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Details:

Amendment to the existing agreement gives Tenax rights to develop and commercialize in the United States and Canada an oral formulation of levosimendan for use with Type 2 pulmonary hypertension in heart failure patients with PH-HFpEF, or other heart related indications.


Lead Product(s): Levosimendan

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Tenax Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement October 15, 2020

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Details:

Under the license agreement, Tenax will be developing and commercializing the TNX-103 (levosimendan) for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction.


Lead Product(s): Levosimendan

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TNX-103

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Orion Corporation

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement February 20, 2024

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Details:

The company intends to use the net proceeds for the clinical development of TNX-103 (levosimendan) for the treatment of pulmonary hypertension and heart failure with preserved ejection fraction.


Lead Product(s): Levosimendan

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: TNX-103

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Roth Capital Partners

Deal Size: $9.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering February 08, 2024

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Details:

TNX-103 (levosimendan) is a potassium ATP channel activator and calcium sensitizer that affects the heart & vascular system. It is being evaluated in phase 3 trials for the treatment of pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF).


Lead Product(s): Levosimendan

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: TNX-103

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 07, 2024

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Details:

TNX-103 (levosimendan), is an oral, small molecule, unique potassium ATP channel activator and calcium sensitizer, being developed for Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction. There are currently no FDA approved treatments for PH-HFpEF.


Lead Product(s): Levosimendan

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TNX-103

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 13, 2023

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Details:

TNX-103 (levosimendan), is an oral, small molecule, unique potassium ATP channel activator and calcium sensitizer, being developed for Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction. There are currently no FDA approved treatments for PH-HFpEF.


Lead Product(s): Levosimendan

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TNX-103

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 31, 2023

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TNX-101 (levosimendan) is a unique potassium ATP channel activator and calcium sensitizer that affects the heart and vascular system through multiple mechanisms of action.


Lead Product(s): Levosimendan

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: TNX-101

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 22, 2023

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Details:

TNX-101 (levosimendan) is a unique potassium ATP channel activator and calcium sensitizer that affects the heart and vascular system through multiple mechanisms of action.


Lead Product(s): Levosimendan

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: TNX-101

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 01, 2023

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Details:

Levosimendan (TNX-102 and TNX-103) is a unique potassium ATP channel activator and calcium sensitizer that affects the heart and vascular system through multiple mechanisms of action.


Lead Product(s): Levosimendan

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TNX-102

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Orion Corporation

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 10, 2022

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Details:

USPTO granted patent forTNX-102 (levosimendan), on the basis of results from the study that led to the discovery and work as a potassium-ATP channel activator in reducing the elevated central venous and pulmonary venous pressures in PH-HFpEF patients.


Lead Product(s): Levosimendan

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TNX-102

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 12, 2022

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Details:

Phase 2 trial of TNX-102 (levosimendan) in patient with pulmonary hypertension and heart failure, demonstrated that it produces potent dilation of the central and pulmonary venous circulations which translated into an improvement in exercise capacity.


Lead Product(s): Levosimendan

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TNX-102

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 04, 2022

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Details:

The phase 2 HELP Study enrolled patients with pulmonary hypertension and heart failure with preserved ejection fraction and was designed to evaluate levosimendan’s hemodynamic and clinical effects during rest and exercise.


Lead Product(s): Levosimendan

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 10, 2020

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Details:

The HELP Study was a multi-center, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate levosimendan in 36 patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF).


Lead Product(s): Levosimendan

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 02, 2020

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Phase 2 HELP Study of levosimendan in PH-HFpEF have been accepted for presentation as a Late-Breaking Clinical Trial at this year’s Heart Failure Society of America (HFSA) Annual Scientific Meeting to be held September 30, 2020-October 6, 2020.


Lead Product(s): Levosimendan

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 31, 2020

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Details:

The primary endpoint of the trial was to show a statistically significant difference between levosimendan and placebo in slow vital capacity (SVC) in supine position at 12 weeks compared to the baseline.


Lead Product(s): Levosimendan

Therapeutic Area: Neurology Product Name: ODM-109

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 28, 2020

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Details:

Tenax currently intends to use the net proceeds from the offerings to further its clinical trials of levosimendan, for research and development and general corporate purposes, including working capital and potential acquisitions.


Lead Product(s): Levosimendan

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: H.C. Wainwright & Co

Deal Size: $8.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering July 06, 2020

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Details:

Levosimendan demonstrated a statistically significant reduction in PCWP compared to baseline and placebo when the measurements at rest, with legs up and on exercise were combined.


Lead Product(s): Levosimendan

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 02, 2020

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Details:

Last patient has completed their final visit in the Company’s Phase 2 clinical trial of levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction.


Lead Product(s): Levosimendan

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 09, 2020

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Details:

Tenax currently intends to use the net proceeds from the offering to further its clinical trials of levosimendan, for research and development and general corporate purposes.


Lead Product(s): Levosimendan

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: H.C. Wainwright & Co

Deal Size: $2.8 million Upfront Cash: Undisclosed

Deal Type: Public Offering March 12, 2020

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Details:

Tenax Therapeutics reports that till now 24 patients have been randomized, pulmonary capillary wedge pressure was reduced and no serious drug-related adverse events have been reported to date.


Lead Product(s): Levosimendan

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 13, 2020

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