Policy & Regulation
Immunome submits FDA application for varegacestat following strong Phase 3 results
29 April 2026 -

Biotechnology company Immunome Inc (Nasdaq:IMNM) disclosed on Wednesday that it has submitted a New Drug Application to the U.S. Food and Drug Administration for varegacestat, an oral gamma secretase inhibitor for the treatment of adults with desmoid tumors, supported by positive results from the Phase 3 RINGSIDE trial.

This study demonstrated a statistically significant improvement in progression-free survival compared with placebo, reducing the risk of disease progression or death by 84% (hazard ratio 0.16; p

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