BioLineRx stem mobile drug for myeloma sufferers wins FDA nod


Israeli business degree biopharmaceutical corporate BioLineRx Ltd. (Nasdaq: BLRX; TASE: BLRX) nowadays introduced that america Meals and Drug Management (FDA) has authorized APHEXDA (motixafortide) together with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for assortment and next autologous transplantation in sufferers with more than one myeloma. APHEXDA is run via injection, for subcutaneous use.

BioLineRx’s percentage worth is up 5.6% on Nasdaq at $2.20, giving a marketplace cap of $135.4 million. The proportion worth has risen 320% over the last six months.

BioLineRx CEO Philip Serlin advised “Globes” that the product might be able for advertising and marketing in a couple of weeks. It’s produced via subcontractors in america and Europe, who’re already ready to provide it in business amounts. The product is regarded as an orphan drug (this is, it goals a rather small marketplace), and up to now Serlin defined that rather few salespeople are had to duvet the majority of the marketplace, about 80 hospitals in america the place maximum transplants are carried out. The product itself is rather easy to fabricate and use as a subcutaneous injection. Along with america marketplace, the place it plans to perform by myself, BioLineRx has additionally signed an settlement to marketplace the product within the Asian marketplace.

A couple of myeloma is the second one most-common hematologic malignancy. Autologous stem mobile transplantation (ASCT) is a part of the usual of care remedy paradigm for more than one myeloma and delivers extended survival for sufferers with this most cancers sort. The luck of ASCT will depend on ok mobilization of stem cells right through the remedy procedure.

As of the tip of June 2023, BioLineRx had $32.8 million in money. The corporate estimated that the volume could be sufficient to reinforce its present actions, together with the selling of the brand new product after approval, into the primary part of 2024. This calculation does no longer take note $29.5 million, which will have to come from the settlement it has signed to marketplace the product in Asia.

Revealed via Globes, Israel trade information – – on Sep 11, 2023.

© Copyright of Globes Writer Itonut (1983) Ltd., 2023.



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