Capricor Therapeutics Faces Class Action Lawsuit After Stock Plunge

The legal action, captioned Darren Ngasseu Nkamga v. Capricor Therapeutics, Inc., claims that Capricor made material misstatements concerning its lead product candidate, Deramiocel. According to the complaint, the company allegedly altered its pre-specified statistical analysis plan without securing prior agreement from the FDA. This lack of coordination reportedly created significant regulatory risks that were not disclosed to the public, threatening the drug’s chances for approval.

Market confidence in Capricor collapsed on July 27, 2026, following the release of FDA briefing documents. The agency revealed that the company’s changes to the statistical plan were not scientifically justified and that the benefit-risk assessment for Deramiocel appeared unfavorable due to a lack of evidence regarding its effectiveness. Shares of Capricor plummeted 64% in response to the disclosure. Investors seeking to serve as lead plaintiff in the litigation must file their motions with the court by September 28, 2026.