Day One Biopharma Gets FDA Priority Review On NDA For Tovorafenib - Quick Facts

(RTTNews) - Day One Biopharmaceuticals (DAWN) announced the FDA accepted its New Drug Application for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma. The FDA has granted priority review and assigned a PDUFA target action date of April 30, 2024. The company noted that the FDA is not currently planning to hold an advisory committee meeting to discuss the application.

The NDA is based on results from the open-label, Phase 2 trial evaluating tovorafenib as a once-weekly monotherapy in patients aged 6 months to 25 years with relapsed or progressive pediatric low-grade glioma.

Shares of Day One Biopharmaceuticals are up 8% in pre-market trade on Monday.

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