Fractyl Health Secures Runway into Early 2027, Anticipates Q4 Pivotal Readout
GUTS•Fractyl Health reiterated cash runway into early 2027 and affirmed key Revita® trial milestones, including REVEAL-1 1-year data in Q2 and REMAIN-1 pivotal topline results in early Q4 2026. The company also gained CTA approval for its RJVA-001 first-in-human T2D study, with dosing planned in H2 2026.
1. First Quarter Results and Cash Runway
Fractyl Health reported first-quarter 2026 financial results reflecting ongoing investments in R&D and confirmed a cash runway extending into early 2027, funding upcoming pivotal data readouts without additional financing.
2. Revita® Clinical Milestones for 2026
The company reaffirmed its Revita® weight maintenance program timeline: one-year REVEAL-1 Cohort data in Q2 2026; one-year REMAIN-1 Midpoint randomized data in Q3 2026; and six-month randomized REMAIN-1 Pivotal Cohort topline results in early Q4 2026, followed by potential FDA De Novo submission in late Q4.
3. Progress on Rejuva™ Gene Therapy Platform
Fractyl received Clinical Trial Application authorization in the Netherlands for RJVA-001, its first-in-human gene therapy for type 2 diabetes, with initial dosing and preliminary data expected in the second half of 2026 and additional sites planned in Australia.
