{"schema_version":"secwatch.filing_event.v1","accession":"0001999371-25-018430","form_type":"8-K","ticker":"TNXP","cik":"0001430306","company_name":"Tonix Pharmaceuticals Holding Corp.","filed_at":"2025-11-24T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.393559+00:00","generated_at":"2026-05-16T17:17:08.665827+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Tonix Pharma receives FDA IND clearance for TNX-102 SL Phase 2 MDD study","bullets":["FDA cleared IND for TNX-102 SL (cyclobenzaprine HCl) 5.6 mg sublingual tablets to treat major depressive disorder in adults.","Potentially pivotal Phase 2 HORIZON study: 6-week, randomized, double-blind, placebo-controlled, 360 patients at ~30 U.S. sites.","Primary endpoint: MADRS total score change from baseline at Week 6; enrollment to begin mid-2026.","TNX-102 SL targets disrupted sleep associated with MDD; prior fibromyalgia and PTSD studies showed depression symptom improvements."],"urls":{"canonical":"https://secwatch.observer/filing/0001999371-25-018430","json":"https://secwatch.observer/filing/0001999371-25-018430.json","markdown":"https://secwatch.observer/filing/0001999371-25-018430.md","text":"https://secwatch.observer/filing/0001999371-25-018430.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1430306/000199937125018430/0001999371-25-018430-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1430306/000199937125018430/tnxp-8k_112425.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T17:17:08.665827+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"}