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Tuesday, June 25, 2024

Capricor Pre-BLA Meeting with FDA for Deramiocel for Treatment of Duchenne

Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has scheduled a Pre-BLA (Biologics License Application) meeting with the Company in the third quarter of 2024 for deramiocel (CAP-1002), for the treatment of Duchenne Muscular Dystrophy (DMD). Capricor’s goal for this meeting will be to finalize its BLA filing plans based on all currently available data as well as to work with the FDA to outline the rolling BLA submission timeline.

https://www.globenewswire.com/news-release/2024/06/25/2903964/0/en/CORRECTION-Capricor-Therapeutics.html

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