Capricor Therapeutics Faces Class Action Lawsuit After Clinical Data Dispute

The lawsuit, filed in the U.S. District Court for the Southern District of California, centers on claims that Capricor executives failed to disclose unauthorized changes to the statistical analysis plan used to support the company’s Biologics License Application. According to the complaint, these methodology shifts were implemented shortly before database unlocking, without prior FDA approval.

Market volatility intensified on July 27, 2026, when FDA briefing documents revealed concerns over the trial's primary endpoint, PUL 2.0. The disclosure wiped $12.70 from the share price in a single session. Further scrutiny followed an FDA advisory committee meeting on July 29, where panelists voted 9-3 that the existing evidence failed to demonstrate the efficacy of Deramiocel for DMD-associated cardiomyopathy. This subsequent news triggered an additional 36% decline in valuation.

Investors seeking to be appointed as lead plaintiff in the case, captioned Nkamga v. Capricor Therapeutics, Inc. et al., must file their applications by September 28, 2026. Legal counsel from Bleichmar Fonti & Auld LLP is representing the class, asserting claims under the Securities Exchange Act of 1934.