Immunome reported Phase III data showing its investigational oral therapy reduced the risk of disease worsening or death by 84% versus placebo in progressing desmoid tumors. The company described the result as a robust primary endpoint success and plans an NDA submission to the U.S. Food and Drug Administration next year. The Phase III readout positions Immunome’s oral agent as a potential first approved systemic option for this rare, locally aggressive soft-tissue tumor. Desmoid tumors are often managed with surgery, radiation, or off-label systemic agents; a clear, positive randomized Phase III signal gives Immunome a direct regulatory pathway. If approved, the drug could alter standards of care for desmoid tumors and open a commercial opportunity in an orphan indication. Companies developing therapies for rare tumors often rely on single pivotal trials for approval; the scale of the effect here supports expedited regulatory engagement.