Capricor Therapeutics Faces Class Action Over Deramiocel Data Integrity

The lawsuit, Nkamga v. Capricor Therapeutics, Inc. et al., filed in the U.S. District Court for the Southern District of California, accuses the company and its senior executives of securities fraud. Plaintiffs claim Capricor failed to disclose that it altered its pre-specified statistical analysis plan—specifically the methodology for the PUL 2.0 primary endpoint—without prior FDA agreement before resubmitting its Biologics License Application.

The fallout intensified on July 27, 2026, when FDA briefing documents revealed concerns over these post-hoc methodological shifts. Shares plunged from $19.70 to $7.00, a 64.5% decline. Market pressure persisted days later when an FDA advisory committee voted 9-3 that available evidence failed to support the drug's efficacy for treating DMD-associated cardiomyopathy, driving the stock down an additional 36% to $4.19. Investors seeking to serve as lead plaintiff in the case have until September 28, 2026, to petition the court.