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Ligufalimab granted orphan drug designation by the FDA for the treatment of AML
On September 15, 2025, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to ligufalimab for the treatment of patients with acute myeloid leukemia (AML). Ligufalimab is a next-generation humanized IgG4 monoclonal antibody that targets CD47, blocking its interaction with the SIRPα receptor.
Ligufalimab has demonstrated promising efficacy and a favorable safety profile in combination with azacitidine in a phase Ib/II trial (NCT04980885) for the treatment of patients with AML. Ligufalimab is also under investigation in an ongoing phase II trial for the treatment of high-risk myelodysplastic syndromes (NCT06196203), and in phase III studies for the treatment of pancreatic cancer (NCT06953999) and PD-L1-positive head and neck squamous cell carcinoma (NCT06601335).
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