Regulatory Environment

Orphan Drug Designation (ODD)

  • US Food and Drug Administration (FDA) granted ODD to Veyonda for soft tissue sarcoma – early 2022
    • Supports Veyonda’s development in sarcoma via the CEP-2 trial
  • Only four Australian companies received ODD approval in 2021

Regulatory trial approvals 

  • US FDA Investigational New Drug (IND) granted for Veyonda in combination with doxorubicin for the treatment of sarcoma – CEP-2 trial
  • US FDA IND granted for investigation of Veyonda in prostate cancer – DARRT-2 trial
  • Approvals followed regulatory evaluation of significant Veyonda data packages
  • Enabled CEP-2 and DARRT-2 trials to take place in these important commercial territories
  • Trial sites in Australia, the United States and Europe