Capricor Therapeutics Announces The FDA Has Scheduled Pre-BLA Meeting With The Company For The Treatment Of Duchenne Muscular Dystrophy
Portfolio Pulse from Benzinga Newsdesk
Capricor Therapeutics (NASDAQ:CAPR) announced that the FDA has scheduled a Pre-BLA meeting with the company in Q3 2024 for its treatment of Duchenne Muscular Dystrophy, deramiocel (CAP-1002). The meeting aims to finalize BLA filing plans and outline the rolling BLA submission timeline.
June 25, 2024 | 12:37 pm
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Capricor Therapeutics announced a scheduled Pre-BLA meeting with the FDA in Q3 2024 for its Duchenne Muscular Dystrophy treatment, deramiocel (CAP-1002). This is a significant step towards finalizing BLA filing plans and could positively impact the stock.
The scheduled Pre-BLA meeting with the FDA is a critical regulatory milestone for Capricor Therapeutics. Successfully finalizing BLA filing plans and outlining the rolling BLA submission timeline could lead to market approval, which would be a significant positive catalyst for the stock.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100