Investors Face September Deadline in Capricor Securities Lawsuit

The lawsuit, filed in the U.S. District Court for the Southern District of California, alleges that Capricor Therapeutics and its executives misled shareholders regarding the development of Deramiocel, a potential treatment for Duchenne muscular dystrophy. According to the complaint, the company altered its pre-specified statistical analysis plan without FDA approval before submitting its Biologics License Application.

Regulatory scrutiny intensified on July 27, 2026, when FDA briefing documents revealed that the final version of the statistical plan was not reviewed by the agency and was created shortly before data unblinding. The FDA questioned the scientific justification for the company's methodology, characterizing the analysis as post-hoc. Following these disclosures and a subsequent advisory committee vote where panelists concluded evidence failed to support the drug's efficacy, Capricor shares experienced successive drops of 64% and 36%. Robbins Geller Rudman & Dowd LLP is representing the class, citing violations of the Securities Exchange Act of 1934.