SpringWorks Therapeutics Announces European Medicines Agency Validation for Marketing Authorization Application of Nirogacestat for the Treatment of Adults with Desmoid Tumors
STAMFORD, Conn., Feb. 29, 2024 (GLOBE NEWSWIRE) — SpringWorks Therapeutics, Inc. (Nasdaq:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for nirogacestat, an oral gamma secretase inhibitor, for the treatment of adults with desmoid tumors. If approved, nirogacestat will be the first therapy to receive marketing authorization in the European Union (EU) for the treatment of desmoid tumors. Nirogacestat previously received Orphan Drug designation from the European Commission for the treatment of soft tissue sarcoma.