Immunome Submits FDA Application for Varegacestat in Desmoid Tumors
Event summary
- Immunome submitted a New Drug Application (NDA) to the FDA for varegacestat, an oral gamma secretase inhibitor, for treating adults with desmoid tumors.
- The NDA is supported by positive Phase 3 RINGSIDE trial results, showing an 84% reduction in disease progression risk vs. placebo.
- Varegacestat demonstrated a 56% objective response rate compared to 9% with placebo in the trial.
- The FDA submission follows topline data from December 2025 and upcoming ASCO presentation in May-June 2026.
The big picture
Immunome’s NDA submission for varegacestat marks a critical step in addressing desmoid tumors, a rare but debilitating condition with limited treatment options. The positive Phase 3 data positions varegacestat as a potential first-in-class therapy, though its success hinges on regulatory approval and market adoption. Immunome’s ability to leverage this milestone will be key amid broader trends in targeted oncology therapies.
What we're watching
- Regulatory Timeline
- The pace at which the FDA reviews varegacestat's NDA will determine its potential approval timeline.
- Commercial Viability
- Whether varegacestat can secure a competitive position in the desmoid tumor treatment market.
- Pipeline Progress
- How Immunome advances its broader oncology portfolio alongside varegacestat's development.
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