---
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"
generated_at: "2026-10-12T15:28:33.871573+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Tenax pauses LEVEL-2 enrollment to amend criteria; seeks Type C FDA meeting on levosimendan

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-417939
- JSON: https://secwatch.observer/filing/0001193125-26-417939.json
- Plain text: https://secwatch.observer/filing/0001193125-26-417939.txt

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