Cellectar plans European approval submission for iopofosine I 131
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 04 2025
0mins
Should l Buy CLRB?
Cellectar Biosciences Inc's stock surged by 16.56% as it crossed above the 5-day SMA, reflecting positive investor sentiment.
The company announced plans to submit a Conditional Marketing Authorization application for iopofosine I 131 to the EMA in 3Q 2026, which could significantly expand its market share in WM treatment across approximately 30 countries. Additionally, Cellectar is preparing to initiate a Phase 1b study for CLR 125 in triple-negative breast cancer, with interim data expected in mid-2026, further enhancing its clinical pipeline. The company also raised $15.2 million to support these initiatives, boosting investor confidence.
This strategic move positions Cellectar favorably in the competitive biopharmaceutical landscape, potentially leading to increased market presence and investor interest as it showcases its advancements at the upcoming Biotech Showcase.
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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.
Bark Inc (BARK) Shares Surge 19.9% on Acquisition Proposal from Great Dane
- Acquisition Proposal: Great Dane's submission of a non-binding acquisition letter to Bark Inc has led to a 19.9% surge in Bark's pre-market share price to $0.74, indicating strong market enthusiasm for the potential acquisition.
- Market Reaction: The significant rise in Bark Inc's stock price reflects investor optimism regarding the company's future, which may also attract more investor attention and enhance market liquidity for the stock.
- Industry Dynamics: In pre-market trading, Signing Day Sports Inc saw a 43.7% increase, while Ping An Biomedical Co Ltd rose 34.3%, highlighting strong market interest in the biotech and sports sectors, which could influence Bark Inc's market positioning.
- Investor Confidence: The rebound in Bark Inc's stock price may bolster investor confidence in the company, especially after recent market volatility, as the acquisition proposal provides new momentum for future growth.
See More
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.
See More
Cellectar Plans to Submit iopofosine I 131 for Conditional Approval in Europe by 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, 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.
See More
Cellectar Biosciences Secures Multi-Year Supply Agreement with Ionetix for Key Radioisotopes
- Strategic Partnership: Cellectar Biosciences has signed a multi-year supply agreement with Ionetix to secure clinical and commercial-scale supplies of Ac-225 and At-211 radioisotopes, which is expected to accelerate the advancement of its targeted alpha therapy candidates in cancer treatment.
- Technological Edge: Cellectar's Phospholipid Drug Conjugate platform technology effectively delivers isotopes directly to tumor cells, with Ac-225 and At-211 providing an ideal high-energy radiation solution for treating challenging solid tumors like pancreatic cancer, enhancing therapeutic efficacy.
- Production Capacity Expansion: Ionetix is installing a second cyclotron at its Michigan facility dedicated to commercial-scale production of Ac-225 and At-211, ensuring it meets the growing market demand and supports Cellectar's next-generation targeted therapies.
- Market Outlook: This collaboration not only provides Cellectar with a reliable isotope supply but also drives innovation in cancer treatment, which is anticipated to significantly enhance the company's competitiveness and market share in the biopharmaceutical sector.
See More
Cellectar Biosciences Signs Multi-Year Supply Agreement with Ionetix for Key Radioisotopes
- Supply Agreement Signed: Cellectar Biosciences has entered into a multi-year supply agreement with Ionetix to secure clinical and commercial-scale supplies of Ac-225 and At-211 radioisotopes, which will support clinical trials and potential commercialization of targeted alpha therapy candidates.
- Platform Technology Advantage: Cellectar's Phospholipid Drug Conjugate platform technology effectively delivers isotopes directly to tumor cells, and the combination of Ac-225 and At-211 enhances its potential application in treating challenging solid tumors like pancreatic cancer.
- Production Capacity Expansion: Ionetix is installing a second cyclotron at its Michigan facility dedicated to commercial-scale production of Ac-225 and At-211, addressing the growing market demand and ensuring a steady supply for Cellectar's drug development pipeline.
- Strategic Implications: This collaboration not only provides Cellectar with a reliable supply of high-quality isotopes but also propels the expansion of its radiotherapeutic pipeline, further solidifying its market position in cancer treatment.
See More
Cellectar Indicates 2027 Worldwide Release for Iopofosine as Regulatory Progress Gains Speed
Management Progress: Cellectar Biosciences reported significant advancements in Q3 2025, including eligibility for conditional marketing approval in the EU for iopofosine, with plans for a potential global launch by 2027. The company is also advancing clinical programs for CLR 125 and CLR 225.
Financial Overview: The company ended the quarter with $12.6 million in cash, down from $23.3 million at the end of 2024, but raised $5.8 million through stock issuance. Research and development expenses decreased significantly, contributing to a net loss of $4.4 million for the quarter.
Regulatory and Strategic Outlook: Management is optimistic about regulatory progress and is in discussions with potential partners for iopofosine. They plan to submit the application for EU marketing approval in mid-2026, with U.S. approval potentially occurring sooner.
Risks and Challenges: Financing remains a critical challenge for advancing clinical trials, particularly for the Phase III study in the U.S. Additionally, pricing negotiations in Europe may impact revenue potential, highlighting the need for sufficient funding to support ongoing operations and regulatory filings.
See More
Bark Inc (BARK) Shares Surge 19.9% on Acquisition Proposal from Great Dane
- Acquisition Proposal: Great Dane's submission of a non-binding acquisition letter to Bark Inc has led to a 19.9% surge in Bark's pre-market share price to $0.74, indicating strong market enthusiasm for the potential acquisition.
- Market Reaction: The significant rise in Bark Inc's stock price reflects investor optimism regarding the company's future, which may also attract more investor attention and enhance market liquidity for the stock.
- Industry Dynamics: In pre-market trading, Signing Day Sports Inc saw a 43.7% increase, while Ping An Biomedical Co Ltd rose 34.3%, highlighting strong market interest in the biotech and sports sectors, which could influence Bark Inc's market positioning.
- Investor Confidence: The rebound in Bark Inc's stock price may bolster investor confidence in the company, especially after recent market volatility, as the acquisition proposal provides new momentum for future growth.
See More
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.
See More
Cellectar Plans to Submit iopofosine I 131 for Conditional Approval in Europe by 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, 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.
See More
Cellectar Biosciences Secures Multi-Year Supply Agreement with Ionetix for Key Radioisotopes
- Strategic Partnership: Cellectar Biosciences has signed a multi-year supply agreement with Ionetix to secure clinical and commercial-scale supplies of Ac-225 and At-211 radioisotopes, which is expected to accelerate the advancement of its targeted alpha therapy candidates in cancer treatment.
- Technological Edge: Cellectar's Phospholipid Drug Conjugate platform technology effectively delivers isotopes directly to tumor cells, with Ac-225 and At-211 providing an ideal high-energy radiation solution for treating challenging solid tumors like pancreatic cancer, enhancing therapeutic efficacy.
- Production Capacity Expansion: Ionetix is installing a second cyclotron at its Michigan facility dedicated to commercial-scale production of Ac-225 and At-211, ensuring it meets the growing market demand and supports Cellectar's next-generation targeted therapies.
- Market Outlook: This collaboration not only provides Cellectar with a reliable isotope supply but also drives innovation in cancer treatment, which is anticipated to significantly enhance the company's competitiveness and market share in the biopharmaceutical sector.
See More
Cellectar Biosciences Signs Multi-Year Supply Agreement with Ionetix for Key Radioisotopes
- Supply Agreement Signed: Cellectar Biosciences has entered into a multi-year supply agreement with Ionetix to secure clinical and commercial-scale supplies of Ac-225 and At-211 radioisotopes, which will support clinical trials and potential commercialization of targeted alpha therapy candidates.
- Platform Technology Advantage: Cellectar's Phospholipid Drug Conjugate platform technology effectively delivers isotopes directly to tumor cells, and the combination of Ac-225 and At-211 enhances its potential application in treating challenging solid tumors like pancreatic cancer.
- Production Capacity Expansion: Ionetix is installing a second cyclotron at its Michigan facility dedicated to commercial-scale production of Ac-225 and At-211, addressing the growing market demand and ensuring a steady supply for Cellectar's drug development pipeline.
- Strategic Implications: This collaboration not only provides Cellectar with a reliable supply of high-quality isotopes but also propels the expansion of its radiotherapeutic pipeline, further solidifying its market position in cancer treatment.
See More
Cellectar Indicates 2027 Worldwide Release for Iopofosine as Regulatory Progress Gains Speed
Management Progress: Cellectar Biosciences reported significant advancements in Q3 2025, including eligibility for conditional marketing approval in the EU for iopofosine, with plans for a potential global launch by 2027. The company is also advancing clinical programs for CLR 125 and CLR 225.
Financial Overview: The company ended the quarter with $12.6 million in cash, down from $23.3 million at the end of 2024, but raised $5.8 million through stock issuance. Research and development expenses decreased significantly, contributing to a net loss of $4.4 million for the quarter.
Regulatory and Strategic Outlook: Management is optimistic about regulatory progress and is in discussions with potential partners for iopofosine. They plan to submit the application for EU marketing approval in mid-2026, with U.S. approval potentially occurring sooner.
Risks and Challenges: Financing remains a critical challenge for advancing clinical trials, particularly for the Phase III study in the U.S. Additionally, pricing negotiations in Europe may impact revenue potential, highlighting the need for sufficient funding to support ongoing operations and regulatory filings.
See More
