Tenax Therapeutics Announces Late-Breaking Presentation of LEVEL Clinical Trial Data at ESC Congress 2026

Tenax Therapeutics (Nasdaq:TENX) will present Phase 3 LEVEL trial data as a Late-Breaking Clinical Science session at ESC Congress 2026 in Munich.

Rhea-AI Summary

Tenax Therapeutics (Nasdaq:TENX) will present Phase 3 LEVEL trial data as a Late-Breaking Clinical Science session at ESC Congress 2026 in Munich. The registrational study evaluates TNX-103 (oral levosimendan) in PH-HFpEF. Topline results are expected in August 2026 following database lock and analysis.

Argus Jul 2 session

+16.33% close to close Open Argus

Details

Market reaction after Phase 3 LEVEL clinical data presentation: TENX +16.33% in the Jul 2 session

In the Jul 2 session, TENX gained 16.33%, reflecting a significant positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock surged +16.3% in the session following this news. A strong upside reaction would echo prio...

Analysis

The stock surged +16.3% in the session following this news. A strong upside reaction would echo prior clinical-trial headlines that saw average moves near 3.3%, but on a larger scale. History shows positive responses to PH-HFpEF progress, while an effective shelf and elevated short interest could temper how long enthusiasm lasts.

Key Figures

ESC Congress dates: August 28-31, 2026 Presentation time: 11:15-11:30 CEST Enrollment: over 230 patients +5 more

ESC Congress dates

August 28-31, 2026

ESC Congress 2026 in Munich

Presentation time

11:15-11:30 CEST

LEVEL Phase 3 late-breaking session on August 29, 2026

Enrollment

over 230 patients

LEVEL Phase 3 trial enrollment completed March 2026

Trial registration

NCT05983250

ClinicalTrials.gov identifier for LEVEL Phase 3 trial

Statistical power

well over 90%

Power to detect change in primary endpoint per BSSR

Primary endpoint delta

25 meters

Change in 6-minute walk distance (6MWD) primary endpoint

Functional test duration

6 minutes

6-minute walk distance functional capacity assessment

Phase

Phase 3

LEVEL registrational trial of TNX-103

Previous Clinical trial Reports

2 past events · Latest: Sep 16

Same Type 2 events

1. Sep 16

   Patent protection

   24h Move

   +3.5%

   EPO signaled intent to grant PH-HFpEF levosimendan patent protection.

2. Mar 05

   Trial expansion

   24h Move

   +3.1%

   FDA cleared LEVEL expansion and LEVEL-2 start, boosting Phase 3 program scale.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

late-breaking clinical science, phase 3, pulmonary hypertension, heart failure with preserved ejection fraction, +2 more

6 terms

late-breaking clinical science medical

"will be presented in a Late-Breaking Clinical Science session at the European"

Late-breaking clinical science describes newly released or last-minute medical study results that were not available until shortly before a conference presentation or public announcement and that have the potential to change how a drug, treatment, or medical device is viewed. For investors it matters because these results can quickly alter expectations about safety, effectiveness, regulatory approval, or market opportunity—similar to a sudden weather update that forces everyone to change travel plans and recalibrate forecasts.

phase 3 medical

"results from the Phase 3 LEVEL clinical trial will be presented in a"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

pulmonary hypertension medical

"levosimendan in patients with pulmonary hypertension due to heart failure"

Pulmonary hypertension is a condition where the blood vessels in the lungs become narrowed or stiff, forcing the right side of the heart to work much harder to push blood through—imagine a pump trying to push water through narrower pipes. For investors, it matters because the condition drives demand for diagnostic tests, ongoing treatments, and new drugs; changes in clinical trial results, approvals, or treatment guidelines can meaningfully affect the commercial prospects and costs for companies focused on this disease.

heart failure with preserved ejection fraction medical

"pulmonary hypertension due to heart failure with preserved ejection fraction"

A form of heart disease where the heart muscle pumps out a normal share of blood each beat but struggles to relax and fill properly, like a pump that can push water out but has trouble drawing enough back in between cycles. It matters to investors because it drives large and growing demand for treatments, hospital care and diagnostic tests, influences clinical trial design and regulatory decisions, and can affect the commercial prospects of drugs and medical devices.

6-minute walk distance medical

"detect a 25-meter change in 6-minute walk distance (6MWD), the primary endpoint."

A 6-minute walk distance is a simple clinical test that measures how far a person can walk on a flat surface in six minutes, used to gauge heart and lung function and overall physical stamina. Investors care because changes in this distance are often used as a clear, quantifiable indicator of a treatment’s real-world benefit in clinical trials, which can influence regulatory decisions, market adoption and a company’s valuation.

blinded sample size re-estimation technical

"a prespecified Blinded Sample Size Re-estimation (BSSR) demonstrated the trial"

A blinded sample size re-estimation is a mid-study check that adjusts how many participants a clinical trial needs based on aggregated data like event rates or variability, done without revealing who received the experimental treatment or control. For investors, it matters because changing the required number of participants can alter a trial’s cost, timeline and chances of producing reliable results—like increasing a recipe’s ingredient amounts mid-cook when you see the dish isn’t turning out as expected, but doing so without knowing which ingredient caused the issue.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Abstract recently submitted in anticipation of initial data analysis ahead of ESC

Company expects to report topline LEVEL results in August

CHAPEL HILL, N.C., July 02, 2026 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”) announced today that results from the Phase 3 LEVEL clinical trial 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.

In anticipation of potentially receiving topline results from the LEVEL clinical trial in time for presentation at ESC, an abstract was recently submitted. The Company now expects to report data in August 2026, and in the weeks ahead will proceed towards the planned database lock and statistical analysis.

Presentation Details

• Title: “Levosimendan in patients with pulmonary hypertension due to heart failure with preserved ejection fraction: results of the LEVEL trial”
• Presenter: Professor Sanjiv Shah, MD, Northwestern University
• Presentation Date/Time: Saturday, 29 August 2026, 11:15-11:30 CEST
• Location: Messe München GmbH, Munich, Germany

LEVEL (NCT05983250) is a registrational Phase 3 clinical trial evaluating TNX-103 (oral levosimendan) in patients with pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) in the United States and Canada. Enrollment of over 230 patients was completed in March 2026. In December 2025, a prespecified Blinded Sample Size Re-estimation (BSSR) demonstrated the trial is powered at well over 90% to detect a 25-meter change in 6-minute walk distance (6MWD), the primary endpoint.

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 trials 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 timing, delays, costs, design, location, initiation, enrollment, and results of such trials; any delays in regulatory review and approval of product candidates in development; our estimates regarding the potential market opportunity for our product candidates; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; the potential advantages of our product candidates; risks related to our business strategy, including the prioritization and development of product candidates; our competitive position; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including our executives and on our Board of Directors; 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; risks associated with our cash needs; 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.

Contact:
Investor and Media:
Argot Partners
tenax@argotpartners.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is Tenax Therapeutics (TENX) presenting at ESC Congress 2026?

Tenax Therapeutics will present results from its Phase 3 LEVEL clinical trial at ESC Congress 2026. According to Tenax Therapeutics, the Late-Breaking Clinical Science presentation will highlight data on TNX-103 (oral levosimendan) in patients with pulmonary hypertension due to heart failure with preserved ejection fraction.

When will Tenax Therapeutics report topline LEVEL Phase 3 results for TENX?

Tenax Therapeutics expects to report topline LEVEL Phase 3 results in August 2026. According to Tenax Therapeutics, database lock and statistical analysis are planned in the coming weeks, aiming to enable presentation of initial data at ESC Congress 2026 in Munich.

What is the design of the LEVEL Phase 3 trial of TNX-103 for PH-HFpEF?

The LEVEL study is a registrational Phase 3 trial evaluating TNX-103 (oral levosimendan) in PH-HFpEF patients in the United States and Canada. According to Tenax Therapeutics, enrollment of over 230 patients was completed in March 2026, with 6-minute walk distance as the primary endpoint.

How is the LEVEL trial for Tenax Therapeutics (TENX) powered statistically?

A prespecified blinded sample size re-estimation in December 2025 indicated strong statistical power. According to Tenax Therapeutics, the LEVEL trial is powered at well over 90% to detect a 25-meter change in 6-minute walk distance, the primary efficacy endpoint.

When and where is the Tenax Therapeutics LEVEL trial presentation at ESC 2026?

The LEVEL trial results will be presented on Saturday, 29 August 2026, from 11:15 to 11:30 CEST. According to Tenax Therapeutics, the Late-Breaking Clinical Science session will take place at Messe München GmbH during the ESC Congress 2026 in Munich, Germany.