revita — Full data
Q3 2026
Next anticipated Revita ® clinical data readouts are 1-year data from the REVEAL-1 Cohort in Q2 2026 and 1-year randomized data from the REMAIN-1 Midpoint Cohort in Q3 2026Source filing
GUTS biotech catalysts & pipeline
FRACTYL HEALTH INC · Data as of 2026-09-08
Upcoming catalysts
revita — Regulatory decision
H2 2026
Upcoming randomized 6-month REMAIN-1 Midpoint Cohort data expected in January 2026; topline 6-month Pivotal Cohort data and potential PMA filing anticipated in H2 2026Source filing
RJVA-001 — Initial data
H2 2026
Fractyl expects to dose the first patient with RJVA-001 and report preliminary data in the second half of 2026, subject to site activation.Source filing
RJVA-001 — FDA meeting
Q3 2026
The Company also plans to conduct the study at sites in Australia, where a CTA has been submitted and regulatory feedback is expected in the third quarter of 2026.Source filing
RJVA-001 — Regulatory decision
Q3 2026
Fractyl also plans to conduct the study at sites in Australia, where a clinical trial application has been submitted and regulatory feedback is expected in the third quarter of 2026.Source filing
revita — Topline data
Q4 2026
REMAIN-1 Pivotal Cohort topline data on track for early Q4 2026, paving the way for potential FDA De Novo submission in post-GLP-1 weight maintenance in late Q4 2026Source filing
Revita DMR System — Topline data
Q4 2026
Next anticipated Revita® milestones are topline six-month randomized data from the REMAIN-1 Pivotal Cohort in early Q4 2026 and a potential FDA De Novo marketing application submission in late Q4 2026Source filing
revita — Topline data
Q1 2027
• Q1 2027: Topline one-year data from the REMAIN-1 Pivotal Cohort.Source filing