Immunome announced positive Phase III data showing its oral gamma‑secretase inhibitor, varegacestat, reduced the risk of disease progression or death by 84% in patients with progressing desmoid tumors. The company reported statistically significant improvement in progression‑free survival versus placebo and said it will prepare an NDA submission to the U.S. FDA in 2026. The readout represents a rare late‑stage win for a small oncology player and follows prior approvals in the indication that established regulatory precedent for gamma‑secretase inhibitors. Investigators and company statements emphasized the magnitude of the effect on tumor control and the potential to offer the first oral therapy for a difficult, debilitating disease with few options. Clinical details released by Immunome cited the primary endpoint and key secondary measures; the company plans to use the Phase III dataset to support regulatory filings and commercialization planning. Analysts flagged potential commercial and development questions but noted the data create a clear path to an NDA and potential label if regulators concur.