Core Insights - Cellectar Biosciences plans to submit for conditional marketing approval for iopofosine I 131 in Europe by Q3 2026, following guidance from the EMA [1][5] - The company aims to present final results from the Phase 2 CLOVER WaM clinical study of iopofosine I 131 and initiate a Phase 1b study for CLR 125 targeting triple-negative breast cancer in early 2026 [1][6] Clinical Development - Cellectar received positive feedback from the EMA's SAWP supporting a Conditional Marketing Authorization filing for iopofosine I 131 based on the CLOVER WaM study [5] - The FDA granted Breakthrough Designation for iopofosine I 131 in relapsed/refractory Waldenstrom's Macroglobulinemia [5] - A Phase 1b clinical study for CLR 125 has been initiated, targeting triple-negative breast cancer [5] Regulatory Milestones - The company plans to submit a CMA application to the EMA for iopofosine I 131 in WM in Q3 2026, with potential approval in early 2027 [6] - Preparations for a New Drug Application (NDA) for U.S. accelerated approval of iopofosine I 131 are underway [6] - The company is actively enrolling patients for the Phase 1b study of CLR 125, with interim data expected in mid-2026 [6] Financial Strategy - Cellectar raised approximately $15.2 million through financings and warrant exercises to support pipeline development and regulatory milestones [5] - The company is focused on disciplined capital management and exploring non-dilutive funding opportunities [7] - The anticipated conditional marketing approval in 2027 from the EMA could impact around thirty countries, potentially expanding the patient population significantly compared to the U.S. [7]