$XFOR (X4 PHARMACEUTICALS) — 8-K: FDA agrees to cut 4WARD Phase 3 trial size to 126 patients

X4 Pharmaceuticals announced a positive FDA Type C meeting outcome for the 4WARD Phase 3 trial of mavorixafor in chronic neutropenia. The FDA agreed that reducing the sample size from 176 to 126 participants maintains adequate power for the co-primary endpoints of reduction in annualized infection rate and positive ANC response. The FDA also indicated the proposed safety database would be acceptable to support a potential sNDA. X4 expects to complete enrollment by year-end 2026 and report topline data in H1 2028.

X4 Pharmaceuticals announced a positive FDA Type C meeting outcome for the 4WARD Phase 3 trial of mavorixafor in chronic neutropenia. The FDA agreed that reducing the sample size from 176 to 126 parti