{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-341236","form_type":"8-K","ticker":"TENX","cik":"0000034956","company_name":"TENAX THERAPEUTICS, INC.","filed_at":"2026-08-10T11:19:06+00:00","discovered_at":"2026-08-10T11:20:06.264637+00:00","generated_at":"2026-08-10T11:20:14.701211+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Tenax Phase 3 LEVEL trial misses primary endpoint; subgroup shows benefit in severe PH-HFpEF","bullets":["Primary endpoint missed: 6MWD change +3.5m vs placebo (p=0.63); KCCQ-TSS also not met.","Prespecified subgroup (baseline 6MWD <333m, n=119): +26.3m improvement vs placebo (nominal p=0.0112).","NT-proBNP reduced 49% vs placebo (nominal p<0.0001); RVSP down 3.5 mmHg (nominal p=0.0045).","Company to request FDA Type C meeting to discuss enrichment strategy; single Phase 3 with p=0.01 previously agreed for NDA.","Safety: SAEs balanced (10.8% vs 10.7%); no new signals; results to be presented at ESC Congress 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-341236","json":"https://secwatch.observer/filing/0001193125-26-341236.json","markdown":"https://secwatch.observer/filing/0001193125-26-341236.md","text":"https://secwatch.observer/filing/0001193125-26-341236.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/34956/000119312526341236/0001193125-26-341236-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/34956/000119312526341236/d115761d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-10T11:20:14.701211+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"}