The strong durability signal from REVEAL-1 supports Revita's differentiation; watch for REMAIN-1 randomized data in Q3/Q4 2026 as the next major catalyst. Given small sample size and open-label design, confirmatory pivotal data will be critical for sustained upside.
Price Chart
Executive Summary
Fractyl Health reported positive one-year open-label results from the REVEAL-1 cohort, showing that a single Revita procedure allowed patients to maintain ~78% of prior GLP-1-induced weight loss at one year, with 33% continuing to lose weight and no serious adverse events. This de-risks Revita's potential as a post-GLP-1 weight maintenance therapy ahead of pivotal REMAIN-1 data in Q3/Q4 2026.
Key Facts
- Participants retained ~78% of prior GLP-1-induced weight loss at one year after a single Revita procedure (n=15).
- 33% of patients continued to lose weight one year after discontinuing GLP-1.
- Mean total body weight change was 5.3% (LS mean) at one year; comparator GLP-1 withdrawal shows ~15% weight regain.
- No procedure-related serious adverse events; mild transient events in 36% of participants.
- Next data readouts: REMAIN-1 Midpoint Cohort in Q3 2026 and REMAIN-1 Pivotal Cohort in early Q4 2026.
Financial Impact
This is a clinical-stage company with no revenue; the positive data could significantly impact valuation if pivotal trials succeed.
Risk Factors
- Open-label, single-arm design with small sample size (n=15 efficacy dataset) limits statistical robustness.
- Five participants withdrew or were lost to follow-up, potentially introducing bias.
- Regulatory and commercial adoption risks remain; rejection of Revita in pivotal trials would reset expectations.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-256445 |
| Document: guts-ex99_1.htm | 0001193125-26-256445 |
| Document: 0001193125-26-256445-index-headers.html | 0001193125-26-256445 |
| Document: 0001193125-26-256445-index.html | 0001193125-26-256445 |
| Document: 0001193125-26-256445.txt | 0001193125-26-256445 |
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