Cellectar Biosciences(US:CLRB) Globenewswireยท2025-09-09 12:05Core Insights - Cellectar Biosciences is making progress with the European Medicines Agency (EMA) regarding a potential Conditional Marketing Authorization (CMA) submission for Iopofosine I 131 to treat Waldenstrom Macroglobulinemia (WM), with a decision expected in late Q3 or early Q4 2025 [1][3] - The company intends to pursue an accelerated approval with the U.S. Food and Drug Administration (FDA) for Iopofosine I 131 as a treatment for WM, contingent on raising sufficient funding and the initiation of a confirmatory trial [2][3] - Cellectar is advancing its Auger-emitting radiopharmaceutical candidate, CLR 125, into a Phase 1b clinical trial for the treatment of triple-negative breast cancer (TNBC) planned for Q4 2025 [1][3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate (PDC) delivery platform [3][4] - The company's product pipeline includes Iopofosine I 131, CLR 121225 (an actinium-225 based program), and CLR 121125 (an iodine-125 Auger-emitting program) targeting various solid tumors [5] Clinical Trials and Regulatory Progress - Data from the Phase 2b CLOVER WaM clinical trial for Iopofosine I 131 showed a statistically significant major response rate and meaningful duration of response, supporting the CMA submission to the EMA [3][6] - The FDA has granted Iopofosine I 131 multiple designations, including six Orphan Drug and four Rare Pediatric Drug designations, indicating its potential in treating various cancer indications [6] Future Plans - The company plans to share new data from the Phase 2b trial at an upcoming medical or scientific conference, which includes 12-month follow-up results and subset analyses [3] - Cellectar is executing long-term supply agreements for iodine-125 and actinium-225 to support its clinical studies and future commercial needs [3]