Fractyl Health, Inc. GUTS
Fractyl Health, Inc. (Nasdaq: GUTS) is a cardio-renal-metabolic medical device company. Its next catalyst on record is Revita: Fractyl plans FDA De Novo marketing application submission for Revita in late Q4 2026. (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Revita — Fractyl plans FDA De Novo marketing application submission for Revita in late Q4 2026. (Q4 2026). 6 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| RJVA-001 (AAV pancreatic GLP-1 gene therapy) | Type 2 diabetes | gene therapy | Pre-clinical |
| RJVA-002 (dual GIP/GLP-1 gene therapy) | Obesity | gene therapy | Pre-clinical |
| Revita DMR System (REMAIN-1 Pivotal Cohort) | Post-GLP-1 weight maintenance | device-combination | NA_NON_THERAPEUTIC |
Recent results and decisions
- Oct 22, 2026met Revita met six-month co-primary endpoint in REMAIN-1 Pivotal Cohort with high statistical significance in weight regain versus sham.
The decision follows the Company's recent announcement of positive topline six-month results from the REMAIN-1 Pivotal Cohort, which met its prespecified six-month co-primary endpoint with high statistical significance in weight regain compared to sham (p=0.0023).
Filing - Oct 22, 2026met REMAIN-1 Pivotal Cohort met its prespecified six-month co-primary endpoint with high statistical significance in weight regain compared to sham.
The REMAIN-1 Pivotal Cohort, which met its prespecified six-month co-primary endpoint with high statistical significance in weight regain compared to sham (p=0.0023).
Filing - Oct 16, 2026met Met 6-month co-primary endpoint: weight regain 5.1% with Revita vs 8.2% with sham (80% vs 67% of weight loss retained), p=0.0023, mITT N=308; no device- or procedure-related serious AEs.
REMAIN-1 met its pre-specified six-month co-primary endpoint of weight loss retention, as patients treated with a single Revita procedure demonstrated a highly statistically significant reduction in weight regain compared to sham (p=0.0023).
Filing
5 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other pre-clinical cardio-renal-metabolic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.