Fractyl Health outlines strategic outlook for 2026

Fractyl Health (GUTS) outlined its strategic outlook for 2026, highlighting anticipated clinical and regulatory milestones across its Revita and Rejuva programs. “As we enter 2026, we believe Fractyl is positioned for a definitional year, and our focus is on disciplined execution with an accelerating cadence of clinical and regulatory milestones and progress,” said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health. “We are rapidly advancing Revita as an outpatient endoscopic therapy designed to address a root cause of obesity. This year, we expect to deliver pivotal data and potential PMA filing in what we see as the single biggest problem in obesity today: post-GLP-1 weight maintenance. With millions of patients expected to start and then stop taking a GLP-1 this year, we believe weight loss maintenance is the new unmet need in obesity care, and is clearly what patients, prescribers, payers, and the broader health economic community are looking for.” In 2026, the company plans to advance Revita through a series of important clinical and regulatory milestones, building on continued progress across the REVEAL-1, REMAIN-1 Midpoint, and REMAIN-1 Pivotal Cohorts as the program moves through pivotal validation in post-GLP-1 weight maintenance. In parallel, Fractyl is aligning clinical development with regulatory strategy and real-world implementation considerations for Revita as the company advances through a registrational year. Fractyl plans to continue advancing its Rejuva gene therapy platform toward clinical validation in 2026, with progress expected toward first-in-human evaluation of its lead program, RJVA-001, in patients with inadequately controlled T2D, subject to regulatory authorization. Fractyl’s current cash and cash equivalents are expected to fund its operations through early 2027 and support execution across planned 2026 clinical and regulatory milestones.