Why Aeglea BioTherapeutics (AGLE) Shares Are Trading Higher Today

The European Medicines Agency (EMA) has validated Aeglea BioTherapeutics Inc's AGLE marketing application seeking approval for pegzilarginase for the treatment of Arginase 1 Deficiency (ARG1-D).
Arginase deficiency is an inherited disorder that causes the amino acid arginine (a building block of proteins) and ammonia to accumulate gradually in the blood.
Ammonia, formed when proteins are broken down in the body, is toxic if levels become too high.
Related: Aeglea BioTherapeutics Shares Plummet Following Refusal To File Letter From FDA.
Patients experience severe spasticity-related mobility limitations, seizures, developmental delay, intellectual disability, and early mortality.
The application was submitted by Immedica Pharma AB, Aeglea's commercialization partner in Europe and the Middle East.
The EMA has granted pegzilarginase orphan drug designation.
Immedica's submission includes data from multiple clinical studies, including the PEACE Phase 3 study and its ongoing long-term extension, a Phase 1/2 trial, and an open-label extension study.
Results showed that pegzilarginase could rapidly and sustainably lower arginine levels and improve mobility.
In the PEACE study, most treatment-emergent adverse events were mild or moderate, and there were no discontinuations due to treatment-emergent adverse events.
Price Action: AGLE shares are up 72.71% at $0.87 during the premarket session on the last check Friday.

Read Why Aeglea BioTherapeutics Shares Are Skyrocketing Today?