{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-23-035729","form_type":"8-K","ticker":"XFOR","cik":"0001501697","company_name":"X4 Pharmaceuticals, Inc","filed_at":"2023-10-31T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.282903+00:00","generated_at":"2026-06-09T04:34:09.954412+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA accepts X4's NDA for mavorixafor with Priority Review; PDUFA April 30, 2024","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-23-035729","json":"https://secwatch.observer/filing/0001628280-23-035729.json","markdown":"https://secwatch.observer/filing/0001628280-23-035729.md","text":"https://secwatch.observer/filing/0001628280-23-035729.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1501697/000162828023035729/0001628280-23-035729-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1501697/000162828023035729/xfor-20231031.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-09T04:34:09.954412+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}