Cellectar Biosciences, Inc. (CLRB) on Tuesday announced positive 12-month follow-up data from its Phase 2b CLOVER WaM study evaluating iopofosine I 131 in patients with Waldenström acroglobulinemia, a rare, slow-growing blood cancer.
The updated dataset, which includes at least 12 months of follow-up for all enrolled patients as requested by the U.S. Food and Drug Administration, showed an overall response rate of 83.6%, while the major response rate reached 61.8%, meeting the study's primary endpoint.
Separately, the company said it has entered into securities purchase agreements with certain institutional investors and members of management to issue and sell up to $140 million in shares.
The financing is expected to support a confirmatory study and the filing of a New Drug Application seeking accelerated approval of iopofosine I 131 for the treatment of Waldenström macroglobulinemia with the FDA.
The company's shares were more than 80% up in pre-market trading after closing at $2.83 on Monday.
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