BioLineRx's Pancreatic Cancer Drug Gets Orphan Drug Tag In EU
Zacks Investment Research | Jan 14, 2020 09:56PM ET
BioLineRx Ltd. (NASDAQ:BLRX) announced that the European Commission (EC) has granted an orphan drug designation to its lead oncology program Motixafortide (BL-8040) for the treatment of pancreatic cancer. The candidate, a CXCR4 inhibitor, is currently being evaluated in a phase IIa study in combination with Merck’s (NYSE:MRK) PD-L1 inhibitor Keytruda (pembrolizumab) and chemotherapy for addressing the given indication.
The prestigious tag for Motixafortide was based on a positive opinion from the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP). The candidate already received the same status in the United States from the FDA for treating pancreatic cancer.
The EMA usually grants orphan medicinal product status to drugs that target serious or life-threatening conditions which are being developed to treat, prevent or diagnose diseases or conditions affecting not more than five in 10,000 people in the region. In addition to providing BioLineRx with certain benefits and incentives, this status will allow Motixafortide to enjoy a period of market exclusivity in the EU, if approved.
Shares of BioLineRx were up 3.4% following this news on Tuesday. However, the stock has plunged 73.1% in the past year against the Zacks Investment Research
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