{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-073945","form_type":"8-K","ticker":"GUTS","cik":"0001572616","company_name":"FRACTYL HEALTH, INC.","filed_at":"2025-05-19T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.834443+00:00","generated_at":"2026-05-21T01:34:02.525073+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 presents preclinical data for RJVA-001 gene therapy; CTA submission expected June 2025","bullets":["Single dose RJVA-001 in db/db mice reduced fasting blood sugar >200 mg/dL, increased fasting insulin >2-fold, prevented weight gain.","Systemic GLP-1 levels 10-20 pM, >5-fold lower than pharmacologic GLP-1 drugs (50-150 pM), potentially reducing side effects.","Nutrient-responsive GLP-1 secretion demonstrated in human beta cells and islets, mimicking natural hormone regulation.","Endoscopic ultrasound delivery in pigs achieved targeted pancreatic expression in <20 min with no observed toxicity.","First CTA module submission for RJVA-001 expected by June 2025; preliminary human data anticipated in 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-073945","json":"https://secwatch.observer/filing/0000950170-25-073945.json","markdown":"https://secwatch.observer/filing/0000950170-25-073945.md","text":"https://secwatch.observer/filing/0000950170-25-073945.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1572616/000095017025073945/0000950170-25-073945-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1572616/000095017025073945/guts-20250517.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-21T01:34:02.525073+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"}