The litigation, captioned Darren Ngasseu Nkamga v. Capricor Therapeutics, Inc., alleges the company misled shareholders regarding its lead product candidate, Deramiocel. According to the complaint, Capricor modified its statistical analysis plan without securing prior FDA agreement. The discrepancy emerged on July 27, 2026, when the FDA released briefing documents ahead of an advisory committee meeting, explicitly stating the changes were neither discussed nor approved by regulators.

Regulators further challenged the scientific justification behind Capricor’s methodology, noting that the firm’s adjustments added complexity while reducing data accuracy. The briefing concluded that the benefit-risk profile for Deramiocel appeared unfavorable due to a lack of evidence regarding its effectiveness. Kessler Topaz Meltzer & Check, LLP is currently coordinating with affected shareholders to discuss recovery options. Investors are not required to take action to remain part of the class, though those with significant losses may opt to serve as lead plaintiffs by the September deadline.