secwatch.observer — SEC 8-K summary
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Issuer:     TENAX THERAPEUTICS, INC. (TENX)
CIK:        0000034956
Form:       8-K
Filed at:   2026-10-08T20:15:54+00:00
Accession:  0001193125-26-417939
Event type: other_material
Sentiment:  neutral
Materiality: 0.55
Item codes: 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/34956/000119312526417939/0001193125-26-417939-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/34956/000119312526417939/d139658d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-417939

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