{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-385194","form_type":"8-K","ticker":"NTLA","cik":"0001652130","company_name":"Intellia Therapeutics, Inc.","filed_at":"2026-09-08T20:05:15+00:00","discovered_at":"2026-09-08T20:06:22.657042+00:00","generated_at":"2026-09-08T20:06:59.653969+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Intellia's lonvo-z BLA accepted by FDA with Priority Review for HAE; PDUFA March 10, 2027","bullets":["FDA accepted BLA for lonvo-z (formerly NTLA-2002) for HAE with Priority Review; PDUFA target date March 10, 2027.","No advisory committee currently planned; if approved, lonvo-z would be first in vivo CRISPR therapy and only one-time HAE treatment.","Phase 3 HAELO (80 patients): 87% reduction in mean monthly attacks vs placebo (p<0.0001) during weeks 5-28.","62% of lonvo-z patients attack-free and therapy-free for 6 months vs 11% placebo (p<0.0001).","No serious adverse events in lonvo-z arm; most common TEAEs were infusion-related reactions, headache, fatigue, back pain."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-385194","json":"https://secwatch.observer/filing/0001193125-26-385194.json","markdown":"https://secwatch.observer/filing/0001193125-26-385194.md","text":"https://secwatch.observer/filing/0001193125-26-385194.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1652130/000119312526385194/0001193125-26-385194-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1652130/000119312526385194/ntla-20260908.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-08T20:06:59.653969+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"}