Tenax to Present Phase 3 LEVEL Trial Data at ESC Congress; Topline Results Expected in August
TENX has more than doubled off its 52-week low of $5.66.
Summary
Tenax Therapeutics will present Phase 3 LEVEL clinical trial data at the ESC Congress in August, with topline results for its PH-HFpEF drug also expected that month.
Key Events · Product Development and Regulatory · TENX
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Phase 3 LEVEL Data Presentation
Tenax Therapeutics will present results from its Phase 3 LEVEL clinical trial in a Late-Breaking Clinical Science session at the European Society of Cardiology (ESC) Congress 2026, held August 28-31 in Munich, Germany. The presentation is scheduled for August 29, 2026.
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Topline Data Expected
The company now expects to report topline data from the Phase 3 LEVEL clinical trial in August 2026, ahead of the planned database lock and statistical analysis.
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Targeting Unmet Medical Need
The LEVEL trial is evaluating TNX-103 (oral levosimendan) for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF), a prevalent condition with no currently approved treatments.
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Trial Well-Powered
A prespecified Blinded Sample Size Re-estimation (BSSR) in December 2025 demonstrated the trial is powered over 90% to detect a 25-meter change in 6-minute walk distance (6MWD), the primary endpoint.
Analysis · TENX · Life Sciences
This 8-K announces that Tenax Therapeutics will present results from its pivotal Phase 3 LEVEL clinical trial at the prestigious European Society of Cardiology (ESC) Congress in August 2026. The company also confirmed that topline data from the trial, evaluating oral levosimendan for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF), is now expected in August. This is a significant update for a drug targeting a prevalent condition with no approved treatment, indicating strong progress and a near-term catalyst for the stock.
At the time of this filing, TENX was trading at $15.05 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $352.5M. The 52-week trading range was $5.66 to $18.38. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.