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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