Cellectar Biosciences Granted RPDD by U.S. FDA for Iopofosine I 131
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Oct 27 2025
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FDA Designation: Cellectar Biosciences received Rare Pediatric Drug Designation for iopofosine I 131, a novel cancer targeting agent for treating inoperable relapsed or refractory pediatric high-grade glioma.
Previous Designation: The FDA had previously granted Orphan Drug Designation for iopofosine I 131, highlighting its potential in addressing severe pediatric cancers.
Clinical Study Results: Interim results from the CLOVER-2 pHGG study indicated meaningful improvements in progression-free and overall survival for patients treated with iopofosine I 131.
Strategic Collaboration Opportunity: Cellectar's CEO emphasized the potential for strategic collaboration to expedite the development of this promising therapy for patients in need of new treatment options.
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Analyst Views on CLRB
About CLRB
Cellectar Biosciences, Inc. is a late-stage clinical biopharmaceutical company. The Company is focused on the discovery, development, and commercialization of drugs for treatment of cancer. The Company, through its phospholipid ether drug conjugate (PDC) delivery platform, is focused on developing PDCs that are designed to specifically target cancer cells. Its PDC platform possesses the potential for the discovery and development of cancer-targeting treatments, and it plans to develop PDCs both independently and through research and development collaborations. Its lead programs are: Iopofosine I 131 (iopofosine), a beta-emitting iodine-131-based program which has been studied extensively; CLR 121225, an actinium-225-based program; and CLR 121125, an iodine-125 Auger-emitting program. Iopofosine evaluation is ongoing in a Phase IIb study in r/r multiple myeloma and central nervous system lymphoma patients and the CLOVER-2 Phase Ib study for pediatric patients with high grade gliomas.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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