NDA Submission Plans: Cellectar Biosciences intends to submit a New Drug Application (NDA) to the U.S. FDA for accelerated approval of iopofosine I 131 as a treatment for Waldenstrom Macroglobulinemia, contingent on funding and the initiation of a confirmatory trial. They are also working towards a Conditional Market Authorization submission in the EU, with a decision expected by late 2025.
Financial Performance and Pipeline Progress: The company reported a net loss of $5.4 million for Q2 2025, down from $0.9 million in the same period last year, while advancing its pipeline, including plans to initiate a Phase 1 trial for CLR 125 targeting triple-negative breast cancer by late 2025.
CLRB
$3.18+Infinity%1D
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.
