{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-048033","form_type":"8-K","ticker":"GUTS","cik":"0001572616","company_name":"FRACTYL HEALTH, INC.","filed_at":"2025-04-01T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.833898+00:00","generated_at":"2026-05-24T00:47:38.180725+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Fractyl Health reports early REVEAL-1 data suggests Revita prevents weight regain after GLP-1 stop","bullets":["First 7 patients showed average weight regain of 1.2% at 1 month vs typical ~3% after GLP-1 discontinuation.","No safety or tolerability concerns in 15 patients treated to date; consistent with prior pooled data.","REMAIN-1 pivotal study now >50% enrolled; full enrollment expected summer 2025; midpoint analysis Q3 2025.","Revita holds FDA Breakthrough Device designation for post-GLP-1 weight maintenance.","Additional REVEAL-1 follow-up data expected in Q2 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-048033","json":"https://secwatch.observer/filing/0000950170-25-048033.json","markdown":"https://secwatch.observer/filing/0000950170-25-048033.md","text":"https://secwatch.observer/filing/0000950170-25-048033.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1572616/000095017025048033/0000950170-25-048033-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1572616/000095017025048033/guts-20250401.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T00:47:38.180725+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"}