{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-26-015801","form_type":"8-K","ticker":"IONS","cik":"0000874015","company_name":"IONIS PHARMACEUTICALS INC","filed_at":"2026-04-21T23:59:59+00:00","discovered_at":"2026-05-14T18:02:33.842877+00:00","generated_at":"2026-05-15T05:15:00.729800+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.78,"calibrated_materiality_score":0.78,"confidence":"high","headline":"Ionis zilganersen meets primary endpoint in Alexander disease; PDUFA Sept 22, 2026","bullets":["Primary endpoint met: gait speed stabilized vs control at Week 61 (LS mean diff 33.3%, p=0.041) in patients ≥5 years.","GMFM-88 in children 2-4 years showed 22.9-point improvement vs control (nominal p=0.034).","Key secondary endpoints (MBS, PGIS, PGIC, CGIC) consistently favored zilganersen over control.","Serious TEAEs less frequent on zilganersen (37.5%) vs control (47.1%); most AEs mild/moderate.","FDA Priority Review with PDUFA action date set for September 22, 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-015801","json":"https://secwatch.observer/filing/0001140361-26-015801.json","markdown":"https://secwatch.observer/filing/0001140361-26-015801.md","text":"https://secwatch.observer/filing/0001140361-26-015801.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/874015/000114036126015801/0001140361-26-015801-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/874015/000114036126015801/ef20071051_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T05:15:00.729800+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"}