AGLE - Aeglea BioTherapeutics receives FDA Refuse to File letter for pegzilarginase

The U.S. FDA has issued Aeglea BioTherapeutics (NASDAQ:AGLE) a Refuse to File letter for pegzilarginase for Arginase 1 Deficiency. The letter asks for more data to demonstrate efficacy as well as additional information related to chemistry manufacturing and controls. No safety concerns were brought up. Aeglea (AGLE) plans to request a Type A meeting with the FDA to address the concerns. Immedica Pharma AB, Aeglea's partner for pegzilarginase in Europe and the Middle East, plans to submit an application to the European Medicines Agency later this year. Seeking Alpha's Quant Rating views Aeglea as a strong sell.

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Aeglea BioTherapeutics receives FDA Refuse to File letter for pegzilarginase