Tenax Therapeutics, Inc. (NASDAQ: $TENX) operates as a specialty pharmaceutical company with a primary focus on identifying, developing, and bringing to market products that target cardiovascular and pulmonary diseases characterized by significant unmet medical needs. Among its product portfolios are TNX-201 (oral enteric-coated imatinib) and TNX-103 (oral levosimendan).
The company is actively working on the dosing and formulation of imatinib mesylate, a kinase inhibitor designed for treating pulmonary arterial hypertension (PAH).
Tenax Therapeutics holds the rights to develop and commercialize intravenous (TNX-101), subcutaneous (TNX-102), and oral (TNX-103) formulations of levosimendan. Levosimendan, recognized as a calcium sensitizer and K-ATP activator, has been developed for intravenous use in hospitalized patients dealing with acutely decompensated heart failure.
As part of its clinical progress, the company has successfully concluded the Phase II trial of levosimendan in patients diagnosed with pulmonary hypertension (PH) and heart failure with preserved ejection fraction (HFpEF).
TENX Stock Soars on November 13, 2023, but Lack of Financial Data Raises Concerns
On November 13, 2023, TENX shares witnessed a substantial surge in value, jumping from the previous day’s closing price of $0.16 to an opening price of $0.32. Throughout the trading session, the stock demonstrated high volatility, with a day’s range fluctuating between $0.29 and $0.71. The trading volume for the day reached 11,781,739 shares, significantly surpassing the three-month average volume of 493,959 shares.
TENX operates in the Health Technology sector, specifically within the Pharmaceuticals: Major industry, and has exhibited promising growth in recent years, boasting an impressive earnings growth rate of +76.21% for the last year.
However, there is no available data concerning its earnings growth for the current year or the next five years. Similarly, information on the company’s revenue growth for the last year is unavailable, creating challenges in assessing TENX’s overall financial health.
Furthermore, financial ratios such as P/E ratio, Price/Sales, and Price/Book are either not applicable or not provided (listed as NM), limiting the analysis of the company’s valuation.
Despite these data gaps, TENX has attracted investor attention, evident in the notable increase in its stock price on November 13, 2023. However, it is crucial to recognize that the performance on this single day may not necessarily reflect the company’s long-term prospects.
In conclusion, while TENX experienced a significant stock value surge on November 13, 2023, the absence of specific financial data, including earnings and revenue growth, coupled with a lack of competitor data, makes a comprehensive evaluation of the company’s performance and prospects challenging.
Investors should be mindful of these limitations and exercise caution when making investment decisions related to TENX.
Why Tenax Therapeutics (TENX) Stock Is Up 100%?
Tenax Therapeutics Inc (NASDAQ: $TENX) shares surged by 105% to $0.32 on Monday morning following the FDA’s clearance of the Investigational New Drug (IND) application for TNX-103.
TNX-103 is an oral levosimendan designed to treat pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF).
This FDA clearance paves the way for the initiation of the Phase 3 LEVEL Study in the fourth quarter of 2023. The FDA’s alignment expedites the process by bypassing the need for a long-term cardiovascular outcomes trial.
Given the absence of FDA-approved treatments for PH-HFpEF, Tenax Therapeutics emphasizes that this development addresses a significant medical need.
More than two-thirds of the targeted research sites for the LEVEL Study have already been identified, including leading cardiovascular centers in the United States and Canada.
Encouragingly, a majority of the sites that participated in the previous Phase 2 HELP study have expressed their intent to participate in the LEVEL Study.
Tenax Therapeutics Announces FDA Clearance of IND for TNX-103
Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialized pharmaceutical company dedicated to identifying, developing, and commercializing products addressing cardiovascular and pulmonary diseases with significant unmet medical needs, has announced that the U.S. Food and Drug Administration (FDA) has scrutinized and approved the company’s Investigational New Drug (IND) Application for TNX-103 (oral levosimendan).
This development is intended for the treatment of pulmonary hypertension with heart failure and preserved ejection fraction (PH-HFpEF), allowing Tenax to initiate the first of two Phase 3 studies.
The upcoming study, known as the LEVEL Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients), is anticipated to commence in the fourth quarter of 2023.
Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics, expressed satisfaction with the collaborative discussions with the FDA, emphasizing the clear path for commencing LEVEL.
This includes alignment with the FDA on the primary efficacy endpoint and expected patient enrollment.
Giordano highlighted that Tenax won’t need to conduct a long-term cardiovascular outcomes trial, potentially reducing costs and expediting the registration process for TNX-103.
Given the absence of approved therapies in the U.S. for PH-HFpEF, Giordano emphasized the pressing unmet needs of patients suffering from this condition.
Dr. Sanjiv Shah, Stone Professor and Director of the HFpEF Program at Northwestern University Feinberg School of Medicine, and Chair of the LEVEL Steering Committee, underscored the importance of investigating TNX-103.
The trial is designed to advance understanding of how K+ATP activation may offer a novel approach to reducing the elevated central and venous blood pressures commonly associated with PH-HFpEF.
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