{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-076424","form_type":"8-K","ticker":"GUTS","cik":"0001572616","company_name":"FRACTYL HEALTH, INC.","filed_at":"2024-06-24T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.031152+00:00","generated_at":"2026-06-01T02:27:23.807576+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Fractyl Health accelerates REMAIN-1 study, expands REVITALIZE-1 eligibility","bullets":["REMAIN-1 weight maintenance study accelerated; open-label REVEAL-1 data expected Q4 2024.","Midpoint data analysis for REMAIN-1 now anticipated in Q2 2025.","FDA approved protocol amendment for REVITALIZE-1: expands eligibility to any glucose lowering agent; potential U.S. treatment population ~6x to ~25M patients.","Topline data from REVITALIZE-1 expected mid-2025.","Preclinical data for Rejuva gene therapy vs semaglutide showed greater, more durable weight loss in mice; presented at ADA 84th Scientific Sessions."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-076424","json":"https://secwatch.observer/filing/0000950170-24-076424.json","markdown":"https://secwatch.observer/filing/0000950170-24-076424.md","text":"https://secwatch.observer/filing/0000950170-24-076424.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1572616/000095017024076424/0000950170-24-076424-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1572616/000095017024076424/guts-20240624.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T02:27:23.807576+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"}