{"schema_version":"secwatch.filing_event.v1","accession":"0001654954-23-014103","form_type":"8-K","ticker":"TENX","cik":"0000034956","company_name":"TENAX THERAPEUTICS, INC.","filed_at":"2023-11-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:31.646984+00:00","generated_at":"2026-06-08T05:49:49.056734+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA clears IND for Tenax's TNX-103 (oral levosimendan) for PH-HFpEF; Phase 3 LEVEL study to start Q4 2023","bullets":["FDA cleared IND for TNX-103 (oral levosimendan) to treat PH-HFpEF, enabling Phase 3 LEVEL study in Q4 2023.","FDA agreed to 6-minute walk distance as primary endpoint; no requirement for cardiovascular outcomes trial.","Patent protection for oral levosimendan in PH-HFpEF until end of 2040; no FDA-approved treatments exist.","More than 2/3 of research sites selected; 90% of prior HELP study sites agreed to participate.","Estimated North American patient population >2 million by 2030; high unmet medical need."],"urls":{"canonical":"https://secwatch.observer/filing/0001654954-23-014103","json":"https://secwatch.observer/filing/0001654954-23-014103.json","markdown":"https://secwatch.observer/filing/0001654954-23-014103.md","text":"https://secwatch.observer/filing/0001654954-23-014103.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/34956/000165495423014103/0001654954-23-014103-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/34956/000165495423014103/tenx_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-08T05:49:49.056734+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"}