{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-153625","form_type":"8-K","ticker":"ANNX","cik":"0001528115","company_name":"Annexon, Inc.","filed_at":"2024-06-04T23:59:59+00:00","discovered_at":"2026-05-14T18:03:18.848413+00:00","generated_at":"2026-06-01T06:31:42.839330+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Annexon Phase 3 GBS trial meets primary endpoint; ANX005 shows 2.4-fold improvement on GBS-DS at week 8","bullets":["Phase 3 trial met primary endpoint: single infusion of ANX005 30 mg/kg achieved 2.4-fold improvement on GBS-DS at week 8 (p=0.0058).","Key secondary endpoints met: 28 fewer days on ventilation (p=0.0356), 31-day reduction in time to walk independently (p=0.0211), and early muscle strength gains.","ANX005 was generally well-tolerated; most adverse events mild-to-moderate, no drug-related deaths or serious infections.","RWE comparability protocol initiated with IGOS; BLA submission and RWE data expected first half 2025.","GBS affects >22,000 hospitalized annually in U.S./Europe; no FDA-approved treatments currently."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-153625","json":"https://secwatch.observer/filing/0001193125-24-153625.json","markdown":"https://secwatch.observer/filing/0001193125-24-153625.md","text":"https://secwatch.observer/filing/0001193125-24-153625.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1528115/000119312524153625/0001193125-24-153625-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1528115/000119312524153625/d838099d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T06:31:42.839330+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"}