BURLINGTON, Mass. — January 5, 2026 — Leads & Copy — Fractyl Health, Inc. (Nasdaq: GUTS), a metabolic therapeutics company, announced its strategic outlook for 2026, highlighting expected clinical and regulatory milestones across its Revita® and Rejuva® programs.
The company anticipates randomized 6-month data from the REMAIN-1 Midpoint Cohort in late January 2026. Topline 6-month data from the REMAIN-1 Pivotal Cohort and a potential PMA submission are expected in the second half of 2026.
Fractyl reported approximately $85.6 million in cash and cash equivalents on hand, supporting execution across planned 2026 milestones. The company received gross proceeds of $23.0 million from exercises of Tranche A warrants from August 2025 financing, providing a cash runway into early 2027.
Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health, stated that Fractyl is positioned for a definitional year with a focus on disciplined execution and an accelerating cadence of clinical and regulatory milestones. He added that the company is rapidly advancing Revita as an outpatient endoscopic therapy designed to address a root cause of obesity, with pivotal data and a potential PMA filing expected this year. Rajagopalan believes that weight loss maintenance is the new unmet need in obesity care.
In 2026, Fractyl plans to advance Revita through a series of clinical and regulatory milestones, building on progress across the REVEAL-1, REMAIN-1 Midpoint, and REMAIN-1 Pivotal Cohorts. The company is aligning clinical development with regulatory strategy and real-world implementation considerations for Revita.
Anticipated Revita milestones for 2026 include:
- Late January 2026: 6-month randomized data from the REMAIN-1 Midpoint Cohort
- Early 2026: Complete randomizations for the REMAIN-1 Pivotal Cohort
- Q2 2026: 1-year REVEAL-1 Cohort data
- Q3 2026: 1-year REMAIN-1 Midpoint Cohort data
- H2 2026: Topline 6-month randomized data from the REMAIN-1 Pivotal Cohort
- H2 2026: Potential Revita PMA filing in post-GLP-1 weight maintenance
Fractyl also plans to continue advancing its Rejuva® gene therapy platform toward clinical validation in 2026, with progress expected toward first-in-human (FIH) evaluation of its lead program, RJVA-001, in patients with inadequately controlled T2D, subject to regulatory authorization. The company completed Clinical Trial Applications (CTA) for a RJVA-001 FIH study in EU and Australia in H2 2025, setting the stage for expected dosing of first patients and preliminary data in 2026.
Anticipated Rejuva milestones for 2026 include:
- Q2 2026: Regulatory feedback on CTA for RJVA-001
- H2 2026: First-in-human dosing of RJVA-001, subject to CTA authorization, and preliminary data
As of December 31, 2025, Fractyl had approximately $81.5 million in preliminary unaudited cash and cash equivalents. An additional $4.1 million of proceeds were received on January 2, 2026, resulting in a balance of $85.6 million as of that date. The company expects its current cash and cash equivalents to fund operations through early 2027.
Brian Luque, Head of Investor Relations and Corporate Development, can be reached at IR@fractyl.com or 951.206.1200.
Source: Fractyl Health, Inc.
