Day One tovorafenib NDA filing completed sooner-than-expected, says Oppenheimer

After Day One Biopharmaceuticals announced it has completed submission of the rolling New Drug Application, or NDA, to the FDA for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma, or pLGG, Oppenheimer said this comes in about a month earlier than prior guidance for October. The firm, which thinks the company may have been able to file earlier because of an earlier maturation of treatment duration, does not believe the earlier submission “materially affects tovorafenib’s chances for approval,” which it still pegs at 50%. If approved, the firm believes the drug could sell about $200M a year at peak, which it sees implying that the “shares are fairly valued at these levels,” so it reiterates a Perform rating on the stock.