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Desmoid Tumor Drug Shows Promise
16 Dec, 2025
Summary
- Varegacestat reduced disease progression risk by 84%.
- Clinical trial met primary and secondary endpoints.
- New Drug Application planned for Q2 2026.
Shares of Immunome saw a significant increase following the announcement of positive clinical results for varegacestat, a treatment for desmoid tumors. This destructive disease affects 1,000 to 1,650 people annually in the U.S., causing debilitating physical and emotional distress.
The Phase 3 trial for varegacestat achieved its primary endpoint, demonstrating an 84% reduction in the risk of disease progression or death. All key secondary endpoints, including tumor volume and pain reduction, were also met. The drug was generally well-tolerated by participants.
Immunome intends to file a New Drug Application with the U.S. Food and Drug Administration in the second quarter of 2026. Based on these encouraging findings, varegacestat could potentially become the best-in-class, once-daily oral medicine for patients with desmoid tumors.
