The lawsuit, Nkamga v. Capricor Therapeutics, Inc., filed in the Southern District of California, alleges that the biotechnology firm misled shareholders regarding its statistical analysis plan for Deramiocel, a therapy intended to treat Duchenne muscular dystrophy. According to the complaint, Capricor modified its analysis plan without securing FDA approval, creating significant regulatory hurdles for the drug’s approval.

FDA briefing documents released on July 27, 2026, revealed that the agency viewed Capricor's post-study statistical methods as exploratory rather than definitive. Following these disclosures and a subsequent advisory committee vote where panelists questioned the efficacy of the treatment, Capricor’s stock dropped by 64% and 36% over consecutive trading sessions. The firm Robbins Geller Rudman & Dowd LLP is representing the class, inviting investors who suffered significant losses during the specified period to participate in the legal action.