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Exicure (XCUR) FDA Approvals

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Exicure's Drug in the FDA Approval Process

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

Burixafor FDA Regulatory Timeline and Events

Burixafor is a drug developed by Exicure for the following indication: In Multiple Myeloma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Exicure FDA Events - Frequently Asked Questions

As of now, Exicure (XCUR) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Exicure (XCUR) has reported FDA regulatory activity for burixafor.

The most recent FDA-related event for Exicure occurred on February 5, 2026, involving burixafor. The update was categorized as "Publication," with the company reporting: "Exicure, Inc. announced the publication of results from a prior Phase 2 clinical study evaluating burixafor (GPC-100/TG-0054), a highly selective CXCR4 inhibitor, in the journal Annals of Hematology."

Currently, Exicure has one therapy (burixafor) targeting the following condition: In Multiple Myeloma.

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

FDA progress for NASDAQ:XCUR last updated on 2/5/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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