Shares of the Wisconsin-based company soared in Monday pre-market trading and continued climbing more than 14% to US$2.50 following the opening bell.
Its lead candidate CLR 131 is a treatment for osteosarcoma, a rare pediatric cancer that begins in the cells that form bones.
The Rare Pediatric Disease Designation is granted for diseases that affect children from birth to 18 years old and affect fewer than 200,000 persons in the US.
“CLR 131 has demonstrated promise as an anticancer agent in preclinical and clinical settings, and we are working now to establish its impact on various rare and deadly pediatric cancers,” said John Friend, chief medical officer of Cellectar, in the company’s press release.
The designation has been granted to CLR 131 in four pediatric cancers, including neuroblastoma, rhabdomyosarcoma and Ewing’s Sarcoma.
An RPDD can lead to a priority review voucher, which cuts down the FDA’s review time in half to six months.