11:19 AM EDT, 04/29/2024 (MT Newswires) -- X4 Pharmaceuticals ( XFOR ) said Monday that the US Food and Drug Administration has approved Xolremdi for use in patients 12 years and older with warts, hypogammaglobulinemia, infections and myelokathexis, or WHIM, syndrome to raise circulating mature neutrophils and lymphocytes.
The approval was based on results of a late-stage trial that showed Xolremdi improved absolute neutrophil and lymphocyte counts, with a reduction in infections, the company said.
X4 said it also received a rare pediatric disease priority review voucher from the FDA that can be used to obtain priority review for a subsequent application or sold to another drug sponsor.
Shares of the company were down more than 6% in recent trading.
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