Day One Biopharamceuticals Reports Initial Data
Jun 13, 2022 By MarketDepth
Day One Biopharmaceuticals (Nasdaq: DAWN) today announced positive initial data from pivotal FIREFLY-1 trial of Tovorafenib.
Shares of Day One Biopharmaceuticals (Nasdaq: DAWN) opened 125% higher than the company’s previous close.
Beneficial Rate Over 91%
Tovorafenib is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway. Initial data showed an overall response rate of 64% and clinical benefit rate of 91% in the first 22 evaluable patients, and topline results from the full FIREFLY-1 trial population expected in Q1 2023.
“These initial findings underscore the potential of tovorafenib monotherapy to become a significant and transformative new option for relapsed/progressive pLGG, a pediatric brain tumor with no approved treatments today. With the registrational cohort fully enrolled, patient follow-up is ongoing, and we look forward to the topline data from the complete study population in the first quarter of 2023. Based on these positive initial data, we plan to begin the pivotal Phase 3 FIREFLY-2 clinical trial evaluating tovorafenib as a front-line therapy in pLGG to evaluate whether tovorafenib can provide benefit early in the disease development.”Samuel Blackman, M.D., Ph.D., co-founder and chief medical officer of Day One
The company now plans to present additional interim trial results from FIREFLY-1 at an upcoming medical conference in the second half of 2022, and will submit a new drug application (NDA) to the United States Food and Drug Administration (FDA) in the first half of 2023, should the data be supportive.