X4 Pharmaceuticals: FDA To Review Mavorixafor NDA In WHIM Syndrome

(RTTNews) - X4 Pharmaceuticals (XFOR) said the FDA has accepted for filing the company's New Drug Application for once-daily, oral mavorixafor to treat individuals aged 12 and older with Warts, Hypogammaglobulinemia, Infections, and Myelokathexis syndrome. The FDA granted Priority Review of the mavorixafor NDA, assigning a PDUFA target action date of April 30, 2024.

The company said its NDA is supported by the results of the global, pivotal, 4WHIM Phase 3 clinical trial of once-daily, oral mavorixafor in individuals with WHIM syndrome.

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