Immunome reported positive topline Phase 3 results for its oral gamma‑secretase inhibitor (varegacestat), showing an 84% reduction in the risk of progression or death in patients with progressing desmoid tumors. The company said it plans to submit a New Drug Application (NDA) to the U.S. FDA by the second quarter of next year. The trial met its primary endpoint with statistically significant and clinically meaningful improvement in progression‑free survival versus placebo; the result follows the recent regulatory and commercial success of other gamma‑secretase inhibitors in desmoid tumors. Immunome’s leadership called the outcome a clear path to registration and commercialization. The win positions Immunome to challenge incumbents and to commercialize an oral option for a rare, often debilitating tumor; regulators and payers will scrutinize long‑term safety and comparative benefit as the NDA is readied.