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BioLineRx's Pancreatic Cancer Drug Gets Orphan Drug Tag in EU

Zacks Equity Research

BioLineRx Ltd. 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 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 industry’s rise of 1.4%.

Last month, BioLineRx reported encouraging initial data from the triple combination arm of the ongoing phase IIa COMBAT/KEYNOTE-202 study on Motixafortide for treating second-line metastatic pancreatic cancer. This served as the basis for the orphan drug tag.

Moreover, BioLineRx has a collaboration agreement with Genentech, a unit of Roche RHHBY for evaluating Motixafortide in combination with Tecentriq (atezolizumab) in two phase Ib/II studies for solid tumor.

Meanwhile, Motixafortide is being investigated in a phase IIb study in consolidation acute myeloid leukemia (AML) and in a phase III study on stem cell mobilization for autologous bone-marrow transplantation.

Zacks Rank & Key Pick

BioLineRx currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Karyopharm Therapeutics Inc. KPTI, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Karyopharm’s loss per share estimates have narrowed 0.5% for 2020 over the past 60 days. The stock has soared 81.7% in the past year.

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