{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-423377","form_type":"8-K","ticker":"GUTS","cik":"0001572616","company_name":"FRACTYL HEALTH, INC.","filed_at":"2026-10-16T11:01:22+00:00","discovered_at":"2026-10-16T11:05:02.151206+00:00","generated_at":"2026-10-16T11:05:09.643087+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Fractyl's Revita hits REMAIN-1 six-month endpoint, cutting post-GLP-1 weight regain 80% vs 67% sham (p=0.0023)","bullets":["Six-month co-primary endpoint met in mITT (N=308): Revita maintained ~80% of GLP-1-induced weight loss vs 67% for sham; mean weight regain 5.1% vs 8.2% (p=0.0023).","32% of Revita participants were weight-stable or lost more weight at 6 months post-GLP-1 discontinuation vs 18% for sham (post hoc; nominal p=0.020).","Dose response: 12-18 cm duodenal ablation cut regain 43% vs sham (4.7% vs 8.2%; n=107); 20 cm or more cut regain 53% (3.8%; n=47).","Safety: no device- or procedure-related serious adverse events or deaths; no unanticipated device effects at the Sept. 24, 2026 cut-off; 94% of related AEs were within 7 days.","Plans FDA De Novo submission in late Q4 2026, 12-month data plus second co-primary endpoint in Q1 2027, CPT code 1122T effective Jan 1, 2027, potential U.S. launch early 2028."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-423377","json":"https://secwatch.observer/filing/0001193125-26-423377.json","markdown":"https://secwatch.observer/filing/0001193125-26-423377.md","text":"https://secwatch.observer/filing/0001193125-26-423377.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1572616/000119312526423377/0001193125-26-423377-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1572616/000119312526423377/guts-20261016.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-16T11:05:09.643087+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}