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X4 Pharmaceuticals (XFOR) FDA Events

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FDA Events for X4 Pharmaceuticals (XFOR)

This section highlights FDA-related milestones and regulatory updates for drugs developed by X4 Pharmaceuticals (XFOR). Over the past two years, X4 Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Mavorixafor. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Mavorixafor - FDA Regulatory Timeline and Events

Mavorixafor is a drug developed by X4 Pharmaceuticals for the following indication: In people diagnosed with idiopathic, cyclic, or congenital neutropenia. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

X4 Pharmaceuticals FDA Events - Frequently Asked Questions

Yes, X4 Pharmaceuticals (XFOR) has received FDA approval for Mavorixafor. This page tracks recent and historical FDA regulatory events related to X4 Pharmaceuticals' drug portfolio.

In the past two years, X4 Pharmaceuticals (XFOR) has reported FDA regulatory activity for Mavorixafor.

The most recent FDA-related event for X4 Pharmaceuticals occurred on June 16, 2025, involving Mavorixafor. The update was categorized as "Presentation," with the company reporting: "X4 Pharmaceuticals announced the presentation of positive data from its completed Phase 2 trial of mavorixafor in the treatment of certain chronic neutropenic (CN) conditions at the 30th Annual Congress of the European Hematology Association (EHA) in Milan, Italy."

Currently, X4 Pharmaceuticals has one therapy (Mavorixafor) targeting the following condition: In people diagnosed with idiopathic, cyclic, or congenital neutropenia..

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:XFOR) was last updated on 7/10/2025 by MarketBeat.com Staff
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