Shares of biopharmaceutical company Day One Biopharmaceuticals (NASDAQ:DAWN) are on the up move today after it announced data from a phase 2 study evaluating its investigational candidate tovorafenib (DAY-101). Additionally, the company has also initiated a rolling new drug application (NDA) for DAY-101 with the U.S. Food and Drug Administration (FDA) as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG).
The rolling submission allows the company to submit parts of the application and have them reviewed on an ongoing basis. The submission is expected to be completed in October 2023.
In the Phase 2 study, DAY-101 was observed to be well-tolerated with clinically meaningful responses in subjects. Further, the therapy demonstrated an overall response rate of 67% with a clinical benefit rate of 93%.
DAY-101 has already received breakthrough therapy and rare pediatric disease designation in the U.S. alongside an orphan drug designation in the U.S. as well as Europe.
Overall, the Street has a $37 consensus price target on DAWN alongside a Moderate Buy consensus rating. Today’s price gains come on top of a nearly 8.5% climb in DAWN shares over the past five sessions.
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