Capricor to File Application for Full Approval of Deramiocel for Duchenne Cardiomyopathy

 BLA to be Supported by Existing and Natural History Cardiac Data as Discussed with the FDA-

-Initial Label Would Include All Patients with Cardiomyopathy Associated with Duchenne Muscular Dystrophy-

-Rolling Submission Planned to Commence in October 2024-

-Internal GMP Manufacturing Established to Support BLA and Commercialization-

-Investor Webcast Today at 8:30 a.m. ET-

Capricor will host a conference call and webcast at 8:30 a.m. ET today to discuss these updates. To participate in the conference call, please dial 1-800-717-1738 (domestic/toll-free) or 1-646-307-1865 (international) and reference the conference ID: 62574. Participants can use guest dial-in numbers above and be answered by an operator or click here for instant telephone access. To participate via webcast, please click here to view the slides. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company’s website.

https://www.globenewswire.com/news-release/2024/09/24/2952130/0/en/Capricor-Therapeutics-Announces-Intent-to-File-Biologics-License-Application-for-Full-Approval-of-Deramiocel-for-the-Treatment-of-Duchenne-Muscular-Dystrophy-Cardiomyopathy.html