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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 (TENX) is a clinical-stage pharmaceutical company developing therapies for cardiovascular and pulmonary diseases with high unmet needs. This page provides official updates on clinical trials, regulatory milestones, and corporate developments.

Investors and researchers will find a centralized repository of press releases and verified news related to Tenax's lead candidate levosimendan, including progress on the Phase 3 LEVEL study for PH-HFpEF. Track updates on intellectual property expansions, partnership announcements, and scientific presentations.

All content is curated to meet investor needs for timely, accurate information on drug development progress. Bookmark this page for direct access to primary source materials from Tenax Therapeutics, without promotional commentary or speculative analysis.

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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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Tenax Therapeutics Inc

Nasdaq:TENX

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TENX Stock Data

21.10M
4.14M
0.24%
52.66%
11.2%
Biotechnology
Pharmaceutical Preparations
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United States
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