secwatch.observer — SEC 8-K summary
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Issuer:     X4 Pharmaceuticals, Inc (XFOR)
CIK:        0001501697
Form:       8-K
Filed at:   2026-09-08T11:15:54+00:00
Accession:  0001501697-26-000072
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA agrees to X4's reduced 4WARD trial sample size (176 to 126); topline data expected H1 2028
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- FDA agreed to cut 4WARD Phase 3 sample size from 176 to 126 patients, preserving power for co-primary endpoints.
- Safety database deemed acceptable to support potential sNDA for mavorixafor in chronic neutropenia.
- Enrollment of 4WARD expected to complete by end of 2026; topline data in H1 2028.
- Mavorixafor targets ~15,000 patients with serious/recurring infections due to chronic neutropenia.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1501697/000150169726000072/0001501697-26-000072-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1501697/000150169726000072/xfor-20260908.htm
  HTML page:      https://secwatch.observer/filing/0001501697-26-000072

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