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Details:
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: BRV Capital Management
Deal Size: $40.0 million Upfront Cash: Undisclosed
Deal Type: Financing April 25, 2023
Details:
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 21, 2023
Details:
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2022
Details:
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2021
Details:
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2020
Details:
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 IIIProduct 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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