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.
免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。