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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.

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”.

News

Tenax Therapeutics Announces Oral Presentation of Levosimendan for the Treatment of PH-HFpEF at THT 2024

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Tenax Therapeutics announces Dr. Sanjiv Shah's presentation on levosimendan for PH-HFpEF at THT 2024 conference in Boston.
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Tenax Therapeutics Announces Global License Amendment that Significantly Expands Rights to Levosimendan

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Tenax Therapeutics, Inc. secures global rights to levosimendan for treating pulmonary hypertension with heart failure with preserved ejection fraction, expanding territory from North America to worldwide. The agreement with Orion Corporation includes improved net sales royalty rates, modified milestone provisions, and exclusion of neurological indications from Tenax's right of first negotiation for new levosimendan applications.
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Tenax Therapeutics Announces Pricing of Approximately $9 Million Public Offering

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Tenax Therapeutics, Inc. announced the pricing of a public offering of 1,600,000 shares of its common stock and warrants to purchase up to 3,200,000 shares at a purchase price of $5.65 per share. The offering is expected to close soon, with the proceeds intended for general corporate purposes and working capital.
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Tenax Therapeutics Enrolls First Patient in Phase 3 LEVEL Study Evaluating TNX-103 (Oral Levosimendan) for the Treatment of Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

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Tenax Therapeutics, Inc. has announced the enrollment of the first patient in the Phase 3 LEVEL Study, a trial for the treatment of pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF). The study will involve 152 patients and is expected to produce topline data by the second half of 2025. The company has highlighted the reduced costs and time for the registration of TNX-103 due to the FDA not requiring a long-term cardiovascular outcomes trial, and the extensive patent estate for levosimendan until at least 2040.
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Tenax Therapeutics Announces USPTO Grants Notice of Allowance for U.S. Patent Application, Significantly Broadening IP Protection for Use of Levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

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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 Announces Reverse Stock Split

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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 Announces Professor Javed Butler, M.D., M.P.H, M.B.A., joins PH-HFpEF Scientific Advisory Board

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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 Announces FDA Clearance of IND for TNX-103 (oral levosimendan) for the Treatment of Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF), Initiation of Phase 3 sites expected 2023

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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 Issued U.S. Patent for Oral Levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

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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 Achieves Major Milestone as USPTO Grants Notice of Allowance for U.S. Patent Application Covering Use of Oral Levosimendan (TNX-103) in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

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FAQ

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

The current stock price of Tenax Therapeutics (TENX) is $5.61 as of December 20, 2024.

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

The market cap of Tenax Therapeutics (TENX) is approximately 19.0M.

What is Tenax Therapeutics' main focus?

Tenax Therapeutics is focused on identifying, developing, and commercializing treatments for cardiovascular and pulmonary diseases with high unmet medical needs.

What is levosimendan?

Levosimendan is a potassium ATP channel activator and calcium sensitizer developed by Tenax Therapeutics to improve exercise capacity in patients with pulmonary hypertension associated with heart failure and preserved ejection fraction (PH-HFpEF).

What is the Phase 3 LEVEL study?

The LEVEL study is a Phase 3, double-blind, randomized, placebo-controlled trial evaluating oral levosimendan in PH-HFpEF patients to improve their exercise capacity measured by the six-minute walk test.

What recent achievements has Tenax Therapeutics made?

Recent achievements include initiating the LEVEL study, securing global development and commercialization rights for levosimendan, and obtaining new patents to protect its intellectual property.

What conditions is Tenax Therapeutics targeting with their products?

Tenax is targeting cardiovascular and pulmonary diseases, primarily focusing on conditions like PH-HFpEF, which have high unmet medical needs.

Who are Tenax Therapeutics' partners?

Tenax collaborates with prestigious cardiovascular research institutes and Orion Corporation for the development and commercialization of levosimendan.

What is the significance of Tenax Therapeutics' latest patent?

The latest patent provides intellectual property protection for various formulations of levosimendan and its use in improving exercise performance in PH-HFpEF patients, extending through December 2040.

What is PH-HFpEF?

PH-HFpEF stands for pulmonary hypertension associated with heart failure with preserved ejection fraction, a condition with no currently approved drug treatments and high morbidity and mortality rates.

Where can I find more information about Tenax Therapeutics?

More information can be found on their official website at www.tenaxthera.com.

What is Tenax Therapeutics' stock symbol?

Tenax Therapeutics' common stock is listed on The Nasdaq Stock Market LLC under the symbol 'TENX'.

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Tenax Therapeutics, Inc.

Nasdaq:TENX

TENX Rankings

#5332 Ranked by Market Cap
N/A Ranked by Dividends

TENX Stock Data

18.95M
3.40M
0.33%
47.95%
3.1%
Biotechnology
Pharmaceutical Preparations
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United States of America
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