Los Angeles, Calif. — A class action lawsuit has been initiated against Capricor Therapeutics, Inc. (CAPR) in response to claims that the company’s stock was sold at inflated prices. Filed by the law firm Levi & Korsinsky on July 17, 2025, the lawsuit alleges that shareholders purchased stock during a defined class period from October 9, 2024, to July 10, 2025, without full knowledge of the company’s actual financial condition. Affected investors are being encouraged to seek information on participation in the action.
Capricor Therapeutics is engaged in the development of innovative cell and exosome-based therapies aimed at treating muscular and select other diseases. The focus of the lawsuit is the company’s lead drug candidate, deramiocel, which is under investigation for its potential to address cardiomyopathy related to Duchenne muscular dystrophy (DMD).
Central to the allegations are claims that Capricor and certain senior executives made misleading public statements during the class period regarding the company’s progress toward obtaining a Biologics License Application (BLA) from the U.S. Food and Drug Administration (FDA). The lawsuit contends that essential safety and efficacy data from the Phase 2 HOPE-2 trial of deramiocel were not disclosed in official filings.
On November 13, 2024, Capricor announced that, following an FDA pre-BLA meeting, it began a rolling submission for full approval of deramiocel, expecting to finalize the process by year’s end. During an earnings call that same day, the CEO claimed that clinical trial data demonstrated significant benefits of deramiocel in treating both skeletal muscle myopathy and cardiomyopathy, conditions that can greatly hinder muscle function and heart performance, respectively.
Furthering their defense, Capricor reported on March 19, 2025, that its BLA submission included promising data about deramiocel’s safety and effectiveness, suggesting improvements in cardiac function lasting up to three years. However, subsequent developments reportedly contradicted these positive claims.
The lawsuit asserts that the company, through its executives, failed to disclose critical information regarding the results of the four-year safety and efficacy trial. Investors allege they were misled about the effectiveness of the drug, particularly in light of regulatory requirements that Capricor did not meet.
This issue came to light on July 11, 2025, when Capricor announced it had received a Complete Response Letter (CRL) from the FDA, signaling a rejection of the BLA due to insufficient evidence of deramiocel’s effectiveness. Following this revelation, Capricor’s stock plummeted nearly 33% in a single day.
Finishing this tumultuous year, Capricor’s stock has reportedly fallen by 54.5%. The lawsuit underscores the importance of accurate information for investors, who are seeking redress for their losses amid claims of misleading disclosures from the company.
This article was automatically written by Open AI, and the people, facts, circumstances, and story may be inaccurate. Any article can be requested for removal, retraction, or correction by emailing contact@publiclawlibrary.org.