The litigation, filed in the U.S. District Court for the Southern District of California, centers on allegations that Capricor executives failed to disclose critical changes to the statistical analysis plan for Deramiocel, a therapy intended to treat Duchenne muscular dystrophy. According to the lawsuit, the FDA had not vetted these modifications before the company submitted its Biologics License Application, creating significant uncertainty regarding the drug's efficacy.

Market volatility intensified on July 27, 2026, when the FDA released briefing documents questioning the scientific justification of Capricor's data analysis. Shares plummeted 64% following the disclosure. The situation worsened on July 30, when an advisory committee voted 9-3 that available evidence failed to support the drug's efficacy for DMD-associated cardiomyopathy, triggering a further 36% decline in the stock price. Investors seeking to participate in the legal proceedings are represented by the firm Robbins Geller Rudman & Dowd LLP.