India, June 4 -- Shares of Cellectar Biosciences, Inc. (CLRB) were gaining around 71 percent in the pre-market activity on the Nasdaq after the company announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for iopofosine I 131 for the treatment of relapsed/refractory Waldenstrom macroglobulinemia or r/r WM.
The designation has been supported by CLOVER WaM Phase 2 Study data, which reported an 83.6% overall response rate.
Separately, the company announced that it has provided the European Medicines Agency or EMA with a data package that includes extensive supportive preclinical, regulatory and manufacturing data, as well as safety and efficacy data from the CLOVER WaM Phase 2b clinical trial.
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