Day One Gets FDA Rare-Pediatric Designation for Lead Candidate
July 27 2021 - 8:59AM
Dow Jones News
By Colin Kellaher
Day One Biopharmaceuticals Inc. on Tuesday said the U.S. Food
and Drug Administration granted rare-pediatric-disease designation
to DAY101, the company's lead product candidate, for the treatment
of brain tumors in children.
The South San Francisco, Calif., clinical-stage
biopharmaceutical company said the designation covers DAY101 in
low-grade gliomas harboring an activating RAF alteration.
Day One said there are currently no approved therapies or
standard of care for pediatric low-grade glioma, which, though
rare, is the most common brain tumor diagnosed in children.
The FDA's rare-pediatric-disease designation covers diseases
with serious or life-threatening manifestations that mainly affect
fewer than 200,000 people in the U.S. under the age of 18. The
agency awards priority-review vouchers to drugmakers upon approval
of drugs that are granted the designation, and those vouchers can
be used to obtain priority review for another drug or sold to other
companies.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
July 27, 2021 08:51 ET (12:51 GMT)
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