---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-073374"
form_type: "8-K"
ticker: "GUTS"
cik: "0001572616"
company_name: "FRACTYL HEALTH, INC."
filed_at: "2026-02-26T23:59:59+00:00"
generated_at: "2026-05-15T23:35:18.315375+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Fractyl Health completes randomization in REMAIN-1 pivotal trial for Revita; topline data expected early Q4 2026

## Summary
- Randomization completed in double-blind, sham-controlled REMAIN-1 study for Revita in weight maintenance after GLP-1 therapy discontinuation.
- Topline 6-month pivotal data expected early Q4 2026; potential FDA marketing submission late Q4 2026.
- Cash runway reiterated into early 2027, beyond pivotal readout.
- Anticipated milestones: Q2 2026 FDA feedback on De Novo pathway, 1-year data from REVEAL-1 and REMAIN-1 Midpoint Cohort.

## SEC filing metadata
- accession: 0001193125-26-073374
- form_type: 8-K
- ticker: GUTS
- cik: 0001572616
- company_name: FRACTYL HEALTH, INC.
- filed_at: 2026-02-26T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1572616/000119312526073374/0001193125-26-073374-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1572616/000119312526073374/guts-20260226.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-073374
- JSON: https://secwatch.observer/filing/0001193125-26-073374.json
- Plain text: https://secwatch.observer/filing/0001193125-26-073374.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.