Capricor Therapeutics Announces Type-B Meeting With FDA For CAP-1002 Program For Duchenne Muscular Dystrophy, FDA Feedback Supports Requests For Pre-BLA Meeting And Subsequent Rolling BLA Submission Following Upcoming Q2 Type-B FDA Meeting
Portfolio Pulse from Benzinga Newsdesk
Capricor Therapeutics announced a Type-B meeting with the FDA regarding its CAP-1002 program for Duchenne Muscular Dystrophy. The FDA's feedback supports the company's requests for a pre-BLA meeting and a subsequent rolling BLA submission following an upcoming Q2 Type-B FDA meeting.
April 24, 2024 | 1:04 pm
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POSITIVE IMPACT
Capricor Therapeutics is moving forward with FDA discussions on its CAP-1002 treatment for Duchenne Muscular Dystrophy, receiving supportive feedback for its regulatory submission strategy.
The positive feedback from the FDA regarding Capricor's CAP-1002 program for Duchenne Muscular Dystrophy is a significant step forward in the drug's development and regulatory approval process. This development is likely to be viewed positively by investors, as it indicates progress towards potential market approval. The FDA's support for the company's pre-BLA meeting and rolling BLA submission strategy increases the likelihood of a streamlined review process, potentially accelerating the drug's time to market.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100