NEW ORLEANS, Sept. 18, 2026 /PRNewswire/ — ClaimsFiler, a FREE shareholder information service, reminds investors that they have until September 28, 2026 to file lead plaintiff applications in a securities class action lawsuit against Capricor Therapeutics, Inc. (“Capricor” or the “Company”) (NasdaqGS: CAPR), if they purchased Capricor securities between December 17, 2025 and July 26, 2026, inclusive (the “Class Period”). This action is pending in the United States District Court for the Southern District of California.
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Capricor investors should visit us at https://claimsfiler.com/cases/nasdaq-capr-2/ or call toll-free (833) 538-3604. Lawyers at Kahn Swick & Foti, LLC are available to discuss your legal options.
About the Lawsuit
Capricor and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws.
On July 27, 2026, pre-market, the U.S. Food and Drug Administration (“FDA”) published briefing documents ahead of its July 29 advisory committee meeting to review the Biologics License Application (“BLA”) for the Company’s lead product candidate, Deramiocel, finding that the Company 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.” Importantly, the final SAP was finalized just one day before the data was unblinded. The FDA disagreed with the changes made to the SAP, explaining that converting raw change to percent change and back again added unnecessary complexity and undermined accuracy, without scientific justification for doing so. As a result, the FDA stated that it “considers [Capricor’s] analyses based on the post-study SAP versions to be post-hoc and exploratory.” According to the briefing documents, the benefit-risk profile for deramiocel looked unfavorable given the lack of evidence supporting its effectiveness.
On this news, Capricor’s stock fell $12.70, or 64%, to close at $7.00 per share on July 27, 2026, on unusually heavy trading volume
The case is Nkamga v. Capricor Therapeutics, Inc., et al., No. 3:26-cv-04385.
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