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Aeglea BioTherapeutics Up 5% After It Submits BLA For Pegzilarginase To Treat Arginase 1 Deficiency

Shares of Aeglea BioTherapeutics, Inc. (AGLE) are gaining over 5% on Tuesday morning after the clinical-stage biotechnology company said it has submitted a Biologics License Application to the FDA for pegzilarginase to treat Arginase 1 Deficiency or ARG1-D.

AGLE is currently trading at $2.56, up $0.13 or 5.3498%, on the Nasdaq. The stock opened its trading at $2.67 after closing previous day's trading at $2.43. The stock has traded between $1.80 and $8.68 in the past 52 week period.

Aeglea requested FDA Priority Review at the time of the BLA submission. If approved, pegzilarginase would be the first FDA-approved treatment for ARG1-D, a rare, progressive disease characterized by high levels of arginine.

Immedica Pharma AB, Aeglea's commercialization partner for pegzilarginase in certain countries in Europe and the Middle East, plans to submit the Marketing Authorization Application or MAA to the European Medicines Agency in 2022.

People living with ARG1-D experience severe spasticity-related mobility limitations, seizures, developmental delay, intellectual disability, and early mortality.

Pegzilarginase is a novel, recombinant human arginase 1 enzyme. In clinical trials, it has been shown to normalize the elevated levels of the amino acid arginine in patients with ARG1-D.

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