FDA accepts X4's NDA for mavorixafor with Priority Review; PDUFA April 30, 2024

X4 Pharmaceuticals, Inc

FDA accepted NDA for once-daily oral mavorixafor in WHIM syndrome (ages 12+) with Priority Review.
PDUFA target action date set for April 30, 2024; six-month review timeline.
If approved, X4 eligible for Priority Review Voucher due to rare pediatric disease designation.
NDA supported by Phase 3 4WHIM trial meeting primary endpoint (TAT-ANC p<0.0001) and reducing infections.
No approved therapies for WHIM syndrome; mavorixafor has Breakthrough Therapy, Fast Track, and Orphan status.

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