Levosimendan

Tenax Therapeutics Provides Business and Clinical Development Updates with Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
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We also made important progress in further expanding levosimendan’s U.S. intellectual property protections, securing the future commercial value of TNX-103.

Key Points: 
  • We also made important progress in further expanding levosimendan’s U.S. intellectual property protections, securing the future commercial value of TNX-103.
  • In February 2024, Tenax Therapeutics announced that the first patient had enrolled in the Phase 3 LEVEL Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients) ( NCT05983250 ).
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    Tenax Therapeutics reported cash and cash equivalents of $9.8 million as of December 31, 2023.
  • Tenax Therapeutics reported a net loss for 2023 of $7.7 million, compared to a net loss of $11.0 million in 2022.

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)

Retrieved on: 
Thursday, February 8, 2024
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CHAPEL HILL, N.C., Feb. 07, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that the first patient has enrolled in the Company’s Phase 3 LEVEL Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients) (NCT05983250).

Key Points: 
  • “The Tenax team and our CRO and other research partners have worked tirelessly to reach this milestone.
  • We believe this positions Tenax, and potential strategic partners, to maximize the commercial potential of this unique, first-in-class therapy.
  • “Nine of the ten investigators who randomized patients in our previous levosimendan study – at sites like Mayo, Harvard, Northwestern – have agreed to enroll patients in LEVEL.
  • The LEVEL study will evaluate six-minute walking distance (6MWD) as the primary endpoint, and will enroll a total of 152 patients.

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

Retrieved on: 
Monday, November 13, 2023
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The LEVEL Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients) is expected to launch in the fourth quarter of 2023.

Key Points: 
  • The LEVEL Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients) is expected to launch in the fourth quarter of 2023.
  • “We could not be more pleased with the results of our collaborative, productive discussions with the FDA, which provide a clear path to starting LEVEL, including mutual alignment with respect to the primary efficacy endpoint and expected patient enrollment,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics.
  • “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.
  • Every investigative site that enrolled patients in the HELP Study has been invited to participate in LEVEL, and already 90% have agreed to take part.

Tenax Announces Issuance of U.S. Patent Covering Use of IV Levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

Retrieved on: 
Wednesday, March 22, 2023
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11,607,412 is titled “Levosimendan For Treating Pulmonary Hypertension With Heart Failure With Preserved Ejection Fraction (PH-HFpEF).”

Key Points: 
  • 11,607,412 is titled “Levosimendan For Treating Pulmonary Hypertension With Heart Failure With Preserved Ejection Fraction (PH-HFpEF).”
    The patent term expires December 2040 and provides the Company substantial added intellectual property (IP) protection for the use of levosimendan.
  • The newly issued patent expands upon the Company’s existing IP for levosimendan, which includes U.S. Patent No.
  • 11,213,524, issued in January 2022, covering all medical uses of the subcutaneous formulation of levosimendan in humans.
  • Chris Giordano, Tenax Therapeutics’ President and Chief Executive Officer, stated, “Tenax is building a solid patent estate surrounding levosimendan.

Tenax Granted Notice of Allowance for U.S. Patent Application Covering Use of IV Levosimendan in Pulmonary Hypertension with Heart Failure and Preserved Ejection Fraction (PH-HFpEF)

Retrieved on: 
Wednesday, February 1, 2023
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This Notice of Allowance further builds upon the Company’s significant IP for levosimendan, which includes U.S. Patent No.

Key Points: 
  • This Notice of Allowance further builds upon the Company’s significant IP for levosimendan, which includes U.S. Patent No.
  • 11,213,524 that was issued in January 2022 and covers all medical uses in humans of the subcutaneous formulation of levosimendan.
  • When transitioning to the oral daily formulation after a lengthy treatment with the weekly IV formulation, the 6-minute walk results improved further.
  • "Elucidating the Clinical Implications and Pathophysiology of Pulmonary Hypertension in Heart Failure With Preserved Ejection Fraction: A Call to Action: A Science Advisory From the American Heart Association."

Positive Data Presented at HFSA Annual Meeting Demonstrate Effects of Oral Levosimendan in Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

Retrieved on: 
Monday, October 10, 2022
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Author: Thenappan Thenappan, MD Associate Professor of Medicine and Section Leader, Pulmonary Hypertension Program at the University of Minnesota, et al.

Key Points: 
  • Author: Thenappan Thenappan, MD Associate Professor of Medicine and Section Leader, Pulmonary Hypertension Program at the University of Minnesota, et al.
  • This substudy of 18 PH-HFpEF patients who transitioned from IV to oral levosimendan, included an evaluation of safety and efficacy across several measures.
  • The mean Kansas City Cardiomyopathy Questionnaire scores (KCCQ-TS, KCCQ-CS and KCCQ-OS) (n=16) improved by 4.7, 2.5 points and 3.7 points, respectively.
  • We are very encouraged to see these effects in patients who have received levosimendan therapy for over two years.

Tenax Therapeutics Announces the Evaluation of Strategic Alternatives

Retrieved on: 
Thursday, September 15, 2022
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Roth Capital Partners will support Tenax Therapeutics as its financial advisor in this process.

Key Points: 
  • Roth Capital Partners will support Tenax Therapeutics as its financial advisor in this process.
  • Tenax Therapeutics and its Board of Directors believe the current valuation of the Company does not accurately reflect the potential value of its clinical-stage pipeline.
  • The Company will therefore explore a diverse range of strategic options to help drive shareholder value including, among other things, a sale, merger, or other strategic transaction.
  • Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law.

Tenax Therapeutics Announces Successful Comparative Pharmacokinetic Study of TNX-201 for the Treatment of Pulmonary Arterial Hypertension

Retrieved on: 
Monday, May 23, 2022
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Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced the successful completion of its comparative pharmacokinetic study of TNX-201, for the treatment of pulmonary arterial hypertension (PAH).

Key Points: 
  • Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced the successful completion of its comparative pharmacokinetic study of TNX-201, for the treatment of pulmonary arterial hypertension (PAH).
  • Based on these positive pharmacokinetic findings, Tenax Therapeutics and its formulation partner are now manufacturing TNX-201 at the target scale for both the Phase 3 trial and future market demand.
  • Tenax Therapeutics is developing novel dosing and a unique formulation of imatinib mesylate, a kinase inhibitor that has received FDAs orphan designation (March 2020) for the treatment of pulmonary arterial hypertension (PAH).
  • Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law.

Tenax Therapeutics Announces $8 Million PIPE Offering Priced At-the-Market under Nasdaq Rules

Retrieved on: 
Wednesday, May 18, 2022
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The offering is expected to close on or about May 19, 2022, subject to the satisfaction of customary closing conditions.

Key Points: 
  • The offering is expected to close on or about May 19, 2022, subject to the satisfaction of customary closing conditions.
  • The aggregate gross proceeds to the Company of the offering are expected to be approximately $8 million.
  • Tenax Therapeutics has North American rights to develop and commercialize oral (TNX-103) and subcutaneous (TNX-102) formulations of levosimendan.
  • Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law.

Tenax Therapeutics Reports Fiscal Year 2021 Results and Provides Business Update

Retrieved on: 
Thursday, March 31, 2022
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On January 12, announced that the United States Patent and Trademark Office (USPTO) granted Tenax a patent (No.

Key Points: 
  • On January 12, announced that the United States Patent and Trademark Office (USPTO) granted Tenax a patent (No.
  • In January 2021, Tenax purchased PHPrecisionMed Inc., a clinical stage biotechnology company focused on pulmonary hypertension, reflected in the operating results for the year ended December 31, 2021.
  • Tenax Therapeutics has North American rights to develop and commercialize oral (TNX-103) and subcutaneous (TNX-102) formulations of levosimendan.
  • Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law.