X4 Pharma submits NDA to FDA for mavorixafor in WHIM syndrome

X4 Pharmaceuticals, Inc

Submission supported by positive Phase 3 4WHIM trial results; met primary and key secondary endpoints.
Requested priority review; if granted, FDA review period would be six months from acceptance.
Mavorixafor is an oral once-daily candidate for WHIM syndrome, a rare primary immunodeficiency in patients 12+.
No treatment-related serious adverse events or discontinuations for safety in the Phase 3 trial.
CEO Paula Ragan calls it a significant milestone; could be first approved U.S. product for WHIM syndrome.

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