The complaint, Nkamga v. Capricor Therapeutics, Inc. et al., centers on allegations that Capricor failed to disclose unauthorized changes to the statistical analysis plan used to support its Biologics License Application for Deramiocel. According to the court filing, the company modified its methodology for calculating the PUL 2.0 primary endpoint shortly before unblinding clinical data, a move that reportedly bypassed FDA agreement.

Market confidence collapsed on July 27, 2026, when the FDA released briefing documents questioning the integrity of the data. Shares fell from $19.70 to $7.00, a 64.5% decline. Further losses followed on July 30, when an advisory panel voted 9-3 that available evidence failed to support the drug's efficacy for treating Duchenne muscular dystrophy-associated cardiomyopathy. The law firm Bleichmar Fonti & Auld LLP, which represents the plaintiffs, asserts that these omissions violated the Securities Exchange Act of 1934.