Immunome says EMA validates MAA for varegacestat in desmoid tumors

Immunome says the European Medicines Agency has validated its marketing authorisation application for varegacestat, an investigational oral once-daily gamma secretase inhibitor, for adults with desmoid tumors. The company previously reported positive topline results from the Phase 3 RINGSIDE trial in December 2025 and has an ongoing US NDA review with a PDUFA target action date of April 28, 2027.

Detected & updated continuously · Source: Nebula