Capricor investor lawsuit deadline nears amid claims of hidden FDA changes

Capricor Therapeutics faces multiple securities class actions filed on behalf of investors who bought Capricor securities between December 17, 2025 and July 26, 2026, with lead plaintiff deadlines set for September 28, 2026. The lawsuits allege that Capricor and executives concealed changes to the pre-specified statistical analysis plan for the Deramiocel Duchenne muscular dystrophy program and failed to obtain FDA approval of those changes before resubmitting the BLA, amid an FDA briefing that preceded an advisory committee meeting and a 64% stock drop to $7.00 on July 27, 2026. Law firms including Kaplan Fox & Kilsheimer, Berger Montague, Robbins Geller Rudman & Dowd, and Hagens Berman are pursuing lead plaintiff roles and securities claims under the Securities Exchange Act of 1934. The complaints argue the alleged misstatements and changes created substantial regulatory and clinical risk, potentially affecting Deramiocel’s path to approval. Separately, the FDA extended Capricor’s BLA review period, moving the PDUFA action date from August 22, 2026 to November 22, 2026, underscoring ongoing regulatory scrutiny. Capricor’s lead product candidate is Deramiocel, a cell therapy aimed at Duchenne muscular dystrophy, around which the litigation centers.