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Stock impact report

Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy

Capricor Therapeutics, Inc. (CAPR) 
Last capricor therapeutics, inc. earnings: 3/18 04:01 pm Check Earnings Report
US:NASDAQ Investor Relations: capricor.com/investors
Company Research Source: GlobeNewswire
FDA has indicated that an Advisory Committee meeting is not required at this timeIn-person late-cycle review meeting scheduled for mid-July Biologics License Application (BLA) remains under Priority Review with PDUFA target action date of August 31, 2025Four-year data presented at PPMD 2025 Conference demonstrate sustained cardiac function SAN DIEGO, June 24, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today provided regulatory updates related to its Biologics License Application (BLA) for Deramiocel, the Company’s lead cell therapy candidate for the treatment of Duchenne Muscular Dystrophy (DMD)—associated cardiomyopathy. As part of the FDA’s ongoing review, the Company has been informed that an Advisory Committee meeting is not indicated at this time. The BLA remains under Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of A Show less Read more
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