Regeneron Pharmaceuticals Says Linvoseltamab BLA For Treatment Of Relapsed/Refractory Multiple Myeloma Accepted For FDA Priority Review, Target Action Date For FDA Decision Is August 22, 2024
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Regeneron Pharmaceuticals announced that its Biologics License Application (BLA) for Linvoseltamab, aimed at treating relapsed/refractory multiple myeloma, has been accepted for FDA Priority Review. The target action date for the FDA's decision is August 22, 2024.
February 21, 2024 | 12:16 pm
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Regeneron Pharmaceuticals' BLA for Linvoseltamab has been accepted for FDA Priority Review, with a decision expected by August 22, 2024.
The acceptance of Regeneron's BLA for Linvoseltamab by the FDA for Priority Review is a significant positive development. It not only validates the potential of Linvoseltamab as a treatment for relapsed/refractory multiple myeloma but also positions Regeneron favorably in the biotech and pharmaceutical market. The Priority Review status accelerates the review process, indicating a strong interest from the regulatory body in bringing this treatment to market swiftly, assuming it meets all efficacy and safety criteria. This news is likely to be viewed positively by investors, as it represents progress in Regeneron's pipeline and potential for future revenue growth.
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