2026-05-15
FDA Grant Orphan Drug Designation to BY002 for the Treatment of Acute Myeloid Leukemia (AML) with KMT2A Rearrangement or NPM1 Mutation
Shanghai, May 15, 2026 — Beyang Therapeutics Co., Ltd, a clinical-stage niopharmaceutical company pioneering next-generation targeted therapies for hematologic malignancies, today announced that the U.S. Food and Drug Administration (FDA) has granted Ophan Drug Designation (ODD) to BY002, an oral, otent, and highly selective next-generation menin inhibitor.