Cellectar Plans to Submit iopofosine I 131 for Conditional Approval in Europe by 3Q 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 09 2026
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Source: Newsfilter
- Regulatory Milestone: Cellectar plans to submit a Conditional Marketing Authorization application for iopofosine I 131 to the EMA in 3Q 2026, with potential approval in early 2027, which would allow the company to access approximately 30 countries, significantly expanding its market share in WM treatment.
- Clinical Progress: The company anticipates dosing the first patients in the Phase 1b study of CLR 125 for triple-negative breast cancer in 1Q 2026, with interim data expected in mid-2026, which will provide crucial support for the expansion of its product line in this high-demand area.
- Funding Support: Cellectar raised approximately $15.2 million through financings and warrant exercises to support pipeline development and regulatory milestones, ensuring adequate funding for future clinical trials and market launches.
- Strategic Showcase: Cellectar will highlight its strategic initiatives at the 2026 Biotech Showcase, with CEO James Caruso presenting a corporate update on January 14, 2025, showcasing the company's innovative advancements in WM and triple-negative breast cancer, further boosting investor confidence.
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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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Cellectar Plans to Submit iopofosine I 131 for European Approval in 3Q 2026
- Regulatory Milestone: Cellectar plans to submit a Conditional Marketing Authorization application for iopofosine I 131 to the EMA in 3Q 2026, with potential approval in early 2027, positioning the company to capture significant market share among WM patients in Europe.
- Clinical Advancement: The company anticipates dosing the first patients in a Phase 1b study of CLR 125 for triple-negative breast cancer in 1Q 2026, with interim data expected in mid-2026, further validating its therapeutic potential in a challenging market.
- Funding Support: Cellectar raised approximately $15.2 million through financings and warrant exercises to support pipeline development and regulatory milestones, ensuring its continued growth in the competitive biopharmaceutical landscape.
- Strategic Showcase: Cellectar will highlight its 2026 strategic initiatives at the upcoming Biotech Showcase, emphasizing its innovations in cancer treatment and market expansion potential, thereby boosting investor confidence.
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