other material
confidence high
sentiment negative
materiality 0.90
Tenax Phase 3 LEVEL trial misses primary endpoint; subgroup shows benefit in severe PH-HFpEF
TENAX THERAPEUTICS, INC.
- 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.