Sobol Shapiro LLP is notifying affected investors and says they do not need to seek lead plaintiff status to participate in any potential recovery.

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