The Tarrytown-based biotechnology firm secured the Investigational New Drug application following promising results in other oncological applications. ST316, which previously earned Orphan Drug designation for this indication, functions by selectively inhibiting the β-catenin pathway. By targeting the interaction between β-catenin and BCL9, the drug aims to stop oncogenic activity without triggering the severe gastrointestinal and bone toxicities often associated with broader Wnt pathway inhibitors.

CEO Barry Kappel noted that the company’s internal data suggests the drug’s safety profile is well-suited for FAP, where patients require long-term management. Recent data presented at the AACR2026 conference bolstered this rationale, showing a 47% objective response rate in metastatic colorectal cancer trials when combined with standard therapies. As FAP affects an estimated 1 in 5,000 to 10,000 people in the United States, the move to clinical trials marks a significant shift toward addressing a condition that currently relies almost exclusively on intensive surveillance and prophylactic surgery.