STAMFORD, Conn., June 20, 2025 - SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company, announced that the European Medicine Agency's $(EMA)$ Committee for Medicinal Products for Human Use $(CHMP)$ has adopted a positive opinion recommending the approval of nirogacestat. This oral gamma secretase inhibitor is proposed as a monotherapy for adults with progressing desmoid tumors requiring systemic treatment. If approved, nirogacestat will be the first and only therapy with marketing authorization in the EU for this condition. The European Commission is expected to make a final decision in the third quarter of 2025. The recommendation was based on the results from the Phase 3 DeFi trial, which demonstrated significant improvements in progression-free survival and patient-reported outcomes.
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