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EMA Validates Immunome's Marketing Application for Varegacestat in Desmoid tumors

By BORSA NewsroomPublished Oct 30, 2026, 7:30 AM EDTUpdated Oct 30, 2026, 7:30 AM EDT

The European Medicines Agency has accepted Immunome's marketing application for Varegacestat, an oral drug for Desmoid tumors, triggering a formal review. The filing is backed by Phase 3 data showing an 84% reduction in progression risk and a 56% response rate, with a US FDA decision expected by April 2027.

Sentimentbullish 80

Strongly bullish · 80 of 100

Impact50

low · stays off the top drivers

Confidence95%

high confidence · 2 wires

Eventdeveloping

v2 · alerted to followers

WHAT WE KNOW

EMA validated Immunome's MAA for Varegacestat for Desmoid tumors.