{"schema_version":"secwatch.filing_event.v1","accession":"0001999371-25-007790","form_type":"8-K","ticker":"TNXP","cik":"0001430306","company_name":"Tonix Pharmaceuticals Holding Corp.","filed_at":"2025-06-16T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.276364+00:00","generated_at":"2026-05-19T06:13:57.626545+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 presents positive Phase 3 TNX-102 SL data at EULAR; PDUFA Aug 15, 2025","bullets":["TNX-102 SL (sublingual cyclobenzaprine) showed statistically significant pain reduction in Phase 3 RESILIENT study at 14 weeks.","FDA PDUFA goal date for TNX-102 SL is August 15, 2025; if approved, would be first new fibromyalgia drug in >15 years.","Novel mechanism targets non-restorative sleep by acting on four post-synaptic receptors regulating sleep.","Non-opioid analgesic designed for transmucosal delivery to bypass first-pass metabolism and reduce norcyclobenzaprine accumulation.","Data presented at Annual European Congress of Rheumatology (EULAR) 2025 in Barcelona, June 11-14."],"urls":{"canonical":"https://secwatch.observer/filing/0001999371-25-007790","json":"https://secwatch.observer/filing/0001999371-25-007790.json","markdown":"https://secwatch.observer/filing/0001999371-25-007790.md","text":"https://secwatch.observer/filing/0001999371-25-007790.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1430306/000199937125007790/0001999371-25-007790-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1430306/000199937125007790/tnxp-8k_06162025.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-19T06:13:57.626545+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"}