Immunome, Inc. filed a New Drug Application with the FDA for its oral gamma‑secretase inhibitor, varegacestat, on April 29, 2026. The filing follows the Phase 3 RINGSIDE trial, which showed an 84 % reduction in the risk of disease progression or death and a 56 % objective response rate versus placebo.
The 84 % reduction translates to a hazard ratio of 0.16, a statistically significant improvement that positions varegacestat ahead of the only other approved oral therapy, nirogacestat, whose Phase 3 data reported a 41 % objective response rate. The higher response rate and oral formulation could give varegacestat a competitive edge in a market that currently relies on injectable treatments.
Desmoid tumors affect an estimated 16,600 people in the United States, with about 3,000 patients expected to be eligible for an oral therapy that could reduce treatment burden. The U.S. market for desmoid tumor therapies is projected to reach USD 2.85 billion in 2026, underscoring the commercial potential of a first‑in‑class oral agent.
Immunome has invested heavily in research and development, resulting in net losses in recent quarters. The company’s cash reserves are projected to support operations through 2027 or 2028, giving it time to pursue FDA approval and commercial launch, which the company anticipates could occur in 2027 if the regulatory review proceeds without delay.
CEO Clay B. Siegall has previously highlighted the strength of the RINGSIDE data set and expressed confidence that the NDA submission will accelerate the drug’s path to market. The filing marks a pivotal step toward transforming the treatment landscape for desmoid tumors and could position Immunome as a key player in a niche oncology segment.
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