A securities class action has been filed against Capricor Therapeutics, Inc. (CAPR) on behalf of persons and entities that purchased or otherwise acquired Capricor securities between December 17, 2025 through July 26, 2026. This case has been filed in the USDC – SDCA.
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 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, 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 assessment for deramiocel appears unfavorable in the absence of evidence of 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.
On July 29, 2026, the AdCom met to discuss the Deramiocel BLA. The next day, Medscape reported that the panel relied on SAP version 1.1 as the “prespecified plan” and, in a non-binding 9-3 vote, the panel “concluded that the available evidence does not support the efficacy of deramiocel for treating DMD-associated cardiomyopathy.”
On this news, Capricor’s stock fell $2.38, or 36%, to close at $4.19 per share on July 30, 2026, on unusually heavy trading volume.
The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that the Company adopted changes to the pre-specified statistical analysis plan used to analyze clinical data for Deramiocel; (2) that the FDA had not agreed to those changes before the Company resubmitted the Deramiocel BLA; (3) that, as a result, there was a significant risk that the FDA could conclude the clinical results did not provide substantial evidence of effectiveness of Deramiocel; (4) that, as a result of the foregoing, there was a substantial risk to regulatory approval of Deramiocel for the treatment of Duchenne muscular dystrophy; and (5) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.