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FLORHAM PARK, N.J. - Cellectar Biosciences, Inc. (NASDAQ:CLRB), a clinical-stage biotech with a market capitalization of $18.5 million and strong liquidity position according to InvestingPro data, announced Monday that its cancer treatment iopofosine I 131 could be eligible for Conditional Marketing Authorization (CMA) in Europe for patients with Waldenstrom macroglobulinemia (WM) who have failed Bruton Tyrosine Kinase inhibitor (BTKi) therapy.
The Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA) advised that filing for CMA could be acceptable for the post-BTKi refractory patient population. If approved, the drug could become commercially available across 30 European countries by 2027. The company’s stock has shown strong momentum recently, with a positive return over the past three months, though it remains significantly below its 52-week high of $67.50.
Iopofosine I 131 has already received PRIME designation from the EMA for WM patients who received at least two prior lines of therapy. The company plans to submit its CMA application in early 2026.
WM is an incurable B-cell malignancy affecting an estimated 35,000 to 45,000 patients in Europe. The condition is characterized by bone marrow infiltration with clonal lymphoplasmacytic cells that produce monoclonal immunoglobulin M.
According to data from the CLOVER WaM Phase 2 study presented at the American Society of Hematology Conference in December 2024, iopofosine I 131 demonstrated an overall response rate of 83.6% and a major response rate of 58.2%. InvestingPro analysis suggests the stock is currently undervalued, with analysts setting price targets ranging from $18 to $76 per share.
"We are thrilled to take this important step toward bringing iopofosine I 131 to patients in Europe living with WM," said James Caruso, president and CEO of Cellectar.
The company is also pursuing U.S. approval through the FDA’s accelerated approval pathway, where the drug has received Breakthrough Therapy, Fast Track and Orphan Drug Designations for treating relapsed/refractory WM.
Cellectar noted that U.S. submission is contingent upon securing additional funding to support a confirmatory study, while European approval could occur prior to initiating this study.
This information is based on a company press release statement.
In other recent news, SelectR Biosciences reported its earnings for the second quarter of 2025, disclosing a net loss of $5.4 million, or $3.39 per share. This result significantly missed the earnings per share forecast of -$0.13, with a surprise percentage of 2507.69%. Despite the earnings miss, the company’s stock showed resilience in premarket trading. These developments are crucial for investors as they assess the company’s financial health and future prospects. The earnings report highlights the challenges SelectR Biosciences faces in meeting analyst expectations. Analysts and investors will likely keep a close watch on the company’s next moves.
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