Capricor Therapeutics Faces Class Action Lawsuits Over Deramiocel Misrepresentation Claims

Capricor Therapeutics Faces Legal Scrutiny Over Deramiocel Claims

Capricor Therapeutics, Inc. is currently embroiled in a series of class action lawsuits stemming from allegations of misleading statements regarding its lead cell therapy candidate, deramiocel, which is intended to treat cardiomyopathy associated with Duchenne muscular dystrophy (DMD). The Gross Law Firm and other legal entities have announced potential legal actions on behalf of shareholders who acquired Capricor shares between October 9, 2024, and July 10, 2025. Central to these allegations is the claim that Capricor misrepresented the safety and efficacy of deramiocel while simultaneously projecting an optimistic outlook for receiving a Biologics License Application (BLA) from the FDA.

The lawsuits assert that Capricor communicated its progress towards FDA approval without disclosing critical adverse safety data from its Phase 2 HOPE-2 trial. Specifically, it is alleged that the company highlighted a mid-cycle review of the BLA that showed no significant deficiencies, misleading investors about the actual status of its clinical trials. The situation escalated on July 11, 2025, when Capricor revealed it had received a Complete Response Letter (CRL) from the FDA, denying the BLA due to insufficient evidence of effectiveness, which subsequently led to a sharp decline in the company’s stock price from $11.40 to $7.64.

The Gross Law Firm is urging affected shareholders to participate in the lawsuits, which aim to address potential violations of the Securities Exchange Act of 1934. Participants are encouraged to register by September 15, 2025, to receive updates on the case. This legal action reflects a broader trend in the biotechnology sector, where transparency and communication regarding clinical trial results are paramount for maintaining investor confidence and safeguarding against potential litigation.

In addition to the Gross Law Firm, the DJS Law Group and the Schall Law Firm have also initiated class action lawsuits against Capricor, emphasizing similar allegations of deceptive practices. These firms are dedicated to enhancing investor rights and ensuring responsible corporate governance. Shareholders interested in pursuing their claims are invited to reach out to these law firms for further information and guidance on joining the legal proceedings.

As Capricor navigates these challenges, the outcomes of these lawsuits could significantly impact its operations and future prospects in the biotechnology landscape, especially concerning its flagship product, deramiocel.