Day One: Positive Trial Data, Rolling NDA Submission to FDA for Pediatric Low-Grade Glioma

 Overall response rate (ORR) of 67% and clinical benefit rate (CBR) of 93% in 69 heavily pretreated RANO-HGG evaluable patients

The Company expects to complete rolling NDA submission in October 2023

Conference call and webcast today at 6:00 p.m. CT

Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical Company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced new data from the registrational Phase 2 FIREFLY-1 trial evaluating the investigational agent tovorafenib (DAY101). These data were shared in an oral presentation today at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. In addition, the Company announced that it has initiated a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG).

Day One will host a conference call and webcast on June 4, 2023, at 6:00 p.m. CT. Participants can access the conference call live via webcast from the Investors & Media page of Day One’s website. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode that can be used to access the call.

The webcast will be made available for replay on the Company’s website after the event and will be available for 30 days following the live presentation.

https://finance.yahoo.com/news/day-one-announces-firefly-1-164500760.html