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Announces Completion of Dosing in Phase 1 Trial of AER-901 (inhaled imatinib), a Critical Milestone Toward the Planned Initiation of a Phase 2 Trial in Pulmonary Arterial Hypertension (PAH) During the First Half of 2023","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Aerami Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aerami Therapeutics Announces Expansion of the AER-901 (inhaled imatinib) Development Program in Pulmonary Hypertension Supported by Phase 1 Clinical Trial Data and Continued Progress","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small 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2023","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Aerovate Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aerovate: 24-Week Results from Phase 2b IMPAHCT for Pulmonary Arterial Hypertension","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2024","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase III"}]

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            Development Status

            Details:

            Aerami will be responsible for the overall development and commercialisation of inhaled imatinib, with Vectura providing development services expertise and a license to its FOX® mesh nebuliser technology.

            Lead Product(s): Imatinib Mesylate

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Aerami

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement June 08, 2020

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            Details:

            AV-101 (imatinib) is a novel dry powder inhaled formulation which inhibits the BCR-ABL tyrosine kinase. It is being evaluated for the treatment of pulmonary arterial hypertension.

            Lead Product(s): Imatinib Mesylate

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: AV-101

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 17, 2024

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            Details:

            AV-101 (imatinib) is a novel dry powder inhaled formulation which is being evaluated for the treatment of pulmonary arterial hypertension. It is a protein-tyrosine kinase inhibitor that inhibits the bcr-abl tyrosine kinase.

            Lead Product(s): Imatinib Mesylate

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: AV-101

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 20, 2023

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            Details:

            AER-901 (imatinib mesylate) is a tyrosine kinase inhibitor of PDGFR α and β kinases, Abl, DDR, and c-KIT may therefore prove efficacious in the treatment of pulmonary arterial hypertension.

            Lead Product(s): Imatinib Mesylate

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: AER-901

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 24, 2023

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            Details:

            AER-901 (imatinib mesylate) is a tyrosine kinase inhibitor of PDGFR α and β kinases, Abl, DDR, and c-KIT may therefore prove efficacious in the treatment of pulmonary arterial hypertension.

            Lead Product(s): Imatinib Mesylate

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: AER-901

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 03, 2023

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            Details:

            AER-901 (imatinib mesylate) is a tyrosine kinase inhibitor of PDGFR α and β kinases, Abl, DDR, and c-KIT may therefore prove efficacious in the treatment of pulmonary arterial hypertension.

            Lead Product(s): Imatinib Mesylate

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: AER-901

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 23, 2023

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            Details:

            The Company intends to use the net proceeds to progress the clinical development of TNX-201 (imatinib) for the treatment of PAH and levosimendan for the treatment of PH-HFpEF, toward regulatory approval for the treatment of these and potentially other indications.

            Lead Product(s): Imatinib Mesylate

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: TNX-201

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Roth Capital Partners

            Deal Size: $15.6 million Upfront Cash: Undisclosed

            Deal Type: Public Offering February 03, 2023

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            Details:

            AER-901 is a drug-device combination that is designed to deliver potentially reverse-remodeling therapy with imatinib mesylate deeply and efficiently throughout the diseased tissue of the lung via the FOX® nebulizer.

            Lead Product(s): Imatinib Mesylate

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: AER-901

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 21, 2022

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            Details:

            AV-101 is an investigational, proprietary dry powder inhaled formulation of the anti-proliferative drug imatinib. Developed specifically for PAH, AV-101 is designed for delivery by an easy-to-use dry powder inhaler, directly into the lungs.

            Lead Product(s): Imatinib Mesylate

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: AV-101

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 17, 2022

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            Details:

            TNX-201 (imatinib), a novel, oral, modified release formulation, a kinase inhibitor that has received FDA’s orphan designation for the treatment of pulmonary arterial hypertension (PAH).

            Lead Product(s): Imatinib Mesylate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: TNX-201

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 25, 2022

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