{"schema_version":"secwatch.filing_event.v1","accession":"0001999371-25-011478","form_type":"8-K","ticker":"TNXP","cik":"0001430306","company_name":"Tonix Pharmaceuticals Holding Corp.","filed_at":"2025-08-15T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.975675+00:00","generated_at":"2026-05-17T12:22:15.550485+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA approves Tonix's Tonmya for fibromyalgia; first new therapy in over 15 years","bullets":["Tonmya (cyclobenzaprine HCl sublingual tablets) approved for adults with fibromyalgia; Q4 2025 commercial launch expected.","Approval based on two Phase 3 trials (~1,000 patients) showing significant pain reduction vs placebo at 14 weeks.","Over 10 million U.S. adults affected; Tonmya is first-in-class non-opioid bedtime analgesic.","Company to host webcast August 18 at 8:30 AM ET to discuss approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001999371-25-011478","json":"https://secwatch.observer/filing/0001999371-25-011478.json","markdown":"https://secwatch.observer/filing/0001999371-25-011478.md","text":"https://secwatch.observer/filing/0001999371-25-011478.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1430306/000199937125011478/0001999371-25-011478-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1430306/000199937125011478/tnxp_8k-081525.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T12:22:15.550485+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"}