Investors skeptical as Phase III readout points SpringWorks toward first submission

Five years after SpringWorks’ spinout from Pfizer, the company is preparing its first regulatory submission based on a Phase III readout in desmoid tumors. Investors appear concerned, however, about the treatment’s safety profile ahead of its entry into a market in which other systemic therapies are used off-label.

SpringWorks Therapeutics Inc. (NASDAQ:SWTX) said Tuesday that nirogacestat met the primary endpoint evaluating progression-free survival in the Phase III DeFi trial. The γ secretase inhibitor reduced the risk of disease progression by 71% (HR=0.29; 95% CI: 0.15, 0.55; p <0.001), setting up a planned NDA submission to FDA next half...