Catalysts / GUTS
Upcoming FDA decisions and readouts we track for Fractyl Health, each with the filing that announced it.
FreeBioList tracks 3 upcoming catalysts for Fractyl Health (GUTS, listed on Nasdaq). They cover 2 programmes: Revita (Post-GLP-1 weight maintenance — 6-month randomised data; Post-GLP-1 weight maintenance — one-year data) and RJVA-001 (Type 2 diabetes (pancreatic gene therapy)).
First on the list: the Clinical readout for Revita (Post-GLP-1 weight maintenance — 6-month randomised data), guided by the company to Q4 2026. The furthest-out event tracked is Q1 2027. By stage, the upcoming rows are 1 Phase 1 readout and 2 Clinical readouts.
All 3 rows link to SEC filings (8-K or 6-K). All have been verified by a person reading the filing itself, most recently on 12 Sep 2026. The methodology page explains each status.
Background reading: Clinical trial phases explained: Phase 1 to Phase 4.
| Company ▾ | Drug ▾ | Effect / indication | Next catalyst ▾ | Phase / type ▾ | Status ▾ | Source | Options |
|---|---|---|---|---|---|---|---|
| Fractyl Health GUTS · Nasdaq | Revita | Post-GLP-1 weight maintenance — 6-month randomised data | Q4 2026 company guidance |
Clinical readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Fractyl Health GUTS · Nasdaq | RJVA-001 | Type 2 diabetes (pancreatic gene therapy) | H2 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Fractyl Health GUTS · Nasdaq | Revita | Post-GLP-1 weight maintenance — one-year data | Q1 2027 company guidance |
Clinical readout | Verified | 8-K exhibit 99.1 ↗ | No |
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