SpringWorks Therapeutics Q1 2023 Earnings Report
Key Takeaways
SpringWorks Therapeutics reported its Q1 2023 financial results, highlighting the FDA's acceptance of the NDA for nirogacestat with Priority Review and the publication of the Phase 3 DeFi trial in the New England Journal of Medicine. The company is preparing for the potential launch of nirogacestat and advancing its pipeline, including the Phase 2b ReNeu trial for mirdametinib.
FDA accepted the New Drug Application for nirogacestat in desmoid tumors with Priority Review, setting a PDUFA action date for August 27, 2023.
Phase 3 DeFi trial data of nirogacestat in adults with desmoid tumors was published in the New England Journal of Medicine.
Topline data from the Phase 2b ReNeu trial evaluating mirdametinib in NF1-PN expected in the second half of 2023, with potential NDA submission in the first half of 2024.
Presented updated clinical data on MAPK solid tumor programs at the American Association for Cancer Research Annual Meeting 2023.