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DMD Community Eyes First Cell Therapy Approval Following FDA’s Acceptance of Deramiocel Submission

Summary by neurologylive.com
With a scheduled PDUFA date of August 31, 2025, deramiocel looks to become the first marketed treatment for cardiomyopathy in DMD, one of the leading causes of death in this patient population.
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neurologylive.comneurologylive.com

DMD Community Eyes First Cell Therapy Approval Following FDA’s Acceptance of Deramiocel Submission

With a scheduled PDUFA date of August 31, 2025, deramiocel looks to become the first marketed treatment for cardiomyopathy in DMD, one of the leading causes of death in this patient population.

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CureDuchenneCureDuchenne

Capricor announces the FDA will decide on approval of their experimental cell therapy in August 2025

CureDuchenne provided early funding to Capricor Therapeutics, and we are pleased to share that the FDA has accepted its Biologics Licenses Application (BLA) seeking approval for Deramiocel to treat cardiomyopathy in Duchenne.  The FDA also granted Priority Review of this cell and exosome-based experimental therapeutic, with a target decision date of August 31, 2025. Link to press release:  https://www.capricor.com/investors/news-events/press-rel…

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CureDuchenne broke the news in on Tuesday, March 4, 2025.
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