The Gross Law Firm notifies investors that a class action has commenced in the United States District Court for the Southern District of California on behalf of shareholders of Capricor Therapeutics, Inc. who purchased securities between October 9, 2024 and July 10, 2025.
According to the complaint, defendants provided investors with material information concerning Capricor’s lead cell therapy candidate drug deramiocel for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). Defendants’ statements included, among other things, Capricor’s ability to obtain a Biologics License Application (BLA) for deramiocel from the U.S. Food and Drug Administration (FDA). Defendants provided these overwhelmingly positive statements to investors while, at the same time, disseminating false and misleading statements and/or concealing material adverse facts concerning its four-year safety and efficacy data from its Phase 2 HOPE-2 trial study of deramiocel. On July 11, 2025, Capricor issued a press release announcing it received a Complete Response Letter (CRL) from the FDA denying the BLA specifically citing it did not meet the statutory requirement for substantial evidence of effectiveness and the need for additional clinical data. Further, the CRL referenced outstanding items in the Chemistry, Manufacturing, and Controls section of the application. Following this news, the price of Capricor stock declined from $11.40 per share on July 10, 2025 to $7.64 per share on July 11, 2025.
If you wish to choose counsel to represent you and the class, you must apply to be appointed lead plaintiff and be selected by the Court. The lead plaintiff will direct the litigation and participate in important decisions including whether to accept a settlement for the class in the action. The lead plaintiff will be selected from among applicants claiming the largest loss from investment in the respective securities during the class periods. Members of the class will be represented by the lead plaintiff and counsel chosen by the lead plaintiff. No class has yet been certified in the above action. Appointment as Lead Plaintiff is not required to partake in any recovery.
Shareholders have until September 15, 2025 to request that the court appoint them lead plaintiff.
To receive more information, please fill out the form.
