Capricor Therapeutics, Inc. Long-Term Shareholder Announcement: Johnson Fistel Encourages Investors to Reach Out For More Information About Continuing Investigation

Johnson Fistel, PLLP is investigating potential legal claims on behalf of Capricor Therapeutics, Inc. (NASDAQ: CAPR) shareholders, concerning alleged misconduct by certain officers and directors that may have harmed the company and its investors.

Investors who have continuously held Capricor shares since before October 9, 2024, may have legal rights and are encouraged to contact the firm to learn more:

On July 11, 2025, Capricor announced it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) denying the Company’s Biologics License Application (BLA) for its lead cell therapy candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD). The FDA cited that the evidence submitted did not meet the statutory requirement for substantial evidence of effectiveness and pointed to deficiencies in the Chemistry, Manufacturing, and Controls (CMC) portion of the application. Following this news, Capricor’s share price fell sharply, dropping from approximately $11.40 on July 10, 2025, to around $7.64 on July 11, 2025, causing significant losses to investors.

A previously filed shareholder class action complaint alleges that, throughout the Class Period, Capricor and certain executives made materially false and/or misleading statements and failed to disclose material adverse facts about the Company’s business and operations. In particular, the complaint alleges that Capricor misrepresented deramiocel’s progress toward FDA approval and concealed concerns regarding four-year safety and efficacy data from the Phase 2 HOPE-2 trial. The complaint further claims that the Company overstated the likelihood of regulatory approval and the strength of its clinical results while downplaying significant regulatory and manufacturing challenges.

You may be able to pursue changes to the company’s corporate governance practices, seek the recovery of funds for the company, and request a court-approved incentive award, all at no cost to you. Please contact Johnson Fistel at (619) 814-4471 to learn more.