X4 Pharmaceuticals announces EMA validation of MAA for mavorixafor

X4 Pharmaceuticals (XFOR) announced that its Marketing Authorization Application for mavorixafor for the treatment of WHIM syndrome, a rare primary immunodeficiency, has been validated for review and is now under evaluation with the European Medicines Agency’s Committee for Medicinal Products for Human Use. The EMA previously granted orphan designation to mavorixafor in WHIM syndrome. In April 2024, mavorixafor received U.S. Food and Drug Administration approval as XOLREMDI, an oral, once-daily treatment for use in patients 12 years of age and older with WHIM syndrome to increase the number of circulating mature neutrophils and lymphocytes.