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Sep 30, 2023
Day One Q3 2023 Earnings Report
Announced third quarter 2023 financial results and corporate progress.
Key Takeaways
Day One Biopharmaceuticals reported its third quarter 2023 financial results, highlighting the FDA's acceptance of the NDA for tovorafenib with Priority Review and a PDUFA target action date of April 30, 2024. The company's cash position remains strong, with sufficient resources to fund operations into 2026.
FDA accepted the NDA for tovorafenib with Priority Review and a PDUFA target action date of April 30, 2024.
Completed enrollment in the Phase 2a FIRELIGHT-1 substudy trial of tovorafenib as a monotherapy.
Patient enrollment continues in the Phase 1b/2 substudy (102b) of the FIRELIGHT-1 trial evaluating the combination of tovorafenib with pimasertib.
Cash, cash equivalents and short-term investments totaled $405.5 million on September 30, 2023.
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