Capricor Therapeutics, Inc.
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Background
On July 27, 2026, the US Food and Drug Administration released briefing documents ahead of its advisory committee meeting with Capricor regarding the Company's cell ?therapy for a heart condition related to Duchenne muscular dystrophy.
Among other things, the briefing documents take issue with the manner in which Capricor measured results after the therapy's late-stage trial ended, stating 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 conclude that, among other things, "the benefit-risk assessment for deramiocel appears unfavorable in the absence of evidence of effectiveness."
Cantor Fitzgerald analyst Kristen Kluska published an investor note on the issue, stating the FDA’s “briefing documents paint an ugly picture” and “raise several concerns and make allegations about the integrity of data collecting.”
On this news, shares of Capricor stock declined as much as $12.29, or 62.39%, during intraday trading on July 27, 2026.
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.
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.
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