Capricor Therapeutics investors have until Sept 28 to join lawsuit over deramiocel setbacks
SAN FRANCISCO, Sept. 1, 2026 /CourierPR/ -- Capricor Therapeutics, Inc. (NASDAQ: CAPR) investors who suffered substantial losses due to the company's stock price fluctuations following a series of regulatory and clinical developments now have until September 28, 2026, to join a pending securities class action lawsuit, a law firm has announced.
The U.S. Food and Drug Administration (FDA) recently extended the review period for Capricor's Biologics License Application (BLA) for its lead investigational cell therapy, deramiocel, for the treatment of Duchenne muscular dystrophy (DMD). This decision, made on August 24, 2026, has underscored ongoing regulatory and disclosure scrutiny surrounding the company.
Hagens Berman Sobol Shapiro LLP, a national plaintiffs' rights law firm, is alerting investors in Capricor Therapeutics, Inc. of the opportunity to potentially lead a shareholder class action lawsuit. The firm encourages investors who suffered significant losses to contact them now.
The FDA’s decision followed a turbulent Advisory Committee meeting in July 2026. Capricor announced positive topline results from its Phase 3 HOPE-3 study on December 3, 2025, with the company’s CEO stating that deramiocel could meaningfully improve Duchenne muscular dystrophy, leading to a 370% surge in the company's share price. However, the HOPE-3 results revealed unagreed-upon post-hoc modifications to the pre-specified Statistical Analysis Plan (SAP), which the FDA stated did not meet the pre-specified primary and secondary efficacy endpoints. Capricor's share price subsequently plummeted 64% the following day.
The lawsuit alleges that Capricor and certain executives made materially false and misleading statements regarding the clinical trial data and regulatory pathway for deramiocel. Specifically, it is alleged that the company failed to disclose that it adopted changes to the pre-specified SAP without the FDA's approval prior to resubmitting its BLA.
Reed Kathrein, the partner leading the firm’s investigation, emphasized the need to uncover the full scope of management’s characterization of these trial endpoints and any undisclosed modifications. Investors who purchased or acquired Capricor securities between December 17, 2025, and July 26, 2026, and suffered significant financial losses are encouraged to act quickly to join the lawsuit.
Whistleblowers with non-public information about Capricor are also encouraged to contact the firm for potential rewards under the SEC Whistleblower program.
Hagens Berman Sobol Shapiro LLP is a global plaintiffs' rights complex litigation firm focusing on corporate accountability and representing investors, whistleblowers, workers, consumers, and others in cases that achieve real results for those harmed by corporate negligence and other wrongdoings.