{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-254189","form_type":"8-K","ticker":"ANNX","cik":"0001528115","company_name":"Annexon, Inc.","filed_at":"2023-10-11T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.379009+00:00","generated_at":"2026-06-10T01:37:59.193276+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"EMA grants orphan drug designation to ANX005 for GBS; Phase 3 enrollment complete","bullets":["European Medicines Agency granted orphan drug designation to ANX005 for Guillain-Barré Syndrome.","Target enrollment of 225 patients achieved in Phase 3 pivotal study of ANX005 in GBS.","Company on track to report topline Phase 3 data in first half of 2024.","EMA stated preliminary data show 'clinically relevant advantage' over intravenous immunoglobulin.","Orphan designation includes 10 years of EU market exclusivity and reduced regulatory fees."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-254189","json":"https://secwatch.observer/filing/0001193125-23-254189.json","markdown":"https://secwatch.observer/filing/0001193125-23-254189.md","text":"https://secwatch.observer/filing/0001193125-23-254189.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1528115/000119312523254189/0001193125-23-254189-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1528115/000119312523254189/d568195d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T01:37:59.193276+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"}