Biotechnology company Immunome Inc (Nasdaq:IMNM) announced on Friday that the European Medicines Agency (EMA) has validated its Marketing Authorization Application for varegacestat, an investigational oral, once-daily gamma secretase inhibitor for adults with desmoid tumors.

Validation confirms the application is complete and allows the EMA to begin its review under the centralized authorization procedure.

The application is supported by positive results from the Phase 3 RINGSIDE trial, which demonstrated a statistically significant 84% reduction in the risk of disease progression or death compared with placebo. The study also achieved all key secondary endpoints, including an objective response rate of 56%, versus 9% for placebo, and improvements in worst pain intensity.

An exploratory analysis showed a median best change in tumour volume of -83% with varegacestat, compared with an 11% increase in the placebo group. The treatment was generally well tolerated, with a manageable safety profile; most reported adverse events were mild to moderate.

The EMA validation follows the US Food and Drug Administration's acceptance of Immunome's New Drug Application for varegacestat. If approved in the European Union, varegacestat could offer adults with desmoid tumors a new oral treatment option.