SpringWorks Therapeutics Receives Positive CHMP Opinion for Mirdametinib, European Commission Decision Expected in Q3 2025
SpringWorks Therapeutics Inc., a commercial-stage biopharmaceutical company, announced that the European Medicines Agency's Committee for Medicinal Products for Human Use $(CHMP)$ has given a positive opinion recommending conditional marketing authorization for their drug, mirdametinib. This MEK inhibitor is intended for the treatment of symptomatic, inoperable plexiform neurofibromas in pediatric and adult patients with neurofibromatosis type 1 (NF1). The European Commission is expected to make a final decision in the third quarter of 2025. If approved, mirdametinib will become the first and only therapy in the European Union authorized for both adults and children with NF1-PN.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. SpringWorks Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9457208-en) on May 23, 2025, and is solely responsible for the information contained therein.
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。