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Aptose's leukemia drug receives US FDA's orphan drug designation

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Aptose's leukemia drug receives US FDA's orphan drug designation

Aptose Biosciences Inc.'s CG'806 received the U.S. Food and Drug Administration's orphan drug designation to treat acute myeloid leukemia, a type of blood and bone marrow cancer.

CG'806 targets the FLT3 receptor which is one of the most frequently mutated genes in acute myeloid leukemia patients.

The FDA's orphan drug designation supports the development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S.

Orphan drug designation provides Aptose certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees and tax credits for qualified clinical trials.