X4 Pharmaceuticals, Inc. (XFOR) on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for mavorixafor for the treatment of WHIM syndrome, a rare congenital immunodeficiency disorder.
A decision from the European Commission is anticipated in the second quarter of 2026.
The opinion was supported by positive results from a pivotal Phase 3 trial evaluating the efficacy and safety of XOLREMDI in patients aged 12 years and older with WHIM syndrome.
In January 2025, X4 had entered into a licensing and supply agreement with Norgine under which Norgine will commercialize mavorixafor in Europe, Australia and New Zealand following regulatory approvals. X4 is eligible to receive up to $226 million tied to regulatory and commercial milestones, along with escalating double-digit royalties of up to the mid-twenties percentage on future net sales in the licensed territories.
On Thursday, X4 Pharma shares closed at $3.25, down 5.52%.
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