Biotech News
Tenax Therapeutics Announces Topline Results from Phase 3 LEVEL Clinical Trial of TNX-103 in Patients with PH-HFpEF
TNX-103 did not meet statistical significance on the primary endpoint of improvement in 6-minute walk distance versus placebo
In prespecified exploratory analyses in the overall trial population, treatment with TNX-103 resulted in a 49% greater reduction in NT-proBNP compared to placebo (nominal p74 years): +37.6 meters (95% confidence interval 14.7, 60.5), nominal p=0.0013. Mean age was 71.8 years among patients walking less than 333 meters at baseline, versus 66.5 years among those at or above that threshold.
Prespecified Exploratory Biomarker and Hemodynamic Analyses
NT-proBNP (overall population): geometric least-squares mean ratio of 0.51 versus placebo (95% confidence interval 0.43, 0.60), nominal p264–333 meters), −10.7 meters in the third (>333–384 meters) and −27.3 meters in the fourth (>384 meters).
Safety
TNX-103 was generally safe and well-tolerated in the LEVEL trial, and no new safety signals were observed.
Adverse events were reported in 86.7% of patients on TNX-103 versus 71.9% on placebo. Treatment-related adverse events were reported in 38.3% of patients in the treatment group versus 17.4% on placebo.
Serious adverse events were balanced across arms, at 10.8% on TNX-103 and 10.7% on placebo. Adverse events of special interest occurred in 9.2% versus 5.8%.
The biomarker and hemodynamic analyses described above were prespecified in the statistical analysis plan; the quartile analysis was post hoc. Nominal p-values are not adjusted for multiplicity and these analyses do not establish efficacy. Multivariable analyses are ongoing.
“We believe the data from LEVEL provide new information that will guide us toward approval. Our mission is to bring the first approved therapy to patients with PH-HFpEF. The data from LEVEL provide us with a key insight into the population that exhibits the treatment effect of TNX-103. These trial results also confirm we had the appropriate dosing in HFpEF patients, illustrate a very favorable overall pharmacokinetic profile of oral levosimendan, and demonstrate the safety of oral levosimendan. Based on the results from LEVEL, we are moving quickly to strengthen the development plan for TNX-103 to generate data we believe will support regulatory submissions,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics.
Tenax intends to request a Type C meeting with the FDA to present the complete LEVEL dataset together with the Company's recommendations, and in parallel to seek scientific consultation from the European Medicines Agency. The Company intends to enrich the study population to ensure a robust treatment effect, as demonstrated in the subgroup findings observed in LEVEL. We will discuss an enrichment strategy in the Type C meeting, along with the FDA’s previous agreement that a single Phase 3 trial with a p-value of 0.01 would be sufficient for an NDA submission for TNX-103 for the treatment of PH-HFpEF.
Full results from LEVEL will be presented in a Late-Breaking Clinical Science session at the European Society of Cardiology (ESC) Congress 2026, being held August 28-31 in Munich, Germany.
Conference Call and Webcast
Tenax will host a conference call and live webcast today, Monday, August 10, 2026 at 8:00 a.m. ET to discuss the topline LEVEL results. Members of the management team will be joined by Sanjiv Shah, MD, Director of the HFpEF Program at Northwestern University Feinberg School of Medicine and LEVEL’s Principal Investigator.
To participate in the conference call, please dial one of the following numbers and ask to join the Tenax Therapeutics call:
+1-888-349-0106 for callers in the United States
+1-412-902-0131 for international callers
The live and archived webcast of the call will be accessible from the Company’s investor relations webpage.
About Levosimendan (TNX-101, TNX-102, TNX-103)
Levosimendan is a novel, first-in-class K-ATP channel activator/calcium sensitizer currently being evaluated to treat pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (PH-HFpEF). Levosimendan was first developed for intravenous use in hospitalized patients with acutely decompensated heart failure, and it has received market authorization in 60 countries in this indication, although it is not available in the United States or Canada. Tenax’s Phase 2 HELP study, including its open-label extension stage, demonstrated the potential of IV (TNX-101) and oral (TNX-103) levosimendan to bring durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF. TNX-103 (oral levosimendan) is currently being evaluated in LEVEL-2, a Phase 3, double-blind, randomized, placebo-controlled clinical trial in patients with PH-HFpEF.
About Tenax Therapeutics
Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. The Company owns global rights to develop and commercialize levosimendan, which it is developing for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension globally, for which no product has been approved to date. For more information, visit www.tenaxthera.com . Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”.
Caution Regarding Forward-Looking Statements
Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning our clinical data, our regulatory plans, our future trial designs, and our possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: risks of our clinical trials, including, but not limited to, the results of such trials, and the design, timing, delays, costs, location, initiation, and enrollment of any future trials; any delays in regulatory review and approval of product candidates in development; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; risks related to our business strategy, including the prioritization and development of product candidates; reliance on third parties, including Orion Corporation, our manufacturers and CROs; our estimates regarding the potential market opportunity for our product candidates; cash usage and runway may not be within management’s expected ranges; the potential advantages of our product candidates; our competitive position; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including our executives and members of our Board of Directors; risks associated with our cash needs; intellectual property risks; volatility and uncertainty in the global economy and financial markets in light of unexpected changes in tariffs and the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; changes in legal, regulatory and legislative environments in the markets in which we operate, and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law.
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