Tenax Therapeutics and FDA

FDA Approves Tenax Therapeutics’ TNX-103, Stock Surges 161%

Tenax Therapeutics, a specialized pharmaceutical company dedicated to identifying, developing, and commercializing products targeting cardiovascular and pulmonary diseases with high unmet medical needs, declared today that the United States Food and Drug Administration (FDA) has given its stamp of approval to the company’s Investigational New Drug (IND) Application for TNX-103 (oral levosimendan).

This breakthrough medication is designed for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). The clearance by FDA empowers Tenax Therapeutics to progress to the initial phase of two Phase 3 studies.

The announcement sparked a remarkable surge in Tenax Therapeutics’ stock, with a staggering increase of over 161% recorded on Monday morning, underscoring the market’s recognition of the potential impact of TNX-103. The drug, poised to address a critical medical void in the absence of FDA-approved treatments for PH-HFpEF, has generated significant enthusiasm among investors.

At the time of this publication, Tenax Therapeutics Inc stock (TENX) has witnessed a surge.
Tenax Therapeutics Inc
Tenax Therapeutics Inc
Current Price: $0.41
Change : +0.25
Change (%): (161.22%)
Volume: 77.8M
Source: Tomorrow Events Market Data

The forthcoming LEVEL Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients) is slated to commence in the fourth quarter of 2023. With the pivotal Phase 3 trial on the horizon, Tenax is strategically positioned to contribute to advancing the field of cardiovascular medicine.

In light of the absence of FDA approved remedies for PH-HFpEF, Tenax Therapeutics underscores the pressing medical necessity that TNX-103 aims to fulfill. More than two-thirds of the targeted research sites for the LEVEL Study have already been identified, with prominent cardiovascular centers in the United States and Canada among the selected institutions.

Encouragingly, a significant number of sites that participated in the preceding Phase 2 HELP study have expressed their commitment to participating in the LEVEL trial. Chris Giordano, the President and Chief Executive Officer of Tenax Therapeutics, expressed satisfaction with the outcomes of collaborative discussions with the FDA. Giordano emphasized the clarity provided by the FDA’s feedback, establishing a definitive pathway for commencing LEVEL, including mutual agreement on the primary efficacy endpoint and anticipated patient enrollment.

Giordano highlighted a pivotal aspect of the regulatory approval, stating, “Importantly, Tenax will not be required to conduct a long-term, cardiovascular outcomes trial, which should significantly reduce our costs and time to registration for TNX-103.” This strategic advantage is expected to expedite the drug’s journey to market, potentially benefitting patients sooner than traditional timelines.

With no existing approved therapies for PH-HFpEF in the United States, the LEVEL Study holds particular significance. Physicians, patients, and regulators alike increasingly recognize the substantial unmet need faced by patients grappling with PH-HFpEF.

Addressing this critical therapeutic gap, 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, commented, “Despite many therapeutic advancements across a wide spectrum of cardiovascular diseases, there are no FDA-approved treatments for PH-HFpEF, a condition impacting millions globally.” Dr. Shah expressed his satisfaction at leading the pivotal trial, emphasizing its potential to advance understanding and treatment options for PH-HFpEF through the investigation of TNX-103 and its novel approach in mitigating central and venous blood pressures associated with the condition.

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