Monitor for first patient dosing and preliminary data from the RJVA-001 trial in H2 2026, which will provide initial signals on safety and efficacy. The stock may be influenced by trial updates and catalyst timelines.
Price Chart
Executive Summary
Fractyl Health received Clinical Trial Application authorization in the Netherlands to initiate a Phase 1/2 first-in-human study of RJVA-001, a gene therapy candidate for type 2 diabetes. This milestone advances the company to a dual clinical-stage firm, with dosing and preliminary data expected in H2 2026. The Rejuva development is funded within existing cash runway into early 2027, with no change to capital plans.
Key Facts
- Clinical Trial Application authorized in Netherlands for Phase 1/2 study of RJVA-001, first AAV gene therapy candidate for T2D to enter clinical development
- First-in-human dosing and preliminary data expected in second half of 2026, subject to site activation
- Rejuva clinical development funded within existing cash runway into early 2027, beyond anticipated REMAIN-1 Pivotal data readout; no change to capital plans
- Study is open-label, single-ascending-dose with 3 dose cohorts (3 each) and optional expansion of up to 20 participants at optimal dose
Financial Impact
No financial figures provided; Rejuva development funded within existing cash runway into early 2027
Risk Factors
- Clinical trial failure due to safety or efficacy issues common in early-stage gene therapy
- Regulatory hurdles in other jurisdictions (e.g., Australia) where CTA has been submitted
- Dependence on successful site activation and enrollment
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-215662 |
| Document: guts-ex99_1.htm | 0001193125-26-215662 |
| Document: 0001193125-26-215662-index-headers.html | 0001193125-26-215662 |
| Document: 0001193125-26-215662-index.html | 0001193125-26-215662 |
| Document: 0001193125-26-215662.txt | 0001193125-26-215662 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 22, 2026 4d ago | 8-K | $1.13 | awaiting T+5 | — | $1.08 (−4.42%) |
Oct 16, 2026 10d ago | 8-K | $1.55 $1.08 | ▼ −30.32% | ▼ −30.42% | $1.08 (−30.32%) |
Oct 13, 2026 12d ago | SC 13G | $4.03 $1.33 | ▼ −66.96% | ▼ −65.80% | $1.08 (−73.17%) |
Aug 10, 2026 10w ago | 8-K | $0.7018 $0.7171 | ▲ +2.18% | ▲ +2.58% | $1.08 (+53.89%) |
Aug 10, 2026 10w ago | Press Release | $0.7018 $0.7171 | ▲ +2.18% | ▲ +2.58% | $1.08 (+53.89%) |
Jul 15, 2026 14w ago | 8-K | $0.9100 $0.7580 | ▼ −16.70% | ▼ −15.72% | $1.08 (+18.68%) |
Jun 12, 2026 19w ago | Institutional Cluster | $0.8500 $0.8583 | ▲ +0.98% | ▲ +0.30% | $1.08 (+27.06%) |
Jun 11, 2026 19w ago | Insider Cluster | $0.8500 $0.8583 | ▲ +0.98% | ▲ +0.30% | $1.08 (+27.06%) |
Jun 11, 2026 19w ago | Institutional Cluster | $0.7239 $0.8500 | ▲ +17.42% | ▲ +16.99% | $1.08 (+49.19%) |
Jun 4, 2026 20w ago | 8-K | $0.7340 $0.7240 | ▼ −1.36% | ▲ +1.19% | $1.08 (+47.14%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers