Read Why Aeglea BioTherapeutics Shares Are Skyrocketing Today?

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  • 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.
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