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Home / Health / Desmoid Tumor Drug Shows Promise

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.
Desmoid Tumor Drug Shows Promise

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.

Disclaimer: This story has been auto-aggregated and auto-summarised by a computer program. This story has not been edited or created by the Feedzop team.
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The Phase 3 trial met its primary endpoint, showing an 84% reduction in the risk of disease progression or death for desmoid tumor patients.
Immunome plans to submit its New Drug Application to the FDA in the second quarter of 2026.
Between 1,000 and 1,650 people are diagnosed with desmoid tumors each year in the U.S.

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