secwatch.observer — SEC 8-K summary
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Issuer:     TENAX THERAPEUTICS, INC. (TENX)
CIK:        0000034956
Form:       8-K
Filed at:   2025-12-17T23:59:59+00:00
Accession:  0001654954-25-014059
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/34956/000165495425014059/0001654954-25-014059-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/34956/000165495425014059/tennx_8k.htm
  HTML page:      https://secwatch.observer/filing/0001654954-25-014059

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer