Tenax Therapeutics releases LEVEL clinical trial results presentation

TENX•2026-09-09

The company framed the neutral topline result as a patient-selection issue and plans to reshape LEVEL-2 to enrich for more impaired patients.

Tenax Therapeutics posted a presentation detailing Phase 3 LEVEL trial results for TNX-103 (levosimendan) in PH-HFpEF.

Primary endpoint missed: 6-minute walk distance improved 14 m on TNX-103 vs 10.4 m on placebo; treatment difference 3.5 m (p=0.63).
Prespecified subgroup below median baseline 6MWD (<333 m) showed a 26.3 m placebo-adjusted improvement; 95% CI 6.0 to 46.7.
NT-proBNP fell 49% in the study; RVSP declined 3.5 mmHg, supporting a bi-ventricular hemodynamic effect.