{"schema_version":"secwatch.filing_event.v1","accession":"0001999371-25-021194","form_type":"8-K","ticker":"TNXP","cik":"0001430306","company_name":"Tonix Pharmaceuticals Holding Corp.","filed_at":"2025-12-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.394175+00:00","generated_at":"2026-05-16T12:05:49.387761+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Tonix announces TNX-4800 Phase 1 data, plans 2026 FDA meeting for Phase 2/3 Lyme disease prevention","bullets":["Phase 1 study of TNX-4800 in 44 subjects showed mean half-life of 62-69 days; detectable up to 12 months.","Company will meet with FDA in 2026 to explore Phase 2/3 development options including a controlled human infection model (CHIM).","Expects GMP investigational product available for clinical testing in early 2027.","TNX-4800 targets OspA of Borrelia burgdorferi; designed as annual seasonal prophylaxis for Lyme disease.","Anti-drug antibodies in <10% of subjects with no impact on PK; most adverse events mild or moderate."],"urls":{"canonical":"https://secwatch.observer/filing/0001999371-25-021194","json":"https://secwatch.observer/filing/0001999371-25-021194.json","markdown":"https://secwatch.observer/filing/0001999371-25-021194.md","text":"https://secwatch.observer/filing/0001999371-25-021194.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1430306/000199937125021194/0001999371-25-021194-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1430306/000199937125021194/tonix-8k_122925.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T12:05:49.387761+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"}