Immunome reported decisive Phase III results showing its oral gamma‑secretase inhibitor reduced the risk of disease progression or death by 84% in patients with progressing desmoid tumors. The trial met its primary endpoint with statistically significant and clinically meaningful improvements in progression‑free survival, prompting Immunome to plan an NDA submission to the U.S. FDA in the coming year. The readout positions Varegacestat as a potential first or best‑in‑class oral option for a rare, treatment‑resistant soft‑tissue tumor and follows regulatory precedent set by earlier approvals in the same mechanism class. Immunome’s management signaled they will move quickly to convert the data into a filing and seek label approval for the desmoid indication. Investors and potential partners will watch the full dataset for durability, safety, and biomarker subgroup performance that could influence market positioning and reimbursement strategy. The company’s next steps are regulatory engagement and preparing manufacturing and commercialization planning ahead of an expected 2026 submission.