---
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"
generated_at: "2026-08-10T11:20:14.701211+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Tenax Phase 3 LEVEL trial misses primary endpoint; subgroup shows benefit in severe PH-HFpEF

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-341236
- JSON: https://secwatch.observer/filing/0001193125-26-341236.json
- Plain text: https://secwatch.observer/filing/0001193125-26-341236.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.