{"filing":{"accession_number":"0001193125-26-385910","cik":"0000034956","ticker":"TENX","company_name":"TENAX THERAPEUTICS, INC.","form":"8-K","filing_date":"2026-09-09","report_date":"2026-09-09","primary_document":"d43255d8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/34956/000119312526385910/d43255d8k.htm"},"events":[{"id":32206,"run_id":29587,"accession_number":"0001193125-26-385910","anchor_item_number":"7.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"The filing discloses Tenax's presentation of Phase 3 LEVEL clinical trial results for levosimendag (TNX-103) in pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF) at the Cantor Global Healthcare Conference on September 9, 2026. While the primary endpoint (6-minute walk distance) did not reach statistical significance (p=0.63), the presentation emphasizes post-hoc subgroup analyses showing meaningful treatment effects in patients with lower baseline exercise capacity and discusses strategic implications for the LEVEL-2 trial design. This is a material clinical development milestone that would affect investor assessment of the company's lead product candidate, though it is disclosed under Item 7.01 (Regulation FD Disclosure) rather than a dedicated clinical results item.","company_name":"TENAX THERAPEUTICS, INC.","ticker":"TENX","filing_date":"2026-09-09","form":"8-K","submitted_at":null,"items":[{"id":35319,"accession_number":"0001193125-26-385910","item_number":"7.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The filing discloses Tenax's presentation of Phase 3 LEVEL clinical trial results for levosimendag (TNX-103) in pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF) at the Cantor Global Healthcare Conference on September 9, 2026. While the primary endpoint (6-minute walk distance) did not reach statistical significance (p=0.63), the presentation emphasizes post-hoc subgroup analyses showing meaningful treatment effects in patients with lower baseline exercise capacity and discusses strategic implications for the LEVEL-2 trial design. This is a material clinical development milestone that would affect investor assessment of the company's lead product candidate, though it is disclosed under Item 7.01 (Regulation FD Disclosure) rather than a dedicated clinical results item.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-09T12:04:39.701781+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":35319,"accession_number":"0001193125-26-385910","item_number":"7.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The filing discloses Tenax's presentation of Phase 3 LEVEL clinical trial results for levosimendag (TNX-103) in pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF) at the Cantor Global Healthcare Conference on September 9, 2026. While the primary endpoint (6-minute walk distance) did not reach statistical significance (p=0.63), the presentation emphasizes post-hoc subgroup analyses showing meaningful treatment effects in patients with lower baseline exercise capacity and discusses strategic implications for the LEVEL-2 trial design. This is a material clinical development milestone that would affect investor assessment of the company's lead product candidate, though it is disclosed under Item 7.01 (Regulation FD Disclosure) rather than a dedicated clinical results item.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-09T12:04:39.701781+00:00","company_name":"TENAX THERAPEUTICS, INC.","ticker":"TENX","filing_date":"2026-09-09"}]}