{"schema_version":"secwatch.filing_event.v1","accession":"0001999371-25-013498","form_type":"8-K","ticker":"TNXP","cik":"0001430306","company_name":"Tonix Pharmaceuticals Holding Corp.","filed_at":"2025-09-18T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.976284+00:00","generated_at":"2026-05-17T06:14:03.228137+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Tonix completes positive Pre-IND meeting with FDA for TNX-102 SL in MDD; IND filing Q4 2025","bullets":["FDA found proposed long-term safety data collection plan generally reasonable, potentially streamlining development.","Company plans to pursue sNDA to expand TNX-102 SL indication to include MDD.","IND filing for TNX-102 SL in MDD planned for Q4 2025; Phase 2 trial expected shortly after.","TNX-102 SL (sublingual cyclobenzaprine HCl) is already FDA-approved for fibromyalgia as Tonmya.","Decision based on exploratory findings that improving sleep quality may positively impact depressive symptoms."],"urls":{"canonical":"https://secwatch.observer/filing/0001999371-25-013498","json":"https://secwatch.observer/filing/0001999371-25-013498.json","markdown":"https://secwatch.observer/filing/0001999371-25-013498.md","text":"https://secwatch.observer/filing/0001999371-25-013498.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1430306/000199937125013498/0001999371-25-013498-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1430306/000199937125013498/tnxp_8k-091825.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T06:14:03.228137+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"}