---
schema_version: "secwatch.filing_event.v1"
accession: "0001654954-23-007426"
form_type: "8-K"
ticker: "TENX"
cik: "0000034956"
company_name: "TENAX THERAPEUTICS, INC."
filed_at: "2023-05-31T23:59:59+00:00"
generated_at: "2026-06-14T10:55:58.998274+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Tenax Therapeutics receives USPTO Notice of Allowance for oral levosimendan patent in PH-HFpEF

## Summary
- Patent covers oral levosimendan (TNX-103) for PH-HFpEF; term through Dec 2040, possible extension beyond.
- No FDA-approved treatments exist for PH-HFpEF, affecting >1.6M North Americans, projected >2M by 2030.
- Phase 2 HELP study showed levosimendan improved 6-minute walk by 29 meters (p=0.03) vs placebo.
- Tenax intends to initiate Phase 3 trial of oral formulation in 2023; FDA agreed 6-minute walk test as primary endpoint.

## SEC filing metadata
- accession: 0001654954-23-007426
- form_type: 8-K
- ticker: TENX
- cik: 0000034956
- company_name: TENAX THERAPEUTICS, INC.
- filed_at: 2023-05-31T23:59:59+00:00
- event_type: regulatory
- 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/34956/000165495423007426/0001654954-23-007426-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/34956/000165495423007426/tenx_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001654954-23-007426
- JSON: https://secwatch.observer/filing/0001654954-23-007426.json
- Plain text: https://secwatch.observer/filing/0001654954-23-007426.txt

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