Mezzion Pharma Co. Ltd. announced 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 December 16, 2021. Mezzion Pharma reported that this newly presented data from the FUEL Trial is statistically significant and supports efficacy and clinical relevance for udenafil treatment of this very large subgroup, approximately 80% of the treatment population, who will most benefit from udenafil treatment. Mezzion Pharma is also pleased to report that the FUEL OLE Trial data supports and is believed to provide independent confirmatory evidence of reproducibility and durability of this efficacy for this very large subgroup.