Immunome is moving toward a potential 2027 launch of varegacestat after its Phase 3 RINGSIDE study produced a substantial reduction in the risk of disease progression or death in adults with progressing desmoid tumors. The program has now moved from late-stage clinical development into regulatory review in the U.S., while the company is preparing to pursue approval in Europe as well.
The Phase 3 RINGSIDE trial met its primary endpoint, with varegacestat demonstrating a statistically significant and clinically meaningful 84% reduction in the risk of disease progression or death compared with placebo. This corresponded to a hazard ratio of 0.16. Immunome also said the study demonstrated statistically significant improvements across the primary endpoint and all key secondary endpoints.
Detailed efficacy and safety findings from RINGSIDE were presented in an oral abstract session at the 2026 American Society of Clinical Oncology Annual Meeting. The presentation represented an important step for Immunome as it works to translate the Phase 3 results into potential regulatory approval and commercialization of varegacestat.
The regulatory process has already advanced in the U.S. In July 2026, the FDA accepted Immunome’s New Drug Application for varegacestat for the treatment of adults with desmoid tumors and assigned a Prescription Drug User Fee Act target action date of April 28, 2027. That date establishes the current target for the FDA to complete its review and potentially make an approval decision.
Immunome is also preparing to expand the regulatory effort internationally. The company plans to submit a Marketing Authorization Application for varegacestat to the European Medicines Agency by the end of 2026, potentially creating a path toward commercialization in both the U.S. and Europe if the necessary approvals are secured.
The progress with varegacestat comes as Immunome continues building a broader targeted oncology pipeline rather than relying on a single late-stage program. Management said three additional clinical-stage programs are now enrolling patients, giving the company multiple opportunities for future clinical and development milestones.
Among those programs, Immunome dosed the first patient in June 2026 in a Phase 1 trial of IM-1617, a potential first-in-class solid tumor antibody-drug conjugate incorporating HC74, the company’s proprietary TOP1 inhibitor payload. In July, the company dosed the first patient in a Phase 1 trial of IM-3050, an investigational fibroblast activation protein-targeted radioligand therapy designed to deliver radioactive lutetium-177 directly to FAP-expressing cells.
The combination of a late-stage asset already under FDA review and an expanding group of early-stage clinical programs represents the next phase of Immunome’s strategy to build a diversified targeted oncology company. Management expects the broader pipeline to generate additional milestones as varegacestat progresses toward the April 2027 FDA decision and a potential commercial launch.
KEY QUOTES:
“We continue to execute against our strategy of building a diversified targeted oncology company with multiple opportunities to bring needed therapies to patients. For varegacestat, the presentation of detailed Phase 3 RINGSIDE data at ASCO and subsequent FDA acceptance of our NDA with a PDUFA target action date of April 28, 2027 represent important steps toward a potential approval and launch. We are also continuing to advance our broader pipeline, with three additional clinical-stage programs now enrolling patients. We believe this momentum positions us well for a milestone-rich second half of 2026.”
Clay B. Siegall, Ph.D., President and CEO of Immunome
