NEW YORK, July 22, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Capricor Therapeutics, Inc. ("Capricor" or the "Company") (NASDAQ: CAPR) of a class action securities lawsuit.

CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Capricor investors who were adversely affected by alleged securities fraud between October 9, 2024 and July 10, 2025. Follow the link below to get more information and be contacted by a member of our team:

https://zlk.com/pslra-1/capricor-therapeutics-inc-lawsuit-submission-form-2?prid=157449&wire=4

CAPR investors may also contact Joseph E. Levi, Esq. via email at jlevi@levikorsinsky.com or by telephone at (212) 363-7500.

CASE DETAILS: 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.

WHAT'S NEXT? If you suffered a loss in Capricor during the relevant time frame, you have until September 15, 2025 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff.

NO COST TO YOU: If you are a class member, you may be entitled to compensation without payment of any out-of-pocket costs or fees. There is no cost or obligation to participate.

WHY LEVI & KORSINSKY: Over the past 20 years, the team at Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. Our firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States.

CONTACT:

Levi & Korsinsky, LLP

Joseph E. Levi, Esq.

Ed Korsinsky, Esq.

33 Whitehall Street, 17th Floor

New York, NY 10004

jlevi@levikorsinsky.com

Tel: (212) 363-7500

Fax: (212) 363-7171

www.zlk.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/capricor-therapeutics-inc-class-action-levi--korsinsky-reminds-capricor-investors-of-the-pending-class-action-lawsuit-with-a-lead-plaintiff-deadline-of-september-15-2025--capr-302509959.html

SOURCE Levi & Korsinsky, LLP