Security Investigation
Capricor Therapeutics, Inc. (NasdaqGS: CAPR)
59 Days left to seek lead plaintiff status.
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Kahn Swick & Foti, LLC (“KSF”) and KSF partner, former Attorney General of Louisiana, Charles C. Foti, Jr., notifies investors in Capricor Therapeutics, Inc. (“Capricor” or the “Company”) (NasdaqGS: CAPR) of a class action securities lawsuit.
According to the Complaint, 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.
If you invested in Capricor and suffered a loss during the relevant time frame, you have until September 28, 2026 to request that the Court appoint you as lead plaintiff; however, your ability to share in any recovery does not require that you serve as a lead plaintiff. Capricor investors should contact KSF Managing Partner Lewis Kahn toll-free at (877) 515-1850 or via email (lewis.kahn@ksfcounsel.com), or fill out the form on this page.
The case is Nkamga v. Capricor Therapeutics, Inc., et al., No. 3:26-cv-04385.