Investigation Launched Against Capricor Therapeutics Over Deramiocel BLA Denial
Lawsuit Reminder for Capricor Investors: Deadline for Lead Plaintiff is September 15, 2025, as per Faruqi & Faruqi's Announcement - CAPR
Capricor Therapeutics, Inc. is currently under investigation for potential violations of federal securities laws following the denial of its Biologics License Application (BLA) for deramiocel by the U.S. Food and Drug Administration (FDA).
The FDA's Complete Response Letter (CRL), issued on July 11, 2025, stated that deramiocel did not meet the statutory requirement for substantial evidence of effectiveness and the need for additional clinical data. The CRL also referenced outstanding items in the Chemistry, Manufacturing, and Controls section of the application.
The investigation alleges that Capricor and its executives provided false and/or misleading statements about Capricor's ability to obtain a BLA for deramiocel. Additionally, it is alleged that Capricor concealed material adverse facts concerning its four-year safety and efficacy data from its Phase 2 HOPE-2 trial study of deramiocel.
Any investor who purchased or acquired securities in Capricor between October 9, 2024, and July 10, 2025, is encouraged to contact Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310) for more information.
The investigation concerns Capricor's lead cell therapy candidate drug deramiocel for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). Faruqi & Faruqi, LLP is a leading national securities law firm, and the law firm responsible for this advertisement.
Faruqi & Faruqi, LLP is investigating potential claims against Capricor Therapeutics, Inc., and anyone with information regarding Capricor's conduct is encouraged to contact the firm. The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice.
For updates on this investigation, follow Faruqi & Faruqi, LLP on LinkedIn, X, or Facebook. If a nationwide shareholder derivative lawsuit against Capricor Therapeutics, Inc. is filed timely, the name of the shareholder serving as lead plaintiff will not be publicly available.
A photo accompanying this announcement is available at this link.
Investors who purchased or acquired securities in Capricor Therapeutics, Inc. are advised to stay informed about this ongoing investigation. For more information, visit Faruqi & Faruqi's website or contact Faruqi & Faruqi, LLP directly.
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