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.
Capricor Therapeutics Investors Face September 28 Deadline in Lawsuit
Investors who lost over $100,000 in Capricor Therapeutics securities between December 2025 and July 2026 must act by September 28 to seek lead plaintiff status. The class action suit follows allegations that the company failed to disclose critical discrepancies in its statistical analysis plan for the drug candidate Deramiocel.
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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