{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-26-035741","form_type":"8-K","ticker":"TNXP","cik":"0001430306","company_name":"Tonix Pharmaceuticals Holding Corp.","filed_at":"2026-08-03T11:05:25+00:00","discovered_at":"2026-08-03T11:10:00.393513+00:00","generated_at":"2026-08-03T11:10:19.141638+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Tonix receives FDA alignment on Phase 2 study design for TNX-4800 Lyme disease prevention","bullets":["FDA aligned on adaptive Phase 2 field study of TNX-4800 enrolling 3,300 adults over two seasons.","Primary efficacy endpoint: Lyme disease prevention at 6 months; key secondary at 3 months.","Manufacturing of investigational product on track for delivery to study sites in Q1 2027.","TNX-4800 is a long-acting human monoclonal antibody targeting OspA, with potential advantages over vaccines.","Majority of enrollment expected in 2028 season; may extend to 2029 if attack rate lower."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-26-035741","json":"https://secwatch.observer/filing/0001493152-26-035741.json","markdown":"https://secwatch.observer/filing/0001493152-26-035741.md","text":"https://secwatch.observer/filing/0001493152-26-035741.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1430306/000149315226035741/0001493152-26-035741-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1430306/000149315226035741/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-03T11:10:19.141638+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"}