Skip to main content
Signal8

Immunome Announces Submission of New Drug Application to U.S. FDA for Varegacestat for the Treatment of Adults with Desmoid Tumors

$IMNMPress releaseApr 29, 2026, 7:30 AM ETRead the release

Immunome submitted a New Drug Application to the FDA for varegacestat for the treatment of adults with desmoid tumors. The submission is supported by Phase 3 RINGSIDE data showing an 84% reduction in the risk of disease progression or death and an objective response rate of 56%.

Key figures

Drug Name
Varegacestat
Phase Of Trial
Phase 3
P value
<0.0001
Hazard ratio
0.16
Patients randomized
156
Median tumor volume reduction
-83%

AI analysis

The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.

AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.