Tenax Therapeutics to present LEVEL trial data at ESC Congress

Tenax Therapeutics, Inc. (Nasdaq: TENX) announced that results from its Phase 3 LEVEL clinical trial will be presented in a Late-Breaking Clinical Science session at the European Society of Cardiology (ESC) Congress 2026, scheduled for August 28-31 in Munich, Germany.

The presentation, titled "Levosimendan in patients with pulmonary hypertension due to heart failure with preserved ejection fraction: results of the LEVEL trial," is scheduled for August 29, 2026, at 11:15 a.m. CEST. Professor Sanjiv Shah, MD, of Northwestern University will serve as presenter.

According to a press release, the company submitted an abstract in anticipation of receiving topline results in time for ESC and now expects to report trial data in August 2026. The company said it will proceed toward a planned database lock and statistical analysis in the weeks ahead.

The LEVEL trial (NCT05983250) is a Phase 3 registrational study evaluating TNX-103, an oral form of levosimendan, in patients with pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) in the United States and Canada. Enrollment of more than 230 patients was completed in March 2026.

In December 2025, a prespecified Blinded Sample Size Re-estimation indicated the trial is powered at above 90% to detect a 25-meter change in six-minute walk distance, the primary endpoint of the study.

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