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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-releases/detail/305/capricor-therapeutics-announces-fda-acceptance-and-priority