{"schema_version":"secwatch.filing_event.v1","accession":"0001999371-25-014108","form_type":"8-K","ticker":"TNXP","cik":"0001430306","company_name":"Tonix Pharmaceuticals Holding Corp.","filed_at":"2025-09-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.976479+00:00","generated_at":"2026-05-17T05:23:29.056915+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Tonix plans Phase 2 trial of TNX-2900 for Prader-Willi syndrome in 2026","bullets":["TNX-2900 (intranasal magnesium-potentiated oxytocin) to enter Phase 2 in children ages 8-17.5 with PWS, starting 2026.","FDA cleared IND; Orphan Drug and Rare Pediatric Disease designations; eligible for Priority Review Voucher upon approval.","Phase 2 trial is randomized, double-blind, placebo-controlled; 12-week treatment; 3 dose arms vs placebo (1:1:1:1).","Primary endpoint: change from baseline in Hyperphagia Questionnaire (HQ-CT); secondary: behavior, caregiver burden, quality of life.","PWS affects 1 in 10,000-30,000 births; average life expectancy <30 years due to hyperphagia-driven obesity."],"urls":{"canonical":"https://secwatch.observer/filing/0001999371-25-014108","json":"https://secwatch.observer/filing/0001999371-25-014108.json","markdown":"https://secwatch.observer/filing/0001999371-25-014108.md","text":"https://secwatch.observer/filing/0001999371-25-014108.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1430306/000199937125014108/0001999371-25-014108-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1430306/000199937125014108/tnxp-8k_092925.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:23:29.056915+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"}