Immunome Announces EMA Validation of Marketing Authorization Application for Varegacestat for the Treatment of Adults with Desmoid Tumors
Business Wire•30/10/2026•07:30 ET
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Key Highlights
- ➤EMA validates Immunome's MAA for varegacestat in adults with desmoid tumors
- ➤RINGSIDE cut progression or death risk 84% versus placebo (hazard ratio 0.16)
- ➤Varegacestat achieved 56% objective response rate versus 9% with placebo
- ➤FDA accepted varegacestat's NDA; PDUFA action date is April 28, 2027
Expert Statements
Clay Siegall, President and Chief Executive Officer of Immunome
“The EMA's validation of our MAA for varegacestat is an important step in our efforts to bring this treatment to patients with desmoid tumors globally”
Clay Siegall, President and Chief Executive Officer of Immunome
“The application is supported by the robust efficacy and safety data generated from the Phase 3 RINGSIDE trial”
Clay Siegall, President and Chief Executive Officer of Immunome
“There is a strong need for new treatment options for desmoid tumors, and we look forward to the potential to make varegacestat available to patients living with this challenging disease”
Immunome Announces EMA Validation of Marketing Authorization Application for Varegacestat for the Treatment of Adults with Desmoid Tumors
* The Marketing Authorization Application (MAA) is supported by positive Phase 3 RINGSIDE results demonstrating statistically significant improvements across the primary and all key secondary endpoints
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