Capricor Therapeutics announced that the U.S. Food and Drug Administration has scheduled a Pre-BLA meeting with the Company in the third quarter of 2024 for deramiocel, for the treatment of Duchenne Muscular Dystrophy. 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.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on CAPR:
- Capricor Therapeutics Announces for the Treatment of Duchenne Muscular Dystrophy
- Capricor Therapeutics files $150M mixed securities shelf
- Capricor Therapeutics Announces Positive Type-B Meeting with FDA for CAP-1002 Program for Duchenne Muscular Dystrophy with an Aim to Expedite BLA Pathway
- Capricor Therapeutics completes Type B meeting with FDA for CAP-1002 program
- Capricor Therapeutics announces 3-year efficacy results from HOPE-2 OLE study
