Tenax Therapeutics Inc. (NASDAQ:TENX) stock is trading lower on Monday after the company reported topline results from its Phase 3 LEVEL study evaluating oral levosimendan (TNX-103) in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF).
• Tenax Therapeutics stock is testing lower boundaries. Why is TENX stock at lows?
PH-HFpEF is a complex condition where stiffening of the left side of the heart causes blood to back up into the lungs, raising pressure in the pulmonary blood vessels even though the heart’s pumping capacity remains normal.
Although the trial missed its primary endpoint for exercise capacity improvement and its key secondary symptom score target, the company plans to request a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss modifying its development program based on encouraging subgroup findings.
The trial evaluated 241 randomized patients.
Tenax Phase 3 LEVEL Trial Key Findings
At Week 12, the primary endpoint measuring six-minute walk distance demonstrated a least-squares mean difference of 3.5 meters favoring TNX-103, which was not statistically significant.
Similarly, the key secondary endpoint measuring the Kansas City Cardiomyopathy Questionnaire total symptom score showed a minimal difference of 0.1 points between treatment groups.
Promising Subgroup Results and Biomarkers
Despite missing topline targets, prespecified subgroup analyses identified distinct clinical benefits among individuals with greater disease severity.
Patients with baseline walking distances under 333 meters demonstrated a nominal 26.3-meter improvement over placebo, while older age brackets also showed marked gains.
Furthermore, exploratory analyses demonstrated a 49% reduction in NT-proBNP cardiac stress markers compared to placebo, alongside statistically significant reductions in right ventricular systolic pressure.
Safety Profile and Regulatory Plans
TNX-103 was generally well-tolerated with no new safety concerns. Serious adverse events remained balanced between arms, occurring in 10.8% of TNX-103 patients and 10.7% on placebo.
Tenax intends to use these findings to seek European scientific consultation and present an enriched study design to the FDA.
TENX Stock Price Activity: Tenax Therapeutics shares were down 89.49% at $1.79 at the time of publication on Monday, according to Benzinga Pro data.
Image via Shutterstock/ ESB Professional
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