{"schema_version":"secwatch.filing_event.v1","accession":"0001654954-25-014059","form_type":"8-K","ticker":"TENX","cik":"0000034956","company_name":"TENAX THERAPEUTICS, INC.","filed_at":"2025-12-17T23:59:59+00:00","discovered_at":"2026-05-14T18:02:41.729774+00:00","generated_at":"2026-05-16T12:58:13.670068+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Tenax Therapeutics confirms LEVEL Phase 3 trial enrollment on track; initiates global LEVEL-2 study","bullets":["Blinded Sample Size Re-estimation (BSSR) shows LEVEL is powered >90% to detect 25m change in 6MWD primary endpoint.","LEVEL enrollment completion reaffirmed for H1 2026; topline data expected in H2 2026.","Global Phase 3 LEVEL-2 study initiated targeting ~540 PH-HFpEF patients; enrollment completion estimated by end of 2027.","Company plans to launch a long-term open-label extension (OLE) study for continued access to TNX-103.","Results confirm standard deviation lower than assumed 55 meters, de-risking trial design."],"urls":{"canonical":"https://secwatch.observer/filing/0001654954-25-014059","json":"https://secwatch.observer/filing/0001654954-25-014059.json","markdown":"https://secwatch.observer/filing/0001654954-25-014059.md","text":"https://secwatch.observer/filing/0001654954-25-014059.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/34956/000165495425014059/0001654954-25-014059-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/34956/000165495425014059/tennx_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T12:58:13.670068+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"}