FDA to hold an advisory committee meeting for Capricor’s deramiocel as part of marketing approval decision

CureDuchenne was an early funder of Capricor Therapeutics, which has announced completion of a mid-cycle review meeting with the U.S. FDA for their investigational cell therapy, deramiocel, for Duchenne cardiomyopathy. The company is on track for the PDUFA target action date of August 31, 2025, and the FDA has confirmed its intent to hold an advisory committee meeting before that date. We will continue to share information about that meeting as it becomes known.
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https://www.capricor.com/investors/news-events/press-releases/detail/311/capricor-therapeutics-announces-completion-of-mid-cycle