{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-073988","form_type":"8-K","ticker":"GUTS","cik":"0001572616","company_name":"FRACTYL HEALTH, INC.","filed_at":"2025-05-19T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.834710+00:00","generated_at":"2026-05-21T01:34:27.049313+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Fractyl Health submits first CTA module in Europe for RJVA-001 gene therapy in type 2 diabetes","bullets":["Submitted first Clinical Trial Application module in Europe for RJVA-001, a gene therapy for type 2 diabetes.","Expects to dose first patients and report preliminary data in 2026, pending CTA authorization.","Phase 1/2 study: open-label, dose escalation; primary endpoints safety/tolerability, secondary HbA1c and fasting glucose.","Preclinical data (ASGCT 2025) showed safety, dose-dependent potency, adaptive nutrient-responsive secretion with low circulating GLP-1.","Company targets durable disease remission via one-time therapy, reducing burden of lifelong injectable GLP-1 drugs."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-073988","json":"https://secwatch.observer/filing/0000950170-25-073988.json","markdown":"https://secwatch.observer/filing/0000950170-25-073988.md","text":"https://secwatch.observer/filing/0000950170-25-073988.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1572616/000095017025073988/0000950170-25-073988-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1572616/000095017025073988/guts-20250519.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-21T01:34:27.049313+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"}