{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-028228","form_type":"8-K","ticker":"GUTS","cik":"0001572616","company_name":"FRACTYL HEALTH, INC.","filed_at":"2026-01-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.493463+00:00","generated_at":"2026-05-16T06:28:12.896117+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Fractyl Health reports positive 6-month Revita data; 70% weight regain reduction in key subgroup","bullets":["Revita-treated patients (n=40) had 4.5% weight regain vs 7.5% sham at 6 months (p=0.07) in REMAIN-1 Midpoint Cohort.","In above-median GLP-1 weight loss subgroup, Revita achieved 70% relative reduction in weight regain vs sham (p=0.004).","Revita improved cardiometabolic markers: HDL +15.5 vs +3.9 mg/dL (p=0.01) and reduced sweet-food cravings (p=0.04).","No serious adverse events related to Revita; no study discontinuations due to adverse events through 6 months.","Fractyl requested FDA feedback on De Novo reclassification for Revita; feedback expected Q2 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-028228","json":"https://secwatch.observer/filing/0001193125-26-028228.json","markdown":"https://secwatch.observer/filing/0001193125-26-028228.md","text":"https://secwatch.observer/filing/0001193125-26-028228.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1572616/000119312526028228/0001193125-26-028228-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1572616/000119312526028228/guts-20260129.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T06:28:12.896117+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"}