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[{"orgOrder":0,"company":"Mezzion Pharma Co Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mezzion Pharma's Udenafil Improved Ventricular Function Measured by Myocardial Performance Index in adolescents with SVHD","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Mezzion Pharma Co Ltd"},{"orgOrder":0,"company":"Mezzion Pharma Co Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mezzion Announces Submission of NDA for its Orphan Drug Udenafil","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Mezzion Pharma Co Ltd"},{"orgOrder":0,"company":"Mezzion Pharma Co Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mezzion's NDA for its Orphan Drug Udenafil for Single Ventricle Heart Disease (\"SVHD\") has been Accepted for Filing by the FDA","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Mezzion Pharma Co Ltd"},{"orgOrder":0,"company":"Mezzion Pharma Co Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mezzion Pharma Receives Clear FDA Path Forward for the Approval of Udenafil for Single Ventricle Heart Disease","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Mezzion Pharma Co Ltd"},{"orgOrder":0,"company":"Mezzion Pharma Co Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mezzion Pharma Submits Protocol for Confirmatory Pivotal Phase 3 Trial (\"FUEL-2\") in Fontan Subjects","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Mezzion Pharma Co Ltd"},{"orgOrder":0,"company":"Mezzion Pharma Co Ltd","sponsor":"BRV Capital Management","pharmaFlowCategory":"D","amount":"$40.0 million","upfrontCash":"Undisclosed","newsHeadline":"Mezzion Pharma Raises Nearly $40M to Advance a First-to-Market Treatment Option for Fontan Patients","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Mezzion Pharma Co Ltd"}]

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            The financing will fund FUEL-2, Mezzion's confirmatory phase 3 trial, along with future commercialization and regulatory submissions in other countries including Europe. Mezzion is looking to market JURVIGO® (udenafil), a highly selective, unique and potent PDE-5 inhibitor.

            Lead Product(s): Udenafil

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: Jurvigo

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: BRV Capital Management

            Deal Size: $40.0 million Upfront Cash: Undisclosed

            Deal Type: Financing April 25, 2023

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            MZ101 (udenafil) is a phosphodiesterase type 5 inhibitor, improves measures of exercise performance at the ventilatory anaerobic threshold in individuals with fontan physiology.

            Lead Product(s): Udenafil

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: MZ101

            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 February 21, 2023

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            Mezzion sought clarity on the critical elements of an additional clinical trial that may be needed to complete the NDA submission for Udenafil for Single Ventricle Heart Disease.

            Lead Product(s): Udenafil

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

            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 31, 2022

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            The FDA had previously granted Mezzion's request to designate udenafil for treatment of single ventricle congenital heart disease as a drug for a Rare Pediatric Disease.

            Lead Product(s): Udenafil

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

            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, 2021

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            The NDA submission, which totals nearly 100,000 pages, is supported by data from more than 700 documents including more than 200 studies that Mezzion has completed during the last 2 decades since its founding in 2002.

            Lead Product(s): Udenafil

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

            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 30, 2020

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            Subjects on udenafil therapy showed a statistically significant improvement in ventricular performance as measured by MPI as compared to subjects taking placebo over the same time period.

            Lead Product(s): Udenafil

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

            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 18, 2020

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