Capricor Therapeutics, Inc. faces a securities fraud class action lawsuit covering investors who purchased or acquired CAPR securities from December 17, 2025, through July 26, 2026. Filed in the U.S. District Court for the Southern District of California as Darren Ngasseu Nkamga v. Capricor Therapeutics, Inc., No. 26-cv-04385 (S.D. Cal.), the complaint alleges that Capricor and its defendants made material misstatements or omissions about changes to Deramiocel's pre-specified statistical analysis plan and the FDA's lack of agreement before the company's Biologics License Application resubmission. FDA briefing documents released July 27, 2026, ahead of the agency's July 29 advisory committee meeting said the changes had not been submitted for review before the BLA and were not discussed or agreed upon. The FDA also questioned the scientific basis of converting raw change to percentage change and back again, and said Deramiocel's benefit-risk assessment appeared unfavorable without evidence of effectiveness. Capricor's stock fell 64% after the disclosures. Investors have until September 28, 2026, to seek lead plaintiff status or may remain absent class members. Kessler Topaz Meltzer & Check, LLP is offering free case evaluations on a contingency-fee basis.