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Monday, September 30, 2024

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

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