Cellectar Biosciences downgraded to Perform from Outperform at Oppenheimer

Oppenheimer downgraded Cellectar Biosciences (CLRB) to Perform from Outperform without a price target after the company announced the FDA will require that a pivotal study versus an active comparator be fully enrolled prior to accepting a new drug application for iopofosine-I131, which is seeking accelerated approval in Waldenstrom’s macroglobulinemia. The firm says regulatory clarity moves approval out of Cellectar’s hands, with the costs to reach approval estimated at an additional $40M. It believes the opportunity for approval of iopofosine-I131 has grown more distant.