Cellectar Biosciences targets late 2026 for Phase III trial initiation and potential Waldenström macroglobulinemia approval in H2 2027.
Cellectar Biosciences outlined plans to begin its Phase III trial in late Q4 2026, aiming for Waldenström macroglobulinemia (WM) approval in the second half of 2027. The timeline follows positive 12-month data from the Phase IIb CLOVER WaM study, which demonstrated durable responses for iopofosine.
In Q1 2026, management called the period transformational, citing consistent clinical outcomes. The Phase IIb results met key efficacy benchmarks, supporting the accelerated development pathway. No prior Phase III data for WM exists for comparison.
Shares of CLRB showed no immediate reaction to the announcement during the earnings call.