Cellectar Biosciences Stock Rises Over EMA's Advise On CMA Filing For Iopofosine I 131

(RTTNews) - Cellectar Biosciences, Inc. (CLRB), Monday announced that the Scientific Advice Working Party or SAWP of the European Medicines Agency has advised filing for a Conditional Marketing Authorization or CMA for iopofosine I 131 as a treatment in patients with Waldenstrom macroglobulinemia.

The decision follows SAWP's advice that iopofosine I 131 met the eligibility requirements for a CMA submission for the proposed patient population.

If approved, iopofosine I 131 could be commercially available in the 30 countries represented by the agency in 2027.

Also, Iopofosine I 131 has been granted PRIority MEdicines or PRIME designation from the EMA for the treatment of patients with WM who received at least two prior lines of therapy.

Backed by PRIME designation and SAWP feedback, the company is advancing toward a potential European approval and commercial availability in 2027.

Moreover, the US NDA will be submitted once the confirmatory trial is underway and will be supported by data from the Phase 2b CLOVER WaM clinical trial, which showed a statistically significant major response rate compared to a null hypothesis of 20 percent and meaningful duration of response.

In the pre-market hours, CLRB is climbing 11.94 percent, to $6.47 on the Nasdaq.