SpringWorks Therapeutics Q2 2023 Earnings Report
Key Takeaways
SpringWorks Therapeutics reported a net loss of $77.9 million for the second quarter of 2023. The company is preparing for the potential FDA approval of nirogacestat and anticipates topline data from the ReNeu trial in the fourth quarter.
Presented additional Phase 3 DeFi data at ASCO, demonstrating clinically significant reductions in pain and substantial reductions in tumor volume and T2 hyperintensity with nirogacestat treatment.
Completed enrollment of Phase 2 trial evaluating nirogacestat in patients with ovarian granulosa cell tumors.
Highlighted encouraging Phase 1 and 2 clinical data from emerging pipeline programs at AACR and EHA.
FDA updated the PDUFA action date for the NDA for nirogacestat to November 27, 2023.
SpringWorks Therapeutics
SpringWorks Therapeutics
Forward Guidance
SpringWorks expects to present topline data from the pediatric and adult cohorts of the Phase 2b ReNeu trial evaluating mirdametinib in NF1-associated plexiform neurofibromas (NF1-PN) in the fourth quarter of 2023. SpringWorks expects to file an Investigational New Drug Application for SW-682 in the fourth quarter of 2023.