SpringWorks Therapeutics reports Q3 EPS ($1.27), consensus ($1.33)

Cash, cash equivalents and marketable securities were $422.4M as of September 30, 2023. “We continue to work closely with the FDA as they complete their review of our nirogacestat NDA and are ready to serve the desmoid tumor community following an approval,” said CEO Saqib Islam. “We are also on track to report topline data from our Phase 2b ReNeu trial of mirdametinib in patients with NF1-PN, which, if positive, would position us to file an NDA in the first half of 2024. Together, these anticipated milestones position us to have two medicines approved to treat patients with two distinct devastating diseases. In addition to these near-term events, we continue to advance our broader targeted oncology pipeline, which includes rare oncology, BCMA combinations in multiple myeloma, and biomarker-defined metastatic solid tumor programs, and look forward to providing further updates on our progress over the coming months.”