---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-215662"
form_type: "8-K"
ticker: "GUTS"
cik: "0001572616"
company_name: "FRACTYL HEALTH, INC."
filed_at: "2026-05-11T23:59:59+00:00"
generated_at: "2026-05-14T18:37:57.338350+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Fractyl Health gets Dutch authorization for first-in-human trial of RJVA-001 gene therapy for T2D

## Summary
- Received Clinical Trial Application authorization in the Netherlands for Phase 1/2 first-in-human study of RJVA-001.
- RJVA-001 is the first AAV gene therapy candidate to enter clinical development for type 2 diabetes.
- First patient dosing and preliminary data expected in the second half of 2026, subject to site activation.
- Rejuva clinical development funded within existing cash runway into early 2027; no change to capital plans.
- Fractyl becomes dual clinical-stage with Revita in pivotal development and Rejuva entering first-in-human studies.

## SEC filing metadata
- accession: 0001193125-26-215662
- form_type: 8-K
- ticker: GUTS
- cik: 0001572616
- company_name: FRACTYL HEALTH, INC.
- filed_at: 2026-05-11T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1572616/000119312526215662/0001193125-26-215662-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1572616/000119312526215662/guts-20260511.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-215662
- JSON: https://secwatch.observer/filing/0001193125-26-215662.json
- Plain text: https://secwatch.observer/filing/0001193125-26-215662.txt

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