secwatch.observer — SEC 8-K summary
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Issuer:     X4 Pharmaceuticals, Inc (XFOR)
CIK:        0001501697
Form:       8-K
Filed at:   2023-10-31T23:59:59+00:00
Accession:  0001628280-23-035729
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1501697/000162828023035729/0001628280-23-035729-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1501697/000162828023035729/xfor-20231031.htm
  HTML page:      https://secwatch.observer/filing/0001628280-23-035729

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer