Day One Biopharmaceuticals Shares Rally on FDA Priority Review

By Colin Kellaher

Day One Biopharmaceuticals shares rose sharply Monday after the clinical-stage biopharmaceutical company said the U.S. Food and Drug Administration granted priority review to its application seeking approval of its lead product candidate.

Shares of the Brisbane, Calif., company were recently changing hands at $11.49, up 13%.

Day One is seeking an FDA green light for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma, the most common brain tumor diagnosed in children.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

Day One said there is currently no standard of care and no approved therapy for the vast majority of pediatric low-grade glioma patients in the relapsed setting.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

October 30, 2023 10:39 ET (14:39 GMT)

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