XFOR X4 Pharmaceuticals

X4 Pharmaceuticals updates mavorixafor PCN Phase 3 4WARD full enrollment to Q4 2026 and topline to Q1 2028

The investor presentation states that full enrollment (N=126) in the ongoing pivotal Phase 3 4WARD trial of mavorixafor in primary chronic neutropenia is now expected by end of Q4 2026, with topline data expected in Q1 2028. A Phase 2b 4STEPS trial for G-CSF dose reduction is planned to initiate in Q1 2027 with topline in H1 2028. Potential US FDA approval is guided for late 2028/early 2029.

X4 Pharmaceuticals Secures up to $150M Debt Facility with K2 HealthVentures; Updates 4WARD Phase 3 Timeline

X4 entered a new senior secured loan facility of up to $150M with K2 HealthVentures, using the initial $80M tranche to repay its prior loan. The company now guides for completion of enrollment in the pivotal Phase 3 4WARD trial of mavorixafor in chronic neutropenia by year-end 2026 and topline data readout in H1 2028.

X4 Pharmaceuticals: FDA agrees to 4WARD Phase 3 sample-size reduction

FDA Type C meeting outcome allows reduction of 4WARD Phase 3 enrollment from 176 to 126 participants while preserving statistical power for co-primary endpoints. Company now guides completion of enrollment by year-end 2026 and topline data in H1 2028 to support a future sNDA.