#DAY ONE BIOPHARMACEUTICALS FULL#
#DAY ONE BIOPHARMACEUTICALS TRIAL#

Day One is conducting a pivotal Phase 3 clinical trial (FIREFLY-2/LOGGIC) evaluating tovorafenib as a front-line therapy for patients newly diagnosed with pLGG.Additional interim results from FIREFLY-1 will be presented at the Society for Neuro-Oncology (SNO) annual meeting in November 2022.Pivotal FIREFLY-1 trial of tovorafenib in relapsed or progressive pLGG in patients harboring activating RAF alterations continues to progress following positive initial data from the first 25 patients announced in June 2022.2023 is poised to be another pivotal year for Day One.”

#DAY ONE BIOPHARMACEUTICALS FULL#

We look forward to the topline results from the full FIREFLY-1 pivotal study population, expected in the first quarter of 2023, and potential subsequent NDA submission to the FDA. “With this significant momentum, we believe we are well-positioned to continue to execute on our mission. We announced positive interim results from our pivotal FIREFLY-1 study with tovorafenib in relapsed or progressive pLGG in patients harboring activating RAF alterations, completed a follow-on public offering, advanced our pivotal Phase 3 FIREFLY-2/LOGGIC trial for frontline pLGG as well as our Phase 2 FIRELIGHT-1 trial for MAPK-altered solid tumors, and recently entered into a CRADA agreement with the NCI to further expand therapeutic research opportunities using tovorafenib,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “Day One’s progress in 2022 has been remarkable. 07, 2022 (GLOBE NEWSWIRE) - Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced financial results for the third quarter of 2022 and highlighted recent corporate achievements.

Strengthened leadership team with key appointments to senior management team and board of directors Topline results for full pivotal FIREFLY-1 study population with tovorafenib (DAY101) in relapsed or progressive pediatric low-grade glioma (pLGG) are expected in the first quarter of 2023

Day one biopharmaceuticals