Capricor Therapeutics Shareholder Class Action Nears Deadline
Investors in Capricor Therapeutics who incurred substantial losses have an opportunity to join an ongoing securities class action. The deadline to be appointed lead plaintiff is September 28, 2026.
Investors who have suffered significant losses in Capricor Therapeutics, Inc. (NASDAQ: CAPR) may have the opportunity to participate in an ongoing securities class action lawsuit. The law firm Hagens Berman Sobol Shapiro LLP has announced that the deadline for investors to be appointed lead plaintiff is September 28, 2026.
The lawsuit alleges that Capricor and certain executives made materially false and misleading statements regarding the clinical trial data and regulatory pathway for its lead product candidate, deramiocel. Deramiocel is intended for the treatment of Duchenne muscular dystrophy (DMD).
Concerns escalated when the U.S. Food and Drug Administration (FDA) announced in August 2026 an extension of the review period for Capricor's Biologics License Application (BLA) for deramiocel. This followed a meeting of the FDA's Advisory Committee, where it was revealed that Capricor had made changes to its pre-specified Statistical Analysis Plan (SAP) without FDA agreement prior to resubmitting its BLA. The FDA stated the HOPE-3 study "did not meet its pre-specified primary and secondary efficacy endpoints showing no statistically significant difference between deramiocel and placebo at 12 months."
Capricor had announced positive topline results from its Phase 3 HOPE-3 study in December 2025, which led to a substantial increase in its stock price. The company also conducted a stock offering. However, the situation shifted in July 2026 when the FDA released briefing documents revealing the SAP modifications and the lack of statistically significant findings. Consequently, Capricor's stock price plummeted approximately 64% in a single day.
Attorney Reed Kathrein, leading Hagens Berman's investigation, stated that their focus is on investor losses and uncovering the full scope of management's characterizations of the trial data and undisclosed modifications. Investors who purchased Capricor securities between December 17, 2025, and July 26, 2026, and experienced significant financial losses are urged to contact the law firm before the September 28, 2026 deadline.