Menarini Receives FDA Orphan Drug Designation for SEL24/MEN1703, a first in class, dual PIM/FLT3 inhibitor for the Treatment of Acute Myeloid Leukemia

Florence (Italy) November 4th, 2021 – The Menarini Group announced today that the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to SEL24/MEN1703 for the treatment of Acute Myeloid Leukemia (AML). SEL24/MEN1703 is a first-in-class, orally available, dual PIM/FLT3 inhibitor, in-licensed by Menarini from Ryvu Therapeutics, and currently investigated in the DIAMOND-01 trial as a single agent for the treatment of patients with relapsed/refractory AML.

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