Capricor Therapeutics IncFDA briefing documents revealed changes to statistical analysis plan without FDA review, leading to class action lawsuit and 64% stock drop.

Kaplan Fox & Kilsheimer LLP has filed a class action lawsuit against Capricor Therapeutics on behalf of investors who purchased Capricor securities between December 17, 2025 and July 26, 2026. The complaint alleges that on July 27, 2026, the FDA released briefing documents ahead of an advisory committee meeting for Capricor’s resubmitted Dermamiocel Biologics License Application, revealing that the company made changes to the pre-specified statistical analysis plan without FDA review or agreement. Following the disclosure, Capricor’s stock price fell $12.70, or 64%, to close at $7 per share. Investors have until September 28, 2026 to seek lead plaintiff status.
Capricor Therapeutics IncFDA briefing documents revealed changes to statistical analysis plan without FDA review, leading to class action lawsuit and 64% stock drop.
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