Aeglea Bio Feels FDA Refusal Pinch, Cuts Workforce, Shifts Pipeline Focus

  • Aeglea BioTherapeutics Inc AGLE announced a leadership transition and corporate restructuring to focus resources on AGLE-177 in development for Homocystinuria, an inherited disorder in which the body is unable to process certain building blocks of proteins (amino acids ) properly.
  • In June, the FDA issued a refusal-to-file letter for pegzilarginase for arginase 1 deficiency, asking for additional data to support the effectiveness of the therapy, such as proof that plasma arginine and metabolite reduction predict clinical benefit or other evidence of clinically meaningful outcomes. 
  • Also Read: Read Why Aeglea BioTherapeutics Shares Are Skyrocketing Today?
  • In the Q2 earnings update, Aeglea revealed that given the "current state of the financial markets," it had also begun to look at the allocation of resources to the program.
  • Aeglea has further reduced the headcount resulting in an approximately 25% reduction. 
  • The company also plans to realize additional cost savings by transitioning patients out of the ongoing extension studies of pegzilarginase in Arginase 1 Deficiency while it engages with the FDA on a regulatory path forward. 
  • The reallocation will extend the company's cash runway into Q4 of 2023. 
  • Aeglea CEO Anthony Quinn is among the people leaving the company. Quinn has stepped down from the position and immediately transitioned to an advisory role. Jim Kastenmayer, Aeglea's current general counsel, will serve as interim CEO.
  • Price Action: AGLE shares are down 12.50% at $0.60 on the last check Wednesday.
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