CLR 125

Jan. 9, 2026: Cellectar Biosciences, Inc. (NASDAQ: CLRB) outlined 2026 catalyst plans. For iopofosine I 131 in Waldenström’s macroglobulinemia (WM), the company said EMA SAWP feedback supports a Conditional Marketing Authorization (CMA) filing based on the Phase 2 CLOVER WaM study; it expects to submit the CMA application in 3Q 2026 with potential European approval in early 2027, and is also advancing NDA preparations for a U.S. accelerated approval pathway. The company plans to present final results and a subset analysis from the CLOVER WaM Phase 2 study.

Pipeline/other programs: Cellectar anticipates dosing the first patients in a Phase 1b CLR 125 (iodine-125 Auger-emitting) study in triple-negative breast cancer (TNBC) in 1Q 2026 and expects interim data in mid-2026. It also plans to prepare actinium-based CLR 225 for first-in-human trials in pancreatic cancer and to progress additional PDC-based candidates into preclinical/IND-enabling studies. The company will evaluate commercialization partnerships for iopofosine I 131.