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BioLineRx (BLRX) FDA Events

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FDA Events for BioLineRx (BLRX)

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

BioLineRx's Drugs in FDA Review

motixafortide - FDA Regulatory Timeline and Events

motixafortide is a drug developed by BioLineRx for the following indication: For Collection and Subsequent Autologous Transplantation in Patients with 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.

Soquelitinib - FDA Regulatory Timeline and Events

Soquelitinib is a drug developed by BioLineRx for the following indication: For Collection and Subsequent Autologous Transplantation in Patients with 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.

BioLineRx FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, BioLineRx (BLRX) has reported FDA regulatory activity for the following drugs: Soquelitinib and motixafortide.

The most recent FDA-related event for BioLineRx occurred on June 25, 2025, involving Soquelitinib. The update was categorized as "Approved," with the company reporting: "Corvus Pharmaceuticals, Inc announced that the IND application submitted by its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), has been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to initiate a Phase 1b/2 clinical trial of soquelitinib for the treatment of patients with moderate-to-severe atopic dermatitis in China."

Current therapies from BioLineRx in review with the FDA target conditions such as:

  • For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma - Soquelitinib
  • For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma - motixafortide

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:BLRX) was last updated on 7/10/2025 by MarketBeat.com Staff
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