Overview

A class action lawsuit has been filed against Capricor Therapeutics, Inc. (“Capricor” or the “Company”) and certain of the Company’s former senior executive officers alleging violations of the federal securities laws. Capricor’s common stock traded on the NASDAQ Stock Market (the “NASDAQ”) under the ticker symbol “CAPR.”

The Capricor class action lawsuit was brought on behalf of all persons and entities who purchased or otherwise acquired Capricor securities between October 9, 2024, and July 10, 2025, both dates inclusive (the “Class Period”).

Capricor is a clinical-stage biotechnology company that engages in the development of transformative cell and exosome-based therapeutics for treating Duchenne muscular dystrophy (DMD) and other diseases with unmet medical needs in the United States. Its lead product candidate is deramiocel, an allogeneic cardiosphere-derived cells.

The lawsuit alleges that Defendants, throughout the class period, provided investors with material information concerning Capricor’s lead cell therapy candidate, deramiocel, for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). These 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). At the same time, however, Defendants allegedly disseminated false and misleading statements and/or concealed material adverse facts regarding deramiocel’s four-year safety and efficacy data from the Phase 2 HOPE-2 trial. As a result, Plaintiffs and other investors purchased Capricor securities at artificially inflated prices.

On May 5, 2025, Capricor announced that the FDA had completed its mid-cycle review of the BLA for deramiocel. According to the Company, no significant deficiencies were identified and the application remained on track for a PDUFA decision by August 31, 2025. Capricor also stated the FDA intended to convene an advisory committee meeting. Despite this announcement, the Company’s stock dropped from $10.30 to $7.30 per share, reflecting market uncertainty.

In the following weeks, the stock rebounded, supported by further assurances from Capricor regarding the strength of its BLA and clinical data. However, on June 20, 2025, Stat News reported that the FDA had canceled the advisory committee meeting, citing skepticism over deramiocel’s efficacy and safety. Capricor’s stock fell sharply from $11.94 to $8.26 per share. Then, on July 11, 2025, Capricor disclosed it had received a Complete Response Letter (CRL) from the FDA, denying the BLA due to insufficient evidence of effectiveness and outstanding issues related to Chemistry, Manufacturing, and Controls (CMC). The Company’s stock dropped again—from $11.40 to $7.64 per share—leaving investors to absorb significant losses tied to the alleged misrepresentations.

*          *          *

If you purchased or otherwise acquired Capricor securities between October 9, 2024, and July 10, 2025, both dates inclusive, and you wish to serve as lead plaintiff in this lawsuit, we encourage you to submit your information to DiCello Levitt LLP via the form on this page. 

You can also contact DiCello Levitt partner Brian O’Mara by calling (888) 287-9005 or at investors@dicellolevitt.com. 

The deadline to apply to the Court to serve as lead plaintiff in the Capricor class action lawsuit is September 15, 2025.