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GlobeNewswire·

X4 Pharmaceuticals Announces Positive Outcome from FDA Type C Meeting

XFOR
  • FDA agreed to reduce the 4WARD Phase 3 trial sample size for mavorixafor from 176 to 126 participants while maintaining adequate statistical power.
  • The revised trial design retains co-primary endpoints of reduced annualized infection rate & positive absolute neutrophil count (ANC) response.
  • X4 Pharmaceuticals expects to complete enrollment for the 4WARD trial by the end of 2026.
  • Topline data from the trial is projected to be reported in the first half of 2028.
  • The FDA indicated the proposed safety database will be acceptable to support a supplemental new drug application (sNDA).
  • The 4WARD trial is a 52-week, randomized, double-blind, placebo-controlled study evaluating mavorixafor in patients aged 12 & older with chronic neutropenia.
  • Mavorixafor is an oral CXCR4 antagonist currently approved in the U.S. as XOLREMDI® & has received Fast Track designation for chronic neutropenia.