{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-108360","form_type":"8-K","ticker":"ANVS","cik":"0001477845","company_name":"Annovis Bio, Inc.","filed_at":"2024-10-15T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.549066+00:00","generated_at":"2026-05-30T14:31:37.353495+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 Clears Annovis to Start Pivotal Phase 3 Alzheimer's Studies for Buntanetap","bullets":["FDA clearance to proceed with pivotal Phase 3 studies for buntanetap in early Alzheimer's disease.","Two trials: a 6-month symptomatic study and an 18-month disease-modifying study.","A well-executed 6-month trial may support NDA filing within one year of initiation.","No safety concerns raised; FDA confirmed liver enzymes, drug interactions, dose selection acceptable.","CEO Maria Maccecchini says trial initiation planned early 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-108360","json":"https://secwatch.observer/filing/0001104659-24-108360.json","markdown":"https://secwatch.observer/filing/0001104659-24-108360.md","text":"https://secwatch.observer/filing/0001104659-24-108360.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1477845/000110465924108360/0001104659-24-108360-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1477845/000110465924108360/tm2426152d2_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T14:31:37.353495+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"}