{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-300035","form_type":"8-K","ticker":"ANNX","cik":"0001528115","company_name":"Annexon, Inc.","filed_at":"2023-12-20T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.379645+00:00","generated_at":"2026-06-07T09:49:04.459959+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA aligns with Annexon on vision preservation endpoint for ANX007 GA Phase 3 program; ANX1502 Ph1 positive","bullets":["FDA agrees to prevention of ≥15-letter BCVA loss as primary endpoint; no requirement for surrogate structural endpoint.","Two Phase 3 trials: ARCHER II (sham-controlled, ~400 pts, starts mid-2024) and ARROW (head-to-head vs Syfovre, ~500 pts, starts late 2024).","ANX007 Phase 2 ARCHER showed 72% risk reduction (p=0.006) in BCVA ≥15-letter loss in monthly dose arm vs sham.","ANX1502 Phase 1 healthy-volunteer data: target drug levels with BID dosing, suppressed C4d biomarker, no serious AEs.","Company plans to advance tablet formulation of ANX1502 into proof-of-concept trial in CAD patients in 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-300035","json":"https://secwatch.observer/filing/0001193125-23-300035.json","markdown":"https://secwatch.observer/filing/0001193125-23-300035.md","text":"https://secwatch.observer/filing/0001193125-23-300035.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1528115/000119312523300035/0001193125-23-300035-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1528115/000119312523300035/d649765d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T09:49:04.459959+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"}