{"schema_version":"secwatch.filing_event.v1","accession":"0001999371-26-005466","form_type":"8-K","ticker":"TNXP","cik":"0001430306","company_name":"Tonix Pharmaceuticals Holding Corp.","filed_at":"2026-03-10T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.065088+00:00","generated_at":"2026-05-15T15:49:22.799589+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Tonix unveils post hoc data: TONMYA pain relief from Day 2; NNT=7, NNH=26","bullets":["Post hoc analysis of Phase 3 RESILIENT trial (n=457) shows TONMYA pain improvement vs placebo from Day 2, significant through Week 14 (p<0.001).","Primary endpoint met with LS mean treatment difference of -0.65 in weekly pain score; all key secondary endpoints significant.","Pooled analysis (n=959) reports NNT for ≥30% pain reduction at Week 14 = 7 (95% CI 5-12); NNH for discontinuation = 26 (95% CI 14-110).","LHH = 3.7, indicating nearly 4-fold greater likelihood of clinical benefit vs adverse event-related discontinuation.","TONMYA launched in November 2025 as first fibromyalgia approval in 15 years; mild transient oral hypoesthesia and dysgeusia most common adverse events."],"urls":{"canonical":"https://secwatch.observer/filing/0001999371-26-005466","json":"https://secwatch.observer/filing/0001999371-26-005466.json","markdown":"https://secwatch.observer/filing/0001999371-26-005466.md","text":"https://secwatch.observer/filing/0001999371-26-005466.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1430306/000199937126005466/0001999371-26-005466-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1430306/000199937126005466/tnxp-8k_031026.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T15:49:22.799589+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"}