New York – September 10, 2026 -- Capricor Therapeutics, Inc. (NASDAQ:CAPR) faces a securities fraud class action after its shares plunged 64.5% following disclosures about alleged undisclosed changes to clinical trial statistics underlying its Duchenne muscular dystrophy therapy application.
Investors allege Capricor concealed statistical plan changes before FDA resubmission
Bleichmar Fonti & Auld LLP filed the suit, captioned Nkamga v. Capricor Therapeutics, Inc. et al., No. 26-cv-04385, in the U.S. District Court for the Southern District of California. The complaint alleges Capricor made false statements regarding Deramiocel, its investigational cell therapy for Duchenne muscular dystrophy, and the integrity of clinical data supporting its Biologics License Application (BLA). According to the filing, Capricor submitted the BLA to the FDA in late 2024, and the agency issued a Complete Response Letter in July 2025 citing insufficient evidence of effectiveness. The complaint claims Capricor failed to disclose that it altered its pre-specified statistical analysis plan without FDA agreement before resubmitting the BLA.
FDA briefing documents trigger 64.5% single-day stock decline on July 27, 2026
On July 27, 2026, FDA briefing documents released ahead of an advisory committee meeting reportedly flagged post-hoc changes to Capricor's statistical methodology, including alterations to calculating the primary endpoint, PUL 2.0, shortly before database unlocking and unblinding. Capricor shares fell $12.70, or 64.5%, from a July 24, 2026 close of $19.70 to $7.00 on July 27, 2026.
Advisory panel votes 9-3 against Deramiocel efficacy, deepening losses
The FDA advisory committee convened on July 29, 2026, to review the Deramiocel BLA. Medscape reported the panel voted 9-3 in a non-binding decision that available evidence did not support Deramiocel's efficacy for treating DMD-associated cardiomyopathy. Capricor stock dropped a further $2.38, or 36%, from $6.57 on July 29, 2026, to $4.19 the following day.
Lead plaintiff deadline set for September 28, 2026
The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 against Capricor and certain senior executives. Investors who purchased Capricor securities have until September 28, 2026, to petition the court for lead plaintiff status. Representation in the matter is being offered on a contingency-fee basis, with no upfront cost to shareholders.