---
schema_version: "secwatch.filing_event.v1"
accession: "0001654954-25-014059"
form_type: "8-K"
ticker: "TENX"
cik: "0000034956"
company_name: "TENAX THERAPEUTICS, INC."
filed_at: "2025-12-17T23:59:59+00:00"
generated_at: "2026-05-16T12:58:13.670068+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Tenax Therapeutics confirms LEVEL Phase 3 trial enrollment on track; initiates global LEVEL-2 study

## Summary
- Blinded Sample Size Re-estimation (BSSR) shows LEVEL is powered >90% to detect 25m change in 6MWD primary endpoint.
- LEVEL enrollment completion reaffirmed for H1 2026; topline data expected in H2 2026.
- Global Phase 3 LEVEL-2 study initiated targeting ~540 PH-HFpEF patients; enrollment completion estimated by end of 2027.
- Company plans to launch a long-term open-label extension (OLE) study for continued access to TNX-103.
- Results confirm standard deviation lower than assumed 55 meters, de-risking trial design.

## SEC filing metadata
- accession: 0001654954-25-014059
- form_type: 8-K
- ticker: TENX
- cik: 0000034956
- company_name: TENAX THERAPEUTICS, INC.
- filed_at: 2025-12-17T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/34956/000165495425014059/0001654954-25-014059-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/34956/000165495425014059/tennx_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001654954-25-014059
- JSON: https://secwatch.observer/filing/0001654954-25-014059.json
- Plain text: https://secwatch.observer/filing/0001654954-25-014059.txt

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