Abeona Therapeutics Announces FDA Accepts and Grants Priority Review for Pz-cel Biologics License Application (BLA)
Portfolio Pulse from Benzinga Newsdesk
Abeona Therapeutics Inc. announced that the FDA has accepted and granted Priority Review for their BLA for pz-cel, a treatment for RDEB. The FDA set a PDUFA target action date of May 25, 2024, and indicated no Advisory Committee meeting is planned for the application.
November 27, 2023 | 12:32 pm
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Abeona Therapeutics' BLA for pz-cel has been accepted for Priority Review by the FDA, with a PDUFA target action date of May 25, 2024, which is a positive step for the company's investigational treatment for RDEB.
The acceptance of the BLA for Priority Review by the FDA is a significant positive development for Abeona Therapeutics, as it indicates a faster review process and a recognition of the treatment's potential importance. The lack of an Advisory Committee meeting suggests a smoother path forward, potentially reducing uncertainty and increasing investor confidence in the near term.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100