A securities fraud class action has been filed against Capricor Therapeutics, Inc. (NASDAQ: CAPR) and certain officers and directors on behalf of investors who purchased or acquired its securities between December 17, 2025, and July 26, 2026. The suit, captioned Nkamga v. Capricor Therapeutics, Inc. et al., No. 26-cv-04385, is pending in the U.S. District Court for the Southern District of California and asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. Pomerantz LLP and other firms have notified investors of the action. The complaint centers on alleged misstatements about Deramiocel, Capricor’s investigational cell therapy for Duchenne muscular dystrophy, including undisclosed changes to the pre-specified statistical analysis plan for Phase 3 data—among them methodology changes for the primary endpoint PUL 2.0, with the final SAP created one day before unblinding—and that the FDA had not agreed to those changes before BLA resubmission. After a late-2024 BLA filing, the FDA issued a Complete Response Letter in July 2025 citing a lack of substantial evidence of effectiveness; by March 2026 Capricor said it had addressed the CRL issues. On July 27, 2026, FDA briefing documents treated the revised analyses as post-hoc and exploratory and described the benefit-risk assessment as unfavorable; CAPR fell $12.70, or about 64%, to $7.00. After a Medscape report that an FDA advisory committee voted 9-3 that evidence did not support efficacy for DMD-associated cardiomyopathy, the stock dropped another $2.38, or 36%, to $4.19 on July 30, 2026. Investors seeking lead-plaintiff appointment must act by September 28, 2026.