Fractyl Health Outlines Its Strategic Outlook For 2026, Highlighting Anticipated Clinical And Regulatory Milestones Across Its Revita And Rejuva Programs, Cash Balance Of $85.6M Is Expected To Provide Cash Runway Through Early 2027

Revita
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.

Anticipated 2026 Revita Milestones

• 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

Rejuva
Fractyl 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. In H2 2025, Fractyl completed Clinical Trial Applications (CTA) for a RJVA-001 FIH study in EU and Australia, setting the stage for expected dosing of first patients and preliminary data in 2026.

Anticipated 2026 Rejuva Milestones

• 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