ARTICLE | Regulation
As priority review starts, Day One preps for shift to commercial phase
Five-year-old biotech receives April PDUFA date for pan-RAF inhibitor to treat slow-moving pediatric brain cancer
October 30, 2023 8:32 PM UTC
Less than five years after its formation, Day One is readying to launch tovorafenib as the first therapy for pediatric low-grade glioma, with an FDA approval decision now due in the spring.
FDA granted priority review to the pan-RAF inhibitor from Day One Biopharmaceuticals Inc. (NASDAQ:DAWN), setting up a short timeline to a PDUFA date of April 30, 2024. The biotech’s shares rose 17% on the news Monday, lifting its market cap above $1 billion...
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