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Cellectar Biosciences (CLRB) FDA Events

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FDA Events for Cellectar Biosciences (CLRB)

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

Cellectar Biosciences' Drugs in FDA Review

CLR 125 - FDA Regulatory Timeline and Events

CLR 125 is a drug developed by Cellectar Biosciences for the following indication: For the treatment of relapsed TNBC. 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.

Iopofosine I-131 - FDA Regulatory Timeline and Events

Iopofosine I-131 is a drug developed by Cellectar Biosciences for the following indication: Pediatric Brain and Solid Tumors. 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.

Cellectar Biosciences FDA Events - Frequently Asked Questions

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

In the past two years, Cellectar Biosciences (CLRB) has reported FDA regulatory activity for the following drugs: Iopofosine I-131 and CLR 125.

The most recent FDA-related event for Cellectar Biosciences occurred on June 24, 2025, involving CLR 125. The update was categorized as "Provided Update," with the company reporting: "Cellectar Biosciences, announced that the company has submitted a protocol with the U.S. Food and Drug Administration (FDA) for a Phase 1b Dose Finding study of its Auger emitting radiopharmaceutical, CLR 125, for the treatment of relapsed TNBC. CLR 125 is an iodine-125 Auger-emitting drug candidate targeting solid tumors, such as triple negative breast, lung and colorectal cancers."

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

  • Pediatric Brain and Solid Tumors - Iopofosine I-131
  • For the treatment of relapsed TNBC. - CLR 125

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