{"schema_version":"secwatch.filing_event.v1","accession":"0001999371-25-011510","form_type":"8-K","ticker":"TNXP","cik":"0001430306","company_name":"Tonix Pharmaceuticals Holding Corp.","filed_at":"2025-08-18T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.975882+00:00","generated_at":"2026-05-17T11:51:55.138516+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.95,"calibrated_materiality_score":0.95,"confidence":"high","headline":"Tonix receives FDA approval of Tonmya (cyclobenzaprine HCl) for fibromyalgia in adults","bullets":["FDA approved Tonmya (cyclobenzaprine HCl sublingual tablets) for treatment of fibromyalgia in adults.","Product launch and commercialization strategy underway; commercial team led by Thomas Englese.","Webcast and conference call held August 18, 2025 to discuss approval and go-to-market plan.","Management presented on product label, market opportunity, and key clinical data from TNX-102 SL trials."],"urls":{"canonical":"https://secwatch.observer/filing/0001999371-25-011510","json":"https://secwatch.observer/filing/0001999371-25-011510.json","markdown":"https://secwatch.observer/filing/0001999371-25-011510.md","text":"https://secwatch.observer/filing/0001999371-25-011510.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1430306/000199937125011510/0001999371-25-011510-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1430306/000199937125011510/tnxp-8k_081825.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T11:51:55.138516+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"}