AGLE - Aeglea stock soars 24% on filing seeking FDA approval of pegzilarginase for rare disorder

Aeglea BioTherapeutics (NASDAQ:AGLE) submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval of pegzilarginase to treat Arginase 1 Deficiency (ARG1-D). The company has requested FDA priority review of the biologics license application (BLA). Aeglea (AGLE) added that if approved, pegzilarginase would be the first FDA-approved treatment for ARG1-D. ARG1-D is rare inherited disorder characterized by lack or less of the enzyme arginase — which plays a role in the breakdown and removal of nitrogen from the body — in the liver and red blood cells. This lack of arginase leads to elevated levels of the amino acid arginine in patients with ARG1-D. Symptoms include mobility limitations, seizures, developmental delay and intellectual disability, among others. The company said that in trials, pegzilarginase, a recombinant human arginase 1 enzyme, has shown to normalize the elevated levels of the amino acid arginine in patients with ARG1-D. The submission was backed by data from

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Aeglea stock soars 24% on filing seeking FDA approval of pegzilarginase for rare disorder