CRISPR Therapeutics Reports Completion Of FDA Advisory Committee Meeting for Exagamglogene Autotemcel (exa-cel) For Severe Sickle Cell Disease; PDUFA Target Action Date Is December 8, 2023
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CRISPR Therapeutics has completed an FDA Advisory Committee meeting for Exagamglogene Autotemcel (exa-cel) for severe Sickle Cell Disease. The PDUFA target action date is December 8, 2023. If approved, exa-cel could be the first genetic therapy available to approximately twenty thousand people with severe SCD in the U.S. The Biologics License Application for transfusion-dependent beta-thalassemia was assigned a PDUFA date of March 30, 2024.
October 31, 2023 | 9:56 pm
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CRISPR Therapeutics' exa-cel is under FDA review for severe Sickle Cell Disease. If approved, it could be a significant development for the company and the patients.
The news is directly related to CRISPR Therapeutics' product, exa-cel, which is under FDA review. If approved, it could be the first genetic therapy for severe Sickle Cell Disease in the U.S., which would likely have a positive impact on the company's stock in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100