The lawsuit, Nkamga v. Capricor Therapeutics, Inc., et al., alleges that the company and its executives failed to disclose material information regarding the clinical trial analysis for its lead product, Deramiocel. On July 27, 2026, the FDA released briefing documents revealing that Capricor had altered its statistical analysis plan without regulatory agreement. The agency characterized these post-study adjustments as exploratory and lacking scientific justification, noting that the changes undermined the accuracy of the trial data.

Following the disclosure, Capricor shares dropped $12.70, or 64%, to close at $7.00 on July 27, 2026. The law firm Kahn Swick & Foti, LLC, which is leading the litigation, claims that these omissions violated federal securities laws. Investors seeking to participate in the recovery effort or obtain further information can contact managing partner Lewis Kahn at 1-833-538-3666.