Capricor Therapeutics, Inc. (NASDAQ: CAPR)

This lawsuit is for anyone who acquired securities in Capricor Therapeutics, Inc. (NASDAQ: CAPR) from December 17, 2025 through July 26, 2026.

The lawsuit alleges that the Company and certain of its executives violated federal law. Specifically, the lawsuit alleges that, throughout the time period mentioned above, the Company misled investors regarding its financial condition. More specifically, the lawsuit alleges that the Company misled investors by making positive statements about the Company’s Duchenne muscular dystrophy drug, Deramiocel, and thereby the likelihood of FDA approval, when the Company was collecting clinical data on the drug in a manner that the Company knew, or should have known, the FDA would not accept.

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, the price of the Company’s stock dropped precipitously on unusually heavy trading volume.

The Law Offices of Howard G. Smith seeks to recover damages on behalf of class members. If you acquired securities in Capricor Therapeutics, Inc. (NASDAQ: CAPR) from December 17, 2025 through July 26, 2026 you may join the lawsuit by submitting your information online, or you may call the Law Offices of Howard G. Smith and speak to Mr. Smith directly to learn how he can protect your rights.