TENAX THERAPEUTICS (TENX) Company Report

Tenpoint Therapeutics Ltd. has received FDA approval for YUVEZZI™ (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, making it the first and only dual-agent eye drop approved to treat presbyopia in adults.
YUVEZZI™ is expected to be broadly commercially available in the U.S. in Q2 2026.
The approval is supported by positive data from two pivotal Phase 3 studies, BRIO I and BRIO II, which demonstrated superior benefit over individual active components and achieved statistically significant near vision improvement over 8 hours, with no treatment-related serious adverse events observed in the 12-month safety study.
Presbyopia, the condition targeted by YUVEZZI™, affects approximately 128 million people in the U.S. and about two billion people globally.

Jan 29, 2026, 2:32 AM

Press Release

Tenax Therapeutics Announces Positive LEVEL Trial Assessment and Initiates LEVEL-2 Study

TENX

New Projects/Investments

Guidance Update

Tenax Therapeutics announced that the prespecified Blinded Sample Size Re-estimation (BSSR) for its LEVEL trial confirmed the trial is powered at well over 90% to detect a 25 meter change in the primary endpoint, 6-minute walk distance (6MWD), with no change to target enrollment.
Enrollment for the LEVEL trial is expected to be completed in the first half of 2026, with topline data anticipated in the second half of 2026.
The company has also initiated LEVEL-2, a global Phase 3 study for TNX-103 in patients with pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF), with an estimated enrollment completion by the end of 2027.

Dec 17, 2025, 10:00 PM

8-K

Tenax Therapeutics Provides Update on Phase III LEVEL Studies

TENX

Guidance Update

New Projects/Investments

Recruitment for Tenax Therapeutics' Phase III LEVEL 1 study is projected to enroll 230 subjects by 1H 2026, with top-line results expected in 2H 2026.
The sample size for the LEVEL 1 study was increased from 150 to 230 patients to de-risk the trial and maintain 90% power.
The company intends to start the LEVEL 2 study in 2025, which will feature a 26-week primary efficacy endpoint, be conducted globally, and be larger than LEVEL 1, while maintaining identical inclusion/exclusion criteria.
Levosimendan, the drug under investigation, functions as a potassium channel activator to normalize vascular tone, and the LEVEL 1 study is powered for a 25-meter treatment effect in the six-minute walk test.

Dec 4, 2025, 4:30 PM

Transcript

Tenax Therapeutics Provides Update on PH-HFpEF Clinical Trials and Financial Runway

TENX

New Projects/Investments

Guidance Update

Tenax Therapeutics is currently enrolling in a U.S. and Canadian phase III trial for PH-HFpEF, expecting to enroll 230 subjects by the first half of 2026 with data anticipated in the second half of 2026.
The company plans to announce the commencement of a second global phase III trial for PH-HFpEF in the next couple of weeks (late 2025), which will feature a 26-week endpoint.
The estimated U.S. market for PH-HFpEF patients is substantial, ranging from 2.2 to 3.7 million.
Tenax Therapeutics is funded through the end of 2027, having secured $100 million over a year ago and an additional $25 million in March.

Dec 2, 2025, 9:15 PM

Transcript

Tenax Therapeutics Provides Update on PH-HFpEF Clinical Trials and Funding

TENX

New Projects/Investments

Guidance Update

Tenax Therapeutics is currently enrolling patients in a U.S. and Canadian phase 3 trial for PH-HFpEF, which commenced in March 2024.
The company expects to enroll 230 subjects in the first half of 2026, with data anticipated in the second half of 2026.
A second, global phase 3 trial for PH-HFpEF is expected to begin in the next couple of weeks.
The U.S. market for PH-HFpEF patients is estimated to be between 2.2 and 3.7 million, representing an addressable market of $20 billion.
Tenax is funded through the end of 2027, having raised $100 million over a year ago and an additional $25 million in March 2025.

Dec 2, 2025, 9:15 PM

Transcript

Tenax Therapeutics Provides Update on PH-HFpEF Clinical Trials and Financial Runway

TENX

New Projects/Investments

Guidance Update

Funding

Tenax Therapeutics is currently enrolling patients in its U.S. and Canadian LEVEL phase 3 trial for PH-HFpEF, with enrollment of 230 subjects expected by the first half of 2025 and data anticipated in the second half of 2025.
The company plans to announce the commencement of a second global phase 3 trial for PH-HFpEF in the coming weeks, featuring a 26-week endpoint.
The U.S. market for PH-HFpEF patients is estimated at 2.2 to 3.7 million, with the LEVEL study powered to detect a 25-meter improvement in the six-minute walk.
Tenax Therapeutics is funded through the end of 2027, having secured $100 million over a year ago and an additional $25 million in March.

Dec 2, 2025, 9:15 PM

Transcript

Tenax Therapeutics Discusses Phase 3 Development of TNX-103 for PH-HFpEF

TENX

New Projects/Investments

Guidance Update

Tenax Therapeutics is developing TNX-103, an oral formulation of levosimendan, for Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF), with the Phase 3 LEVEL study expecting top-line data in the second half of 2026 and the LEVEL II study on track to initiate this year.
The Phase 2 HELP study confirmed levosimendan's ability to reduce wedge pressure with exercise, and patients transitioning from intravenous to oral formulation showed additional improvement in the six-minute walk test (another 7 meters) and a 23% reduction in natriuretic peptide levels.
The company holds four method-of-use patents for levosimendan in HFpEF/PH-HFpEF, covering various formulations and combinations, which are considered solid and run into 2040 with potential for extension.
While accelerated approval is a possibility given the unmet need, Tenax currently anticipates completing both LEVEL and LEVEL II trials before submitting for regulatory approval.

Nov 13, 2025, 9:30 PM

Transcript

Tenax Therapeutics Reports Q3 2025 Financial Results and Corporate Update

TENX

Earnings

Guidance Update

New Projects/Investments

Tenax Therapeutics reported a net loss of $15.8 million for the third quarter ended September 30, 2025, compared to a net loss of $4.0 million for the same period in 2024. Research and development expenses increased to $10.3 million for Q3 2025, up from $3.1 million in Q3 2024, while general and administrative expenses rose to $6.5 million from $1.5 million.
As of September 30, 2025, the company held $99.4 million in cash and cash equivalents, which is expected to fund operations through 2027.
Enrollment for the Phase 3 LEVEL study of TNX-103 in PH-HFpEF is anticipated to be completed with 230 patients in the first half of 2026, with topline data expected in the second half of 2026.
Tenax remains on track to initiate a second registrational Phase 3 study, LEVEL-2, in 2025. Additionally, the European Patent Office notified Tenax of its Intention to Grant a patent application providing intellectual property protection for the treatment of PH-HFpEF with levosimendan until December 2040.

Nov 12, 2025, 9:38 PM

8-K

Tenax Therapeutics Reports Q3 2025 Financial Results and Provides Corporate Update

TENX

Earnings

Guidance Update

New Projects/Investments

Tenax Therapeutics reported a net loss of $15.8 million for the third quarter of 2025, compared to a net loss of $4.0 million for the third quarter of 2024.
The company's cash and cash equivalents were $99.4 million as of September 30, 2025, and are expected to fund the Company through 2027.
Enrollment for the Phase 3 LEVEL study of TNX-103 is anticipated to be completed in the first half of 2026, with topline data expected in the second half of 2026.
Tenax remains on track to initiate a second registrational Phase 3 study, LEVEL-2, in 2025.
In September 2025, the European Patent Office notified Tenax of its intention to grant a patent for Levosimendan for treating PH-HFpEF, which will provide intellectual property protection until December 2040.

Nov 12, 2025, 9:05 PM

Press Release

Tenax Therapeutics Advances Levosimendan into Phase 3 for PH-HFpEF

TENX

New Projects/Investments

Product Launch

Guidance Update

Tenax Therapeutics is advancing its oral formulation of Levosimendan into Phase 3 development for PH-HFpEF, with the first of two trials (Level 1) currently enrolling and the second (Level 2) expected to start this year.
The company holds a worldwide license for Levosimendan and targets a significant market of an estimated 2 million patients in the U.S. and another 2 million in Europe, where there are no approved therapies.
Tenax has IP protection for this indication through 2040 and beyond, with Phase 3 trials powered for a 25-meter improvement in the six-minute walk distance.
The company reported over $100 million in cash at the end of its last reported quarter.