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.
Tenax Therapeutics, Inc. (Nasdaq: TENX) is a specialty pharmaceutical company dedicated to identifying, developing, and commercializing innovative treatments for cardiovascular and pulmonary diseases with significant unmet medical needs. Headquartered in Chapel Hill, North Carolina, Tenax holds the North American rights to develop and commercialize levosimendan, a unique potassium ATP channel activator and calcium sensitizer with multiple mechanisms of action.
The company’s flagship product, levosimendan, is currently under development for treating pulmonary hypertension associated with heart failure and preserved ejection fraction (PH-HFpEF). This condition affects a growing number of patients and has high morbidity and mortality rates with no approved drug treatments. Levosimendan has shown promise in improving exercise capacity through potent dilation of central and pulmonary venous circulations, as demonstrated in the Phase 2 HELP trial.
Tenax is advancing levosimendan through the Phase 3 LEVEL study, a double-blind, randomized, placebo-controlled trial evaluating the efficacy of oral levosimendan in improving exercise tolerance in PH-HFpEF patients. The study aims to enroll approximately 152 subjects and measure outcomes through the six-minute walk distance test.
Recent milestones include the initiation of trial sites and patient enrollment in the LEVEL study, as well as securing expanded global rights for the development and commercialization of oral and subcutaneous formulations of levosimendan beyond North America. The United States Patent and Trademark Office (USPTO) recently granted Tenax a patent covering various formulations of levosimendan for improving exercise performance in PH-HFpEF patients, providing protections through December 2040.
In addition to levosimendan, Tenax is also developing a novel oral formulation of imatinib for pulmonary hypertension. The company continues to explore strategic partnerships to maximize the commercial potential of its therapies.
For more information about Tenax Therapeutics and their ongoing projects, visit www.tenaxthera.com. The company’s common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”.
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.
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.
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.
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.
Tenax Therapeutics, Inc. (Nasdaq: TENX) has announced a 1-for-20 reverse stock split effective January 4, 2023, at 5:00 PM ET. This move aims to ensure compliance with Nasdaq's minimum bid price requirement. The total shares outstanding will decrease from 45,836,215 to approximately 2,291,811. Each stockholder's percentage ownership remains unchanged, except for minor adjustments to fractional shares. The adjusted shares will start trading on January 5, 2023. The reverse split was approved in June 2022 and will not affect the number of authorized shares or their par value.
On October 10, 2022, Tenax Therapeutics (Nasdaq: TENX) presented positive data from a study on PH-HFpEF patients treated with oral levosimendan during the Heart Failure Society of America Scientific Sessions. The open-label extension of the HELP trial showed oral levosimendan was safe and effective, with improvements in heart rate, blood pressure, and walking distance. No serious adverse events were reported. The company's Chief Medical Officer emphasized its potential for daily use compared to weekly IV treatments. This data supports advancing oral levosimendan into Phase 3 testing, addressing a significant unmet need.
Tenax Therapeutics (Nasdaq: TENX) announced a strategic review process aimed at maximizing shareholder value, supported by Roth Capital Partners. The company is developing TNX-201 and TNX-103 for pulmonary diseases, both of which are Phase 3-ready. Tenax believes its current valuation does not reflect its clinical assets' potential. The strategic evaluation may include options like a sale or merger, although no results are guaranteed. Additionally, the launch of the TNX-201 Phase 3 trial for pulmonary arterial hypertension has been postponed to 2023.
Tenax Therapeutics, Inc. (NASDAQ: TENX) announced a KOL webinar on TNX-201, an oral modified release imatinib for pulmonary arterial hypertension (PAH), scheduled for June 2, 2022, at 11:00 AM ET. Esteemed experts, including Dr. Anna Hemnes and Dr. John Ryan, will discuss TNX-201's potential role in PAH treatment and share insights from the Phase 3 IMPRES trial of imatinib. The company aims to advance TNX-201's development, affirming its commitment to addressing unmet needs in cardiovascular therapies.
Tenax Therapeutics (NASDAQ: TENX) announced the successful completion of its pharmacokinetic study for TNX-201, a modified release formulation of imatinib for treating pulmonary arterial hypertension (PAH). The new formulation significantly enhances relative bioavailability while minimizing gastric release, addressing gastrointestinal side effects. Manufacturing is underway to support the upcoming Phase 3 trial, IMPROVE, with patient enrollment expected to start in the second half of 2022.
Tenax Therapeutics, Inc. (NASDAQ: TENX) announced an agreement to issue 10,596,027 Units at $0.755 each, raising approximately $8 million. Each Unit includes a pre-funded warrant and a warrant to purchase shares of common stock. The gross proceeds will support clinical trials for levosimendan and imatinib, R&D, and general corporate purposes. Additionally, existing warrants for 9,206,120 shares will have their exercise price reduced to $0.63 and their term extended by two years, along with other warrants for 7,783,616 shares.
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