CAPR Investor Alert: Kessler Topaz Meltzer & Check, LLP Encourages CAPR Investors with Losses to Contact the Firm

A securities fraud class action lawsuit has been filed against Capricor Therapeutics, Inc. (Capricor) on behalf of those who purchased or acquired Capricor securities between December 17, 2025 and July 26, 2026, inclusive. Investors have until September 28, 2026, to file for lead plaintiff status. The complaint alleges that, throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material facts about the company's business, operations, and prospects. Specifically, Defendants misrepresented and/or failed to disclose that: (1) Capricor had adopted changes to the pre-specified statistical analysis plan used to analyze Deramiocel clinical data; (2) the FDA had not agreed to these changes prior to Capricor resubmitting the Biologics License Application (" BLA "); (3) the absence of agreement created significant risk that the FDA could conclude that the clinical results of Deramiocel did not provide substantial evidence of its effectiveness, risking its chances for approval; and (4) as a result of the foregoing, Defendants' statements about the company's business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times. On July 27, 2026, the FDA released briefing documents ahead of its July 29 advisory committee meeting for Deramiocel's BLA. The briefing documents revealed that Capricor had made changes to the pre-specified statistical analysis plan and failed to submit the final version to the FDA for review "prior to BLA submission and was not discussed and consequently not agreed upon." The FDA went on to disagree with the changes, 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." The briefing documents continued, detailing that "the benefit-risk assessment for deramiocel appears unfavorable in the absence of evidence of effectiveness." On this news, the price of Capricor stock fell 64%.