Immunome reported positive topline results from a registrational Phase 3 trial showing its oral gamma‑secretase inhibitor (varegacestat) reduced risk of disease progression or death by 84% in patients with progressing desmoid tumors. The company said it will prepare a U.S. NDA submission targeted for mid‑next year based on the data. The Phase 3 readout comes after a long development run for desmoid tumors and follows earlier regulatory precedents for gamma‑secretase inhibitors in the indication. Immunome’s announcement included cohort and endpoint details that met the trial’s primary efficacy measure; company commentary emphasized statistical significance across secondary endpoints as well. Regulatory timing and labeling will now hinge on full data submission, safety analyses and discussions with the FDA. Clinicians and payers will watch tolerability and durability data closely because desmoid tumors can have variable natural histories and prior approvals in the space set high expectations for benefit‑risk clarity.