Kuznicki Law PLLC notifies investors that a class action has commenced in the United States District Court for the Southern District of California on behalf of shareholders of Capricor Therapeutics, Inc. who purchased shares between December 17, 2025 and July 26, 2026.
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 wish to choose counsel to represent you and the class, you must apply to be appointed lead plaintiff and be selected by the Court. The lead plaintiff will direct the litigation and participate in important decisions including whether to accept a settlement for the class in the action. The lead plaintiff will be selected from among applicants claiming the largest loss from investment in the respective securities during the class periods. Members of the class will be represented by the lead plaintiff and counsel chosen by the lead plaintiff. No class has yet been certified in the above action. Appointment as Lead Plaintiff is not required to partake in any recovery.
Shareholders have until September 28, 2026 to request that the court appoint them lead plaintiff.