secwatch.observer — SEC 8-K summary
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Issuer:     TENAX THERAPEUTICS, INC. (TENX)
CIK:        0000034956
Form:       8-K
Filed at:   2026-08-10T11:19:06+00:00
Accession:  0001193125-26-341236
Event type: other_material
Sentiment:  negative
Materiality: 0.90
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Tenax Phase 3 LEVEL trial misses primary endpoint; subgroup shows benefit in severe PH-HFpEF
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- Primary endpoint missed: 6MWD change +3.5m vs placebo (p=0.63); KCCQ-TSS also not met.
- Prespecified subgroup (baseline 6MWD <333m, n=119): +26.3m improvement vs placebo (nominal p=0.0112).
- NT-proBNP reduced 49% vs placebo (nominal p<0.0001); RVSP down 3.5 mmHg (nominal p=0.0045).
- Company to request FDA Type C meeting to discuss enrichment strategy; single Phase 3 with p=0.01 previously agreed for NDA.
- Safety: SAEs balanced (10.8% vs 10.7%); no new signals; results to be presented at ESC Congress 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/34956/000119312526341236/0001193125-26-341236-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/34956/000119312526341236/d115761d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-341236

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