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Mezzion Pharmaceuticals is a rare disease company conducting the confirmatory pivotal phase 3 clinical trial in Fontan subjects: The Fontan Udenafil Exercise Longitudinal Assessment Trial- 2, or FUEL-2 trial.

Mezzion Pharma (“Mezzion”) announced that it has secured nearly $40M USD to fund FUEL-2, their confirmatory phase 3 clinical trial, along with future commercialization and regulatory submissions in other countries including Europe.

Mezzion Pharma Co., Ltd. (Mezzion Pharma) has submitted a confirmatory pivotal Phase 3 Clinical Trial in Fontan subjects to the Food and Drug Administration (FDA).

Mezzion Pharma Co., Ltd. (Mezzion Pharma) met with the FDA Division of Cardiology and Nephrology (DCN) on Friday, May 27th to discuss with the FDA the path forward for the regulatory approval of udenafil for the treatment of single ventricle heart disease (SVHD) in children with Fontan physiology.

Mezzion Pharma Co., Ltd., and Mezzion Pharmaceuticals, Inc., a leader in the field of rare single ventricle congenital heart disease and SVHD patients with Fontan circulation, is pleased to announce that Bill Breitenbach has joined Mezzion as the Chief Commercial Officer effective June 1st, 2021.

Mezzion Pharma Co., Ltd. (Mezzion Pharma) announces that new data from its Phase 3 efficacy and safety trial (FUEL Trial) and its open label extension trial (FUEL OLE Trial) that concerns the treatment of a very large subgroup of patients with congenital single ventricle heart disease (SVHD) who have Fontan physiology was presented to the U.S. Food and Drug Administration (FDA) in a Type C meeting held on Thursday, December 16, 2021.

Mezzion Pharma Co., Ltd. (140410.KQ) is pleased to announce today that it has received notice from the FDA that its NDA submitted on March 26, 2021 for the use of udenafil to treat SVHD patients who have undergone Fontan palliation is sufficiently complete to permit a substantive review (the “FDA Notice”).

Mezzion Pharma Co. Ltd., announced that it has re-submitted a New Drug Application to the U.S. Food and Drug Administration for the approval of udenafil to improve the exercise capacity of patients 12 years of age and older with single ventricle heart disease who have undergone the Fontan operation.

Mezzion Pharma Co. Ltd. announces the presentation of data from its pivotal clinical trial for its new orphan drug for the treatment of adolescents with single ventricle heart disease.

The purpose of the Type C meeting was to receive FDA guidance on Mezzion’s NDA submission.