Fractyl Health outlines its strategic outlook for 2026, focusing on key clinical and regulatory milestones for its Revita and Rejuva programs.
The company has approximately $85.6 million in cash and cash equivalents to support execution across planned milestones in 2026.
Anticipated milestones include 6-month data from the REMAIN-1 Midpoint Cohort in late January 2026 and topline 6-month data from the REMAIN-1 Pivotal Cohort expected in H2 2026.
Revita Program Advancements
Revita program to deliver pivotal data and potential PMA filing addressing post-GLP-1 weight maintenance, a critical unmet need in obesity care.
Rejuva Gene Therapy Progress
Plans for clinical validation of Rejuva gene therapy platform in 2026, with RJVA-001 first-in-human dosing and preliminary data expected in H2 2026.
Financial Guidance
Fractyl had approximately $85.6 million in cash and cash equivalents as of January 2, 2026, providing funding through early 2027 for operations and milestones.
- Fractyl Health aims to redefine obesity and type 2 diabetes treatment with innovative approaches targeting root causes of the diseases.
- The company's focus on post-GLP-1 weight maintenance seeks to address a critical gap in current obesity care, catering to patient needs and healthcare economics.
With a strong financial position and a clear strategic roadmap for 2026, Fractyl Health is poised for significant advancements in metabolic therapeutics. The upcoming milestones and groundbreaking approaches signal a transformative year for the company.