The legal action, Nkamga v. Capricor Therapeutics, Inc., claims executives violated the Securities Exchange Act of 1934 by failing to disclose critical discrepancies in their statistical analysis plan (SAP). According to the complaint, Capricor modified its analysis methods without FDA approval prior to submitting its Biologics License Application. Regulatory briefing documents released on July 27, 2026, revealed the FDA viewed these post-hoc analyses as scientifically unjustified, sparking a 64% collapse in the company’s stock price.

Following these revelations, an FDA advisory committee voted 9-3 on July 29, 2026, to conclude that available evidence failed to support the drug's efficacy for treating cardiomyopathy associated with Duchenne muscular dystrophy. This negative assessment triggered a further 36% decline in share value. The lawsuit, filed by Robbins Geller Rudman & Dowd LLP, contends that the company’s public assurances of transparency regarding its interactions with regulators were misleading. Investors seeking to participate in the litigation may contact attorneys Ken Dolitsky or Michael Albert to discuss their financial interest in the case.