{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-23-058974","form_type":"8-K","ticker":"IONS","cik":"0000874015","company_name":"IONIS PHARMACEUTICALS INC","filed_at":"2023-12-22T23:59:59+00:00","discovered_at":"2026-05-14T18:03:32.203371+00:00","generated_at":"2026-06-07T08:37:27.959178+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA approves Ionis/AstraZeneca WAINUA (eplontersen) for hATTR polyneuropathy","bullets":["Approval based on Phase 3 NEURO-TTRansform 35-week interim; co-primary endpoints of serum TTR and mNIS+7 and Norfolk QoL-DN showed sustained benefit.","WAINUA is the only self-administered auto-injector treatment for ATTRv-PN; available in U.S. in January 2024.","Global regulatory reviews underway; AstraZeneca holds commercialization rights outside U.S., recently expanded to Latin America.","Eplontersen also in Phase 3 CARDIO-TTRansform for ATTR-CM, fully enrolled with >1,400 patients."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-23-058974","json":"https://secwatch.observer/filing/0001140361-23-058974.json","markdown":"https://secwatch.observer/filing/0001140361-23-058974.md","text":"https://secwatch.observer/filing/0001140361-23-058974.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/874015/000114036123058974/0001140361-23-058974-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/874015/000114036123058974/ef20017247_form8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T08:37:27.959178+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"}