Day One Biopharmaceuticals Shares Rally on FDA Priority Review
30 Octubre 2023 - 8:54AM
Noticias Dow Jones
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)
Copyright (c) 2023 Dow Jones & Company, Inc.
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