Suit alleges Capricor altered its pre-specified statistical analysis plan for Dermamiocel BLA without FDA review or agreement. Stock dropped 64% on July 27.
A securities class action has been filed against Capricor Therapeutics (CAPR), alleging the company made undisclosed changes to the statistical analysis plan for its experimental heart treatment before submitting the biologics license application to the FDA.
Kaplan Fox & Kilsheimer announced the lawsuit on Aug. 21. It covers investors who bought Capricor shares between Dec. 17, 2025 and July 26, 2026, the defined class period.
The complaint zeroes in on FDA briefing documents released July 27, ahead of the agency's advisory committee meeting on Capricor's resubmitted Dermamiocel BLA. According to those documents, Capricor altered its pre-specified statistical analysis plan. The final version "was not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon," the briefing documents state.
The stock fell $12.70 that day, a 64% drop, to close at $7 per share.
The lead plaintiff deadline is Sept. 28, 2026. Any investor in the proposed class can move the court to serve as lead plaintiff by that date. Participation in the lead plaintiff role is not required to share in any potential recovery.
Kaplan Fox, founded in 1956, has offices in New York, Oakland, Los Angeles, Chicago, and New Jersey. The firm says it has recovered more than $10 billion for clients through securities, antitrust, and consumer protection cases.
The case is pending in the U.S. District Court for the Southern District of New York.
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