Pomerantz LLP Alerts Shareholders to Investor Suit Against Capricor Therapeutics, Inc. - CAPR

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Pomerantz LLP Alerts Shareholders to Investor Suit Against Capricor Therapeutics, Inc. – CAPRNEW YORK CITY, NY / ACCESS Newswire / August 17, 2026 / Pomerantz LLP announces that a class action lawsuit has been filed against Capricor Therapeutics, Inc. ("Capricor" or the "Company") (NASDAQ:CAPR). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.The class action concerns whether Capricor and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.You have until September 28, 2026, to ask the Court to appoint you as Lead Plaintiff for the class if you purchased or otherwise acquired Capricor securities during the Class Period. A copy of the Complaint can be obtained at www.pomerantzlaw.com.[Click here for information about joining the class action]In late 2024, Capricor submitted its Biologics License Application ("BLA") to the U.S. Food and Drug Administration for Deramiocel as a cell therapy for the treatment of Duchenne muscular dystrophy. In July 2025, the FDA issued a Complete Response Letter because it could not approve the BLA in its current form. According to the Company, the CRL cited "that the BLA does not meet the statutory requirement for substantial evidence of effectiveness and the need for additional clinical data." By March 2026, Capricor claimed it had addressed the issues identified in the CRL.On July 27, 2026, before the market opened, the U.S. Food and Drug Administration ("FDA") released briefing documents ahead of its July 29 advisory committee ("AdCom") meeting for the BLA. According to the briefing documents, Capricor made changes to the pre-specified statistical analysis plan ("SAP") and that the final version "was not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon." Critically, the final SAP was created one day before the data was unblinded. The FDA disagreed with the changes made to the SAP, stating that the "FDA does not consider the conversion of raw change to percent change and then back to raw change to have been scientifically justified, as it adds complexity and reduces accuracy." As a result,...

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