{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-218508","form_type":"8-K","ticker":"GUTS","cik":"0001572616","company_name":"FRACTYL HEALTH, INC.","filed_at":"2025-09-26T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.393231+00:00","generated_at":"2026-05-17T05:33:55.519363+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 maintains weight loss after GLP-1 stop; 2.5% further loss vs 10% regain in sham (p=0.014)","bullets":["Revita-treated patients (n=29) lost additional 2.5% total body weight at 3 months after stopping tirzepatide; sham (n=16) regained 10% (p=0.014).","No Revita-related SAEs or Grade II+ AEs observed; side effects mild/transient, consistent with prior studies.","REMAIN-1 Midpoint Cohort ongoing; 6-month data expected Q1 2026.","Pivotal cohort randomization on track for early 2026; 6-month topline data and potential PMA filing in H2 2026.","Results provide first randomized, blinded evidence of durable drug-free weight maintenance post-GLP-1."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-218508","json":"https://secwatch.observer/filing/0001193125-25-218508.json","markdown":"https://secwatch.observer/filing/0001193125-25-218508.md","text":"https://secwatch.observer/filing/0001193125-25-218508.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1572616/000119312525218508/0001193125-25-218508-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1572616/000119312525218508/d870124d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:33:55.519363+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"}