earnings
confidence high
sentiment positive
materiality 0.75
X4 Pharma: NDA accepted for mavorixafor in WHIM with PDUFA April 30, 2024; Q3 net loss $2.3M
X4 Pharmaceuticals, Inc
2023-Q3 EPS reported
-$0.48
- FDA accepted NDA for once-daily oral mavorixafor in WHIM syndrome with Priority Review; PDUFA target April 30, 2024; eligible for Priority Review Voucher if approved.
- Ongoing Phase 2 chronic neutropenia data to be presented at ASH Dec 9-12, 2023; Phase 3 trial initiation expected 1H 2024.
- Q3 2023 cash, equivalents, and marketable securities totaled $142.7M; net loss of $2.3M (incl. $25.2M non-cash gain vs. $21.6M net loss in Q3 2022).
- Completed $115M debt facility with Hercules Capital; initial draw of $22.5M in August 2023.
- Appointed Christophe Arbet-Engels, MD, PhD as Chief Medical Officer in August 2023; added R. Keith Woods to Board of Directors in October 2023.