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Tenax Therapeutics Inc - TENX STOCK NEWS

Welcome to our dedicated page for Tenax Therapeutics news (Ticker: TENX), a resource for investors and traders seeking the latest updates and insights on Tenax Therapeutics stock.

Company Overview

Tenax Therapeutics Inc (TENX) is a Phase 3, development-stage specialty pharmaceutical company committed to addressing critical cardiovascular and pulmonary diseases. With a sharp focus on conditions with high unmet medical needs, Tenax integrates advanced drug development strategies with robust clinical research to bring innovative therapeutic solutions to market. The company places a strong emphasis on scientific validation, clinical excellence, and comprehensive intellectual property protection.

Core Focus and Therapeutic Areas

The primary focus of Tenax Therapeutics is on developing and commercializing pharmaceutical products that target cardiovascular and pulmonary conditions. Utilizing industry-specific keywords such as cardiovascular therapy, pulmonary disease, and levosimendan, the company is dedicated to addressing complex conditions like pulmonary hypertension associated with Heart Failure with preserved Ejection Fraction (PH-HFpEF). These areas are chosen due to the substantial unmet medical need and the potential to significantly improve patient outcomes.

Innovative Product Pipeline

Tenax Therapeutics is at the forefront of developing a pipeline centered around levosimendan, a unique agent characterized by its ability to modulate the heart and vascular system through mechanisms involving potassium ATP channel activation and calcium sensitization. The company’s integrated development program not only explores various formulations—oral, intravenous, and subcutaneous—but also strategically expands its intellectual property portfolio to safeguard these innovations. Through its key programs, Tenax aims to demonstrate clinical benefits such as improved exercise tolerance and symptomatic relief in patients suffering from severe cardiovascular and pulmonary conditions.

Clinical Studies and Regulatory Approach

A cornerstone of Tenax’s strategy is the rigorous execution of clinical trials, including the pivotal Phase 3 LEVEL study. This double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of oral levosimendan (TNX-103) in patients with PH-HFpEF. By leveraging well-structured clinical pathways and engaging with globally recognized experts, the company underscores its commitment to achieving clear, evidence-based outcomes that may fill an urgent treatment gap.

Intellectual Property and Strategic Positioning

Tenax Therapeutics places a high premium on securing its core innovations through comprehensive intellectual property protections. The company has successfully expanded its patent estate to cover multiple formulations and combinations that enhance the utility of levosimendan. This proactive approach not only secures the future commercial value of its therapies but also reinforces its competitive position in the specialty pharmaceutical landscape.

Market Position and Business Model

Operating within the highly competitive realm of specialty pharmaceuticals, Tenax Therapeutics leverages a focused business model that emphasizes clinical validation, robust IP strategies, and targeted therapeutic innovation. The company’s revenue model is built on the eventual commercialization of its novel treatments, which address critical gaps in cardiovascular and pulmonary care. By combining a scientific, stepwise clinical development process with strategic global partnerships and licensing opportunities, Tenax positions itself as an informed, research-driven entity in a niche market segment.

Research and Development Excellence

At its core, Tenax Therapeutics is driven by a commitment to research excellence and clinical precision. The company continually refines its development strategies based on emerging scientific insights and real-world clinical data. Its research initiatives not only aim to validate the therapeutic potential of levosimendan but also seek to deliver a transformative impact in treating complex cardiovascular diseases.

Conclusion

In summary, Tenax Therapeutics Inc represents a clinically focused, innovation-driven entity in the specialty pharmaceutical space. The company’s significant emphasis on addressing unmet medical needs—combined with its strategic intellectual property safeguards and rigorous clinical processes—frames its core value proposition for investors and industry analysts. With a deep commitment to advancing therapeutic innovations for critical cardiovascular and pulmonary conditions, Tenax Therapeutics continues to build a robust foundation for long-term industry relevance.

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Tenax Therapeutics, Inc. has been granted a patent providing U.S. intellectual property protection until December 2040 for the use of TNX-103, TNX-102, TNX-101, and active metabolites of levosimendan in the treatment of PH-HFpEF. The patent also covers the use of levosimendan in combination with various cardiovascular drugs for improving exercise performance in PH-HFpEF patients. The new patent broadens existing IP claims, including coverage of expanded dose ranges and drug combinations. The company aims to evaluate the clinical utility of levosimendan in other areas of cardiovascular disease, with a focus on the Phase 3 LEVEL study. This patent adds significant value to the company's IP portfolio and future drug development endeavors.
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Tenax Therapeutics, Inc. (Nasdaq: TENX) announced a 1-for-80 reverse stock split aimed at addressing Nasdaq's minimum bid price requirement. The reverse split will reduce outstanding shares from 23,862,434 to approximately 292,281, with no change to authorized shares or par value per share.
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Tenax Therapeutics, Inc. (Nasdaq: TENX) announced the appointment of Javed Butler, M.D., M.P.H, M.B.A., to the Company’s PH-HFpEF Scientific Advisory Board. Dr. Butler, a renowned clinical trialist in cardiovascular medicine, will join the distinguished SAB overseeing the development of levosimendan. This follows the FDA clearance of Tenax’s planned Phase 3 investigation of oral levosimendan in PH-HFpEF.
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Tenax Therapeutics, Inc. (Nasdaq: TENX) announces FDA clearance for Phase 3 study of TNX-103 in PH-HFpEF patients, with the first study, The LEVEL Study, set to commence in 4Q 2023. The FDA has agreed that 6MWD will be the primary endpoint for both Phase 3 studies. The Phase 3 program is designed to meet FDA's request for subject drug exposure of 300 patients for 6 months and 100 patients for 1 year. Oral levosimendan use in PH-HFpEF is protected by a USPTO granted patent until 2040. There are no FDA-approved treatments for PH-HFpEF, with an estimated prevalence of more than 2,000,000 patients in North America by 2030.
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Tenax Therapeutics, Inc. (Nasdaq: TENX) - New U.S. patent granted for oral levosimendan (TNX-103) in the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF) until December 2040. The patent broadens Tenax’s U.S. IP protection and covers the use of oral levosimendan for the treatment of PH-HFpEF, with potential to generate billions in future estimated annual sales. TNX-103, the only drug to show statistically significant improvement in the 6-minute walk endpoint in Phase 2 HELP Study, will initiate a Phase 3 trial in 2023.
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Tenax Therapeutics prioritizes the clinical development of TNX-103 (oral levosimendan) for treating pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). This condition affects over 1.6 million North Americans and is expected to exceed 2 million by 2030. The company aims to fill the gap in treatment as there are currently no FDA-approved therapies for PH-HFpEF, with plans to initiate a Phase 3 trial in 2023. The decision to focus on TNX-103 stems from its growing patent estate, potentially providing protection until 2040. A recent patent granted for intravenous levosimendan strengthens its position. Clinical data from the HELP Study supports the drug's efficacy, marking it as a significant advancement in addressing this unmet medical need.

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Tenax Therapeutics (Nasdaq: TENX) has secured U.S. Patent No. 11,607,412 for the use of IV levosimendan in treating pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF). This patent grants intellectual property protection until December 2040, supporting Tenax's strategy to develop levosimendan, which targets a significant unmet medical need affecting over 1.6 million North Americans. Currently, no FDA-approved treatments exist for PH-HFpEF. Data from the HELP Study indicates that levosimendan significantly improves exercise capacity, further validated by FDA acceptance of the 6-minute walk distance as a Phase 3 endpoint.

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Tenax Therapeutics, Inc. (Nasdaq: TENX) announced a public offering of 8,666,666 shares at $1.80 each, alongside warrants for purchasing an additional 17,333,332 shares at an exercise price of $2.25. The offering, expected to close by February 7, 2023, aims to raise approximately $15.6 million in gross proceeds. These funds will support the clinical development of imatinib for pulmonary arterial hypertension (PAH) and levosimendan for pulmonary hypertension with preserved ejection fraction (PH-HFpEF), as well as general corporate purposes. The offering is facilitated by Roth Capital Partners and complies with SEC regulations.

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Tenax Therapeutics (Nasdaq: TENX) has been granted a Notice of Allowance for its patent covering the use of IV levosimendan to treat pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). The patent is expected to provide protection until 2040, enhancing the Company’s intellectual property for levosimendan. This condition affects over 1.5 million patients in the U.S., with no FDA-approved treatments available. The HELP Study has shown levosimendan to significantly improve exercise tolerance in PH-HFpEF patients. This patent underscores the potential of Tenax's therapies to address a critical healthcare need.

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FAQ

What is the current stock price of Tenax Therapeutics (TENX)?

The current stock price of Tenax Therapeutics (TENX) is $5.75 as of April 7, 2025.

What is the market cap of Tenax Therapeutics (TENX)?

The market cap of Tenax Therapeutics (TENX) is approximately 23.6M.

What is the primary focus of Tenax Therapeutics Inc?

Tenax Therapeutics Inc is dedicated to developing and commercializing pharmaceutical products that address critical cardiovascular and pulmonary diseases with high unmet medical needs. The company emphasizes leveraging advanced clinical research to bring innovative therapies to market.

Which therapeutic area does Tenax Therapeutics prioritize?

The company prioritizes cardiovascular and pulmonary conditions, specifically targeting disorders such as pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF). Its research is concentrated on areas where clinical needs are significant and largely unmet.

What role does levosimendan play in Tenax Therapeutics' portfolio?

Levosimendan is a central element of Tenax Therapeutics’ product pipeline, used in various formulations including oral, intravenous, and subcutaneous administration. It is employed as a means to boost cardiac performance through mechanisms like potassium ATP channel activation and calcium sensitization.

What is the significance of the Phase 3 LEVEL study?

The Phase 3 LEVEL study is a pivotal clinical trial designed to evaluate the safety and efficacy of oral levosimendan in patients with PH-HFpEF. This trial underlines the company’s commitment to rigorous clinical assessment and advancing therapies for conditions with high unmet needs.

How does Tenax Therapeutics secure its innovation?

Tenax Therapeutics aggressively expands its intellectual property portfolio to protect its innovations, including multiple formulations of levosimendan and their combinations with other cardiovascular drugs. This strategy helps secure the future commercial potential of its therapies.

What distinguishes Tenax’s approach in the pharmaceutical industry?

The company’s approach is distinguished by its focus on conducting robust clinical trials, emphasizing scientific validation and active IP management. This combination of clinical rigor and strategic innovation positions Tenax Therapeutics uniquely in the specialty pharma sector.

Who are the target patients for Tenax Therapeutics' treatments?

Tenax Therapeutics targets patients suffering from severe cardiovascular and pulmonary conditions, particularly those with disorders like PH-HFpEF where effective treatments are lacking. These patients typically face high morbidity and require advanced therapeutic options.

What competitive factors contribute to Tenax Therapeutics' market positioning?

The company differentiates itself by focusing on a niche market with significant unmet medical needs, utilizing specialized clinical research and comprehensive IP strategies. This focus on scientific and clinical excellence, along with strategic global rights, bolsters its competitive position in the industry.
Tenax Therapeutics Inc

Nasdaq:TENX

TENX Rankings

TENX Stock Data

23.59M
3.96M
0.24%
52.66%
11.2%
Biotechnology
Pharmaceutical Preparations
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United States
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