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Radiopharm Theranostics - FDA grants rare pediatric disease designation for DUNP19


-- Further recognition of DUNP19’s potential in a rare disease impacting children
-- The RPD designation allows companies to receive a priority review voucher (at the time of marketing authorization) that can expedite approval or be transferred/sold to another company
-- Follows Oprhan Drug Designation announced 9 September 2022
-- 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 Rare Pediatric Disease (RPD) Designation for its DUNP19 technology for the treatment of osteosarcoma.

The RPD program is aimed at advancing development of drugs with the potential to treat serious, rare pediatric diseases.

For more information, download the attached PDF.

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