{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-256378","form_type":"8-K","ticker":"NTLA","cik":"0001652130","company_name":"Intellia Therapeutics, Inc.","filed_at":"2025-10-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.050137+00:00","generated_at":"2026-05-17T01:40:10.025545+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA places clinical hold on NTLA's Phase 3 nex-z trials after Grade 4 liver event","bullets":["FDA verbally informed Intellia of clinical hold on MAGNITUDE and MAGNITUDE-2 Phase 3 trials for nex-z (nexiguran ziclumeran).","Hold follows Grade 4 liver transaminases and increased total bilirubin in a MAGNITUDE patient dosed with nex-z.","Company had temporarily paused dosing/screening on Oct 27 per protocol-defined pausing criteria.","FDA will issue a formal Clinical Hold Letter within 30 days; Intellia plans to work with FDA to resolve.","NTLA (Nasdaq) stock expected to react to this regulatory setback."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-256378","json":"https://secwatch.observer/filing/0001193125-25-256378.json","markdown":"https://secwatch.observer/filing/0001193125-25-256378.md","text":"https://secwatch.observer/filing/0001193125-25-256378.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1652130/000119312525256378/0001193125-25-256378-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1652130/000119312525256378/d98865d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T01:40:10.025545+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"}