Capricor Therapeutics Faces Class Action Suit Following FDA Review

The legal action centers on allegations that Capricor and its executives engaged in securities fraud related to the development of Deramiocel, a cell therapy intended for Duchenne muscular dystrophy. Trouble began in July 2025 when the FDA issued a Complete Response Letter, citing a lack of substantial evidence regarding the therapy's effectiveness. Although Capricor claimed by March 2026 to have resolved these concerns, internal FDA documents released on July 27 revealed that the company had modified its statistical analysis plan without regulatory oversight.

Regulators noted that the final plan was drafted just one day before data was unblinded. The FDA criticized these changes as scientifically unjustified and labeled the company's resulting analyses as exploratory rather than definitive. Following the release of these documents, Capricor shares plummeted 64% to $7.00. The situation intensified on July 29, when an advisory committee voted 9-3 that the available data failed to support the drug's efficacy for treating DMD-associated cardiomyopathy. Shares dropped an additional 36% the following day, closing at $4.19.