Approval for childhood brain tumor treatment
Day One Biopharmaceuticals (Nasdaq: DAWN) closed Tuesday’s trading 8% higher on positive regulatory news.
The company earlier announced that the US Food and Drug Administration (FDA) has approved Ojemda (tovorafenib), a type II RAF inhibitor, to treat patients aged six months and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
"Ojemda ushers in a new day for children living with relapsed or refractory pLGG"This indication is approved under accelerated approval based on response rate and duration of response. With the approval, Day One received a rare pediatric disease priority review voucher from the FDA.
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