SpringWorks Therapeutics Receives Positive CHMP Opinion for Mirdametinib, European Commission Decision Expected in Q3 2025

Reuters
23 May
SpringWorks <a href="https://laohu8.com/S/LENZ">Therapeutics</a> 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.

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