Tuesday, December 23, 2025
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Imugene: Receives clinical guidance from U.S. FDA for VAXinia

  • Imugene has received guidance from the U.S. Food and Drug Administration (FDA) for the development of VAXinia
  • The FDA provided guidance on a development plan for a phase one study design as well as feedback on part two of the study
  • VAXinia is an oncolytic virotherapy drug that is being developed to treat various cancers
  • Given the uncertainty during the COVID-19 pandemic, Imugene considers it important to be flexible with identifying regulatory pathways
  • Imugene is also seeking a regulatory pathway in Australia
  • Company shares are up 2.68 per cent and are trading for 5.8 cents

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