Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE) announced the U.S. Food and Drug Administration (FDA) has refused to accept the company’s Biologics License Application (BLA) with a Refusal to File (RTF) letter.
The company filed the BLA in April for its lead drug candidate pegzilarginase for the treatment of Arginase 1 Deficiency (ARG1-D), based on positive results from PEACE Phase 3 study as well as a Phase 1/2 clinical trial and its open-label extension study.
