{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-417939","form_type":"8-K","ticker":"TENX","cik":"0000034956","company_name":"TENAX THERAPEUTICS, INC.","filed_at":"2026-10-08T20:15:54+00:00","discovered_at":"2026-10-08T20:17:05.280561+00:00","generated_at":"2026-10-12T15:28:33.871573+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Tenax pauses LEVEL-2 enrollment to amend criteria; seeks Type C FDA meeting on levosimendan","bullets":["Tenax has temporarily paused enrollment in its LEVEL-2 trial of TNX-103 (levosimendan) in PH-HFpEF in order to amend the trial's enrollment criteria.","The amended criteria follow key learnings from the recently completed Phase 3 LEVEL trial; enrollment may resume at each site as the amended protocol goes into effect there.","Company requested a Type C meeting with the U.S. Food and Drug Administration to discuss the overall development of levosimendan.","Enriched enrollment targets patients LEVEL results suggest are most likely to show improved exercise tolerance on LEVEL-2's primary endpoint."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-417939","json":"https://secwatch.observer/filing/0001193125-26-417939.json","markdown":"https://secwatch.observer/filing/0001193125-26-417939.md","text":"https://secwatch.observer/filing/0001193125-26-417939.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/34956/000119312526417939/0001193125-26-417939-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/34956/000119312526417939/d139658d8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T15:28:33.871573+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"}