Company: DAWN
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0000950170-25-064436
Chunk: 10

Company: Day One Biopharmaceuticals, Inc.
Filing Date: 2025-05-06
Form: 10-Q
Item: Item 2
Chunk 10
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 2021. Additionally, the FDA granted rare pediatric disease designation to tovorafenib for treatment of low-grade gliomas, or LGGs, harboring an activating RAF alteration in July 2021.

On April 23, 2024, we announced that the FDA approved OJEMDA™ (tovorafenib) for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. The indication was approved under accelerated approval based on response rate and duration of response. With the approval, we received a rare