{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-008307","form_type":"8-K","ticker":"NTLA","cik":"0001652130","company_name":"Intellia Therapeutics, Inc.","filed_at":"2026-01-09T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.769550+00:00","generated_at":"2026-05-16T11:04:14.638815+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Intellia provides update on FDA clinical hold for nex-z after patient death in MAGNITUDE trial","bullets":["Patient in MAGNITUDE Phase 3 trial for ATTR-CM died from septic shock secondary to perforated duodenal ulcer; autopsy supports clinical diagnoses.","Grade 4 liver transaminase elevations reported in <1% of >650 enrolled MAGNITUDE patients; all other cases resolved within weeks.","FDA clinical hold continues on MAGNITUDE (ATTR-CM) and MAGNITUDE-2 (ATTRv-PN) Phase 3 trials of nex-z.","No Grade 4 liver events reported in MAGNITUDE-2 (47 patients enrolled with ATTRv-PN).","Company plans to provide update after finalizing path forward with regulators."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-008307","json":"https://secwatch.observer/filing/0001193125-26-008307.json","markdown":"https://secwatch.observer/filing/0001193125-26-008307.md","text":"https://secwatch.observer/filing/0001193125-26-008307.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1652130/000119312526008307/0001193125-26-008307-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1652130/000119312526008307/d15047d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:04:14.638815+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"}