Capricor shares plunge 64% after FDA questions deramiocel analysis

  • Rosen Law Firm reminded Capricor investors about the pending securities class action.
  • Capricor shares fell $12.70, or 64%, closing at $7 on July 27, 2026.
  • FDA extended deramiocel’s PDUFA target action date to November 22, 2026.

Capricor Therapeutics faces a securities class action in the U.S. District Court for the Southern District of California over alleged failures to disclose material information during the class period. Rosen Law Firm separately reminded investors who purchased Capricor securities from Dec. 17, 2025, through July 26, 2026, that Sept. 28, 2026, is the deadline to seek appointment as lead plaintiff. The allegations concern changes to the prespecified statistical analysis plan for deramiocel, Capricor’s investigational cell therapy for Duchenne muscular dystrophy, and whether the FDA agreed to those changes before the company resubmitted its biologics license application. Capricor’s shares fell $12.70, or about 64%, to close at $7 on July 27 after FDA briefing documents said the HOPE-3 study had not met its prespecified 12-month efficacy endpoints. The FDA later extended deramiocel’s PDUFA target action date from Aug. 22 to Nov. 22, 2026, after classifying a submission containing 24-month HOPE-3 extension data and a proposed narrower indication as a major amendment. No class has been certified, and investors do not need to seek lead plaintiff status to participate in any potential recovery.

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