Immunome advances cancer drug with 84% risk reduction

• The United States Food and Drug Administration accepted a New Drug Application for Immunome's tumor candidate varegacestat.
• Pivotal Phase 3 trial data demonstrated an 84% reduction in the risk of disease progression or death.
• Federal regulators assigned a definitive Prescription Drug User Fee Act target action date of April 28, 2027.

The United States Food and Drug Administration accepted a New Drug Application from Immunome (NASDAQ:IMNM) for its oral tumor treatment varegacestat following clinical trial data showing an 84% reduction in disease progression risk.

The regulatory milestone advances the investigational therapy toward a critical federal action date after preliminary Phase 3 trial statistics were officially introduced at the 2026 American Society of Clinical Oncology Annual Meeting.

“The FDA’s acceptance of our NDA for varegacestat is an important milestone for Immunome and for patients living with desmoid tumors,” said Immunome President and Chief Executive Officer Clay Siegall.

The clinical profile recorded manageable adverse events across the treatment group, led predominantly by low-grade instances of diarrhea at 82% and fatigue at 44%.

The development pipeline focuses heavily on securing market authorizations for first-in-class and best-in-class targeted oncology platforms to provide alternative oral treatment choices for adult patients.

Health authorities assigned a definitive Prescription Drug User Fee Act target action date of April 28, 2027, to finalize the formal therapeutic review process.