Immunome Says EMA Validates MAA For Varegacestat, Investigational, Oral, Once-Daily Gamma Secretase Inhibitor, For 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
• If approved, varegacestat could provide a meaningful new oral treatment option for adults with desmoid tumors in the European Union (EU)

Immunome, Inc. (NASDAQ:IMNM), a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies, today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for varegacestat, an investigational, oral, once-daily gamma secretase inhibitor (GSI), for the treatment of adults with desmoid tumors. Validation confirms that the application is complete, and the EMA will initiate review under the centralized marketing authorization procedure.