TNX-103 (oral levosimendan) - (LEVEL)

Aug. 29, 2026: Tenax Therapeutics (NASDAQ: TENX) reported additional Phase 3 LEVEL trial data for TNX-103 (oral levosimendan) in pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) at the ESC Congress 2026 late-breaking session.

In the overall randomized population (n=241), the primary endpoint (change in 6-minute walk distance at Week 12) and key secondary endpoint (KCCQ-TSS) were not statistically significant. TNX-103 was described as safe and well tolerated, with no significant arrhythmias.

Prespecified analyses showed greater benefit in patients with baseline 6MWD below the trial median of 333 meters (n=119). In this subgroup at Week 12, TNX-103 improved 6MWD by 26.3 meters versus placebo (LS mean change +23.7 m vs -2.6 m; p=0.0112). KCCQ-TSS improved +9.8 points vs +4.1 points on placebo. Post-hoc analyses showed RVSP decreased by 4.9 mmHg versus placebo (p=0.009) and NT-proBNP was reduced 47% versus placebo (p<0.0001).

The company said these findings support biological activity, including reductions in pulmonary pressures and cardiac wall stress, and will be used to enrich the patient population and adjust the registrational strategy for LEVEL-2, which is ongoing.