James (Josh) Wilson, a securities litigation partner at Faruqi & Faruqi, LLP, is leading an investigation into potential legal claims against Capricor Therapeutics, Inc. (NASDAQ: CAPR). The investigation follows a significant decline in Capricor‘s stock price after the company received negative news from the U.S. Food and Drug Administration (FDA).
The firm alleges that Capricor and its executives may have violated federal securities laws. The investigation centers on the company’s statements regarding its lead drug candidate, deramiocel, intended for treating cardiomyopathy linked to Duchenne muscular dystrophy (DMD). Faruqi & Faruqi suggests that the company’s communications to investors regarding deramiocel’s potential for approval and market success were misleading.
Specifically, the complaint asserts that Capricor‘s positive statements about securing a Biologics License Application (BLA) from the FDA for deramiocel were not supported by sufficient evidence. The firm claims that the company failed to adequately disclose concerns about the drug’s safety and efficacy data from its Phase 2 HOPE-2 trial.
The FDA‘s Complete Response Letter (CRL) on July 11, 2025, cited a lack of substantial evidence of effectiveness as the reason for denying the BLA. The CRL also highlighted issues related to the drug’s chemistry, manufacturing, and controls. This announcement led to a notable drop in Capricor‘s share price.
Faruqi & Faruqi is now seeking investors who purchased Capricor securities between October 9, 2024, and July 10, 2025, to contact them. The firm is working to establish a lead plaintiff for a federal securities class action lawsuit. A deadline exists for investors seeking to take on this role.
The firm emphasizes that any investor who chooses to participate in the lawsuit can do so, regardless of whether they serve as lead plaintiff. The lead plaintiff is the investor who has the largest financial interest and will oversee the litigation on behalf of the class. Individuals interested in learning more are encouraged to contact Faruqi & Faruqi.
Faruqi & Faruqi, a national securities law firm with offices in New York, <
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