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Radiopharm Theranostics - FDA grants Orphan drug status to RAD DUNP19 for Osteosarcoma


  • Excellent recognition of the potential of DUNP19 to treat a rare bone cancer
  • The FDA designation derives several benefits including tax breaks, user fee exemption and seven years market exclusivity post approval
  • RAD acquired the DUNP19 technology from UCLA in April 2022
  • Osteosarcoma has a significant unmet need with surgery and chemotherapy the current standard of care

Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a developer of a world-class platform of radiopharmaceutical products for both diagnostic and therapeutic uses, is pleased to announce that the US Food & Drug Administration (FDA) has granted Orphan Drug Designation for its DUNP19 technology for the treatment of osteosarcoma.

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