Capricor Therapeutics Faces Class Action Lawsuit After Stock Plunge

The lawsuit, filed in the U.S. District Court for the Southern District of California under the caption Nkamga v. Capricor Therapeutics, Inc. et al., claims the company violated federal securities laws by failing to disclose unauthorized changes to its statistical analysis plan for Deramiocel. According to the complaint, these alterations were made to the methodology for calculating the primary endpoint, PUL 2.0, without prior agreement from the FDA.

The market reacted violently to these revelations. On July 27, 2026, Capricor shares fell 64.5%, dropping from $19.70 to $7.00 per share, after the FDA released briefing documents highlighting concerns over the data integrity. Further pressure mounted on July 30, 2026, when a panel of FDA advisors voted 9-3 that the existing evidence failed to support the drug's efficacy for treating Duchenne muscular dystrophy-associated cardiomyopathy, causing the stock to slide an additional 36%.

Investors who purchased Capricor securities have until September 28, 2026, to apply for lead plaintiff status in the case, which is being led by the law firm Bleichmar Fonti & Auld LLP. The litigation seeks to address losses sustained by shareholders under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.