regulatory
confidence high
sentiment positive
materiality 0.65
FDA agrees to X4's reduced 4WARD trial sample size (176 to 126); topline data expected H1 2028
X4 Pharmaceuticals, Inc
- FDA agreed to cut 4WARD Phase 3 sample size from 176 to 126 patients, preserving power for co-primary endpoints.
- Safety database deemed acceptable to support potential sNDA for mavorixafor in chronic neutropenia.
- Enrollment of 4WARD expected to complete by end of 2026; topline data in H1 2028.
- Mavorixafor targets ~15,000 patients with serious/recurring infections due to chronic neutropenia.