03:54 PM EDT, 04/23/2024 (MT Newswires) -- Day One Biopharmaceuticals ( DAWN ) shares rose 10% in recent Tuesday trading after the company's Ojemda received accelerated approval from the US Food and Drug Administration for the treatment of patients six months and older with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.

The FDA said it is the first systematic therapy approved for treating pediatric low-grade glioma with BRAF rearrangements, including fusions.

The approval was based on the overall response rate and duration of response in an open-label, single-arm trial, the FDA said Tuesday in a statement.

Continued approval of the drug is subject to verification of clinical benefit in confirmatory trials, the FDA said.

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