Recent Updates — TENX
Tenax Therapeutics has temporarily paused enrollment in its global Phase 3 LEVEL-2 clinical trial of oral levosimendan for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF). The pause allows the company to implement an amended protocol that enriches patient selection based on key learnings from the recently completed Phase 3 LEVEL trial. Specifically, the new criteria target patients with higher disease burden who are most likely to demonstrate improved exercise tolerance in the primary endpoint. Tenax has requested a Type C meeting with the U.S. Food and Drug Administration to discuss the overall development of levosimendan. The company remains funded through Q2 2028.
Tenax Therapeutics presented comprehensive results from its Phase 3 LEVEL trial for TNX-103 (oral levosimendan) in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF). The primary endpoint, change in six-minute walk distance (6MWD), did not reach statistical significance (treatment difference 3.5 m; p = 0.63). However, the drug significantly reduced NT-proBNP by approximately 49% and right ventricular systolic pressure (RVSP) by 3.5 mmHg. Post-hoc analyses indicated that patients with lower baseline exercise capacity (<333 m) experienced a clinically meaningful improvement of +26.3 meters in 6MWD compared to placebo. Management attributes the neutral primary result to protocol design flaws regarding patient selection and is using these insights to de-risk the upcoming LEVEL-2 trial by enriching for sicker patients with greater room for functional improvement. Tenax Therapeutics operates in the biopharmaceutical industry, developing treatments for heart failure.
Tenax Therapeutics announced topline results from its Phase 3 LEVEL clinical trial of TNX-103 (oral levosimendan) in patients with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF). The trial failed to meet its primary endpoint, showing no statistically significant improvement in the 6-minute walk distance versus placebo. However, prespecified subgroup analyses revealed a significant treatment effect in patients with higher disease burden, specifically those with baseline walk distances below the median of 333 meters, who improved by 26.3 meters compared to placebo. The drug also demonstrated strong biological activity, reducing NT-proBNP by 49% and right ventricular systolic pressure by 3.5 mmHg in the overall population. Tenax intends to request a Type C meeting with the FDA to discuss revising its development plan for TNX-103 based on these findings. The company operates as a clinical-stage pharmaceutical firm developing cardiopulmonary therapies.
Tenax Therapeutics reported second quarter 2026 financial results on July 31, 2026. The company ended the period with $118.0 million in cash and cash equivalents, extending its operational runway through the second quarter of 2028 following $13.4 million in proceeds from warrant exercises. Research and development expenses rose to $12.9 million from $6.1 million year-over-year due to costs for Phase 3 LEVEL and LEVEL-2 trials, while net loss widened to $17.8 million from $10.9 million. The company expects to report topline data from the Phase 3 LEVEL clinical trial in August 2026 and plans to present these results at the European Society of Cardiology Congress. Tenax Therapeutics is a development-stage pharmaceutical company focused on novel cardiopulmonary therapies for pulmonary hypertension associated with heart failure.
Tenax Therapeutics, Inc. announced that it will present Phase 3 LEVEL clinical trial results from a Late-Breaking Clinical Science session at the European Society of Cardiology (ESC) Congress 2026. The company expects to report topline data from the Phase 3 LEVEL clinical trial in August 2026. Tenax Therapeutics, Inc. is a biotechnology company focused on developing therapeutic solutions for cardiovascular diseases.
Tenax Therapeutics, Inc. entered into a Supply Agreement with Orion Corporation on June 29, 2026, designating Orion as the primary supplier of orally administered levosimendan for development and commercial purposes. The agreement includes cost-sharing provisions for scaling up manufacturing capabilities and has an initial five-year term. Concurrently, the parties entered into a Sixth Amendment to their existing License Agreement, which extends the regulatory approval milestone for the product in the United States to December 31, 2035. Tenax Therapeutics, Inc. is a biotechnology company focused on the development of therapeutic products.