The complaint, filed in the U.S. District Court for the Southern District of California, centers on claims that Capricor misled stakeholders regarding the integrity of clinical data submitted within its Biologics License Application. According to the lawsuit, the company modified its pre-specified statistical analysis—specifically the methodology for the PUL 2.0 primary endpoint—without securing prior FDA agreement. These undisclosed adjustments came to light when the FDA released briefing documents on July 27, 2026, revealing that the database was altered shortly before being unlocked.

Market reaction was immediate and severe. Capricor shares plummeted from $19.70 to $7.00 per share on the day of the disclosure. The situation deteriorated further on July 30, 2026, following a non-binding 9-3 vote by an FDA advisory committee, which concluded that current evidence failed to support the drug's efficacy for treating DMD-associated cardiomyopathy. This subsequent news triggered an additional 36% decline in stock price. Investors seeking to serve as lead plaintiff in the Nkamga v. Capricor Therapeutics, Inc. case have until September 28, 2026, to file with the court.