Capricor Investors: Class Action Lawsuit Filed Over Misleading Statements and Concealed Facts.

Capricor Therapeutics investors have until September 15, 2025, to request lead plaintiff appointment. The class action lawsuit alleges that the company provided misleading statements about its lead cell therapy candidate drug deramiocel, and received a Complete Response Letter from the FDA denying the BLA, citing failure to meet effectiveness requirements and need for additional clinical data. The lawsuit seeks damages for investors who suffered losses during the Class Period of October 9, 2024, through July 10, 2025.

Title: Capricor Therapeutics Investors Urged to Act on Class Action Lawsuit Deadline

July 2, 2025 - Capricor Therapeutics, Inc. investors have until September 15, 2025, to request lead plaintiff appointment in a class action lawsuit. The lawsuit alleges that the company provided misleading statements about its lead cell therapy candidate drug deramiocel, which ultimately led to a significant decline in stock price.

The class action lawsuit, filed on August 20, 2025, by the law firm Faruqi & Faruqi, LLP, alleges that Capricor Therapeutics made false and misleading statements and failed to disclose material information concerning its lead cell therapy candidate drug, deramiocel. The drug was being developed for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD).

The complaint specifically alleges that Capricor provided investors with materially false and misleading information regarding its ability to obtain a Biologics License Application (BLA) from the U.S. Food and Drug Administration (FDA) for deramiocel. Additionally, the firm alleges that Capricor concealed material adverse facts concerning the safety and efficacy data from its Phase 2 HOPE-2 trial study of deramiocel [1].

On July 11, 2025, Capricor issued a press release announcing that it received a Complete Response Letter (CRL) from the FDA denying the BLA. The FDA cited insufficient evidence of effectiveness and the need for additional clinical data. This news led to a significant decline in the price of Capricor stock, from $11.40 per share on July 10, 2025, to $7.64 per share on July 11, 2025 [1].

Investors who suffered losses exceeding $50,000 during the relevant time frame are encouraged to contact the law firm Faruqi & Faruqi, LLP, directly at 877-247-4292 or 212-983-9330 (Ext. 1310) [1]. The firm has until September 15, 2025, to seek the role of lead plaintiff in the federal securities class action.

Additional law firms have also notified investors about the class action lawsuit, including Levi & Korsinsky, LLP, and Bronstein, Gewirtz & Grossman, LLC. These firms have also set September 15, 2025, as the deadline to request the appointment of a lead plaintiff [2][3].

Investors who believe they may be eligible for the class action should visit the respective law firms' websites or contact the firms directly for more information. Participation in the class action does not require investors to serve as lead plaintiffs, and there are no out-of-pocket costs or fees for participating.

References:
[1] https://www.globenewswire.com/news-release/2025/08/20/3136547/0/en/CAPR-Investors-Have-the-Opportunity-to-Lead-the-Capricor-Therapeutics-Securities-Fraud-Lawsuit-with-Faruqi-Faruqi-LLP.html
[2] https://www.marketscreener.com/news/levi-korsinsky-notifies-capricor-therapeutics-inc-investors-of-a-class-action-lawsuit-and-upcomi-ce7c50dad18ef325
[3] https://www.globenewswire.com/news-release/2025/08/21/3137516/9788/en/CAPR-INVESTOR-ALERT-Bronstein-Gewirtz-Grossman-LLC-Announces-that-Capricor-Therapeutics-Inc-Investors-with-Substantial-Losses-Have-Opportunity-to-Lead-Class-Action-Lawsuit.html