The legal action, pending in the U.S. District Court for the Southern District of California, centers on a July 2026 FDA briefing document. Regulators revealed that Capricor modified its statistical analysis plan for Deramiocel just one day before data was unblinded. The FDA characterized these changes as post-hoc and exploratory, noting they lacked scientific justification and undermined the accuracy of the trial results.
Following the disclosure, Capricor shares plummeted 64%, shedding $12.70 to close at $7.00 per share. The lawsuit, Nkamga v. Capricor Therapeutics, Inc., claims these omissions violated federal securities laws by misrepresenting the company's progress and clinical data to the market. Investors seeking to evaluate their legal options or participate in the litigation can contact the firm Kahn Swick & Foti, LLC or visit the ClaimsFiler portal.
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