Akeso Inc.'s Ligufalimab Receives FDA Orphan Drug Designation for Acute Myeloid Leukemia Treatment

Reuters
2025.09.16 02:28
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Akeso Inc. has received Orphan Drug Designation from the U.S. FDA for its monoclonal antibody, ligufalimab (AK117), aimed at treating acute myeloid leukemia (AML). This designation offers benefits like FDA guidance, tax incentives, and potential market exclusivity for up to seven years. Akeso is progressing with clinical trials for ligufalimab in hematologic malignancies and solid tumors, showing promising results.