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
GUTS biotech catalysts & pipeline
FRACTYL HEALTH INC · Data as of 2026-10-25
Upcoming catalysts
revita — NDA/BLA submission
Late Q4 2026
Late Q4 2026: Planned FDA De Novo marketing application submission for Revita in post-GLP-1 weight maintenance.Source filing
revita — Topline data
Q1 2027
Q1 2027: Anticipated topline 12-month data from the REMAIN-1 Pivotal Cohort, including the second co-primary endpoint.Source filing
revita — Regulatory decision
Late 2027
Late 2027: Potential FDA marketing authorization.Source filing