CHAPEL HILL, N.C. - Tenax Therapeutics, Inc. (NASDAQ:TENX), a pharmaceutical company in the Phase 3 development stage, announced the grant of a new U.S. patent for its cardiovascular drug levosimendan. The patent, issued by the United States Patent and Trademark Office, extends intellectual property protection for the drug and its metabolites through December 2040, with potential for further extension.
The patent covers the use of levosimendan in various forms, including oral (TNX-103), subcutaneous (TNX-102), and intravenous (TNX-101), for treating pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). It also provides protection for the drug's active metabolites (OR1896 and OR1855) and its use in combination with other cardiovascular drugs.
Levosimendan is a unique drug that activates potassium ATP channels and sensitizes calcium, impacting the heart and vascular system through multiple modes of action. It has been approved in 60 countries outside the U.S. for acutely decompensated heart failure and is under investigation in the Phase 3 LEVEL study for its efficacy in PH-HFpEF patients.
The LEVEL study, a double-blind, randomized, placebo-controlled trial, aims to demonstrate the drug's effectiveness in improving exercise capacity, as measured by the six-minute walk distance. The HELP study previously indicated that patients with PH-HFpEF showed a significant improvement in this assessment when treated with IV levosimendan compared to placebo.
Chris Giordano, President & Chief Executive Officer of Tenax Therapeutics, emphasized the strategic importance of expanding the company's intellectual property estate for levosimendan. This move is intended to protect the commercial value of the drug as the company seeks to address the significant unmet needs in cardiovascular medicine.
PH-HFpEF is recognized as an area with high morbidity and mortality rates, lacking effective treatment options. This condition represents a growing epidemic, and the American Heart Association has highlighted the urgent need for novel therapeutic developments.
The information in this article is based on a press release statement from Tenax Therapeutics.
InvestingPro Insights
As Tenax Therapeutics, Inc. (NASDAQ:TENX) secures a new U.S. patent for its cardiovascular drug levosimendan, extending its intellectual property protection, investors may be considering the financial health and market performance of the company. According to InvestingPro data, Tenax Therapeutics holds a market capitalization of 7.19 million USD, suggesting a relatively small-cap status in the pharmaceutical industry. Despite the potential of its lead drug, the company's P/E ratio stands at -0.93 as of the last twelve months ending Q4 2023, reflecting challenges in profitability.
Furthermore, Tenax's stock has experienced significant price volatility, with a 1-month price total return of -13.44% and a 3-month price total return of -71.95%, highlighting the risks associated with investing in the stock. The company's stock is also trading near its 52-week low, with the price at 6.0% of its 52-week high, potentially indicating an undervalued position or investor caution towards the company's future prospects.
InvestingPro Tips for Tenax Therapeutics reveal that the company holds more cash than debt on its balance sheet, which can be a positive sign for financial stability. However, the company is quickly burning through cash, which could raise concerns about its long-term sustainability. Additionally, Tenax does not pay a dividend to shareholders, which may influence investment decisions for those seeking regular income streams from their stock holdings.
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