The legal action, filed in the U.S. District Court for the Southern District of California, alleges that Capricor failed to disclose critical modifications to its statistical analysis plan. According to the complaint, these changes—which were not vetted by the FDA before the company resubmitted its Biologics License Application—involved the methodology for calculating the primary endpoint, PUL 2.0, shortly before the database was unblinded.

The scrutiny intensified on July 27, 2026, when FDA briefing documents revealed concerns over these post-hoc adjustments. The market reaction was immediate and severe, with Capricor shares plummeting from $19.70 to $7.00 in a single trading day. Further pressure mounted 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, triggering another 36% decline in stock value.

Bleichmar Fonti & Auld LLP, the firm representing the class, asserts that these actions violated the Securities Exchange Act of 1934. Shareholders seeking to be appointed as lead plaintiff in Nkamga v. Capricor Therapeutics, Inc. et al. must file their requests by the end of September.