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 failed to disclose unauthorized changes to its statistical analysis plan. According to the complaint, these methodology shifts for the primary endpoint, PUL 2.0, were implemented shortly before database unblinding without FDA approval.

Market confidence evaporated on July 27, 2026, when FDA briefing documents revealed these discrepancies, sending Capricor shares tumbling from $19.70 to $7.00. The situation worsened on July 30, 2026, after an FDA advisory committee voted 9-3 that available evidence failed to support the drug's efficacy for Duchenne muscular dystrophy-associated cardiomyopathy, causing an additional 36% share price decline. Investors seeking to serve as lead plaintiff in the litigation have until September 28, 2026, to petition the court.