Israeli business stage biopharmaceutical firm BioLineRx Ltd. (Nasdaq: BLRX; TASE: BLRX) right this moment introduced that the US Meals and Drug Administration (FDA) has authorized APHEXDA (motixafortide) together with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for assortment and subsequent autologous transplantation in sufferers with a number of myeloma. APHEXDA is run by injection, for subcutaneous use.
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BioLineRx’s share value is up 5.6% on Nasdaq at $2.20, giving a market cap of $135.4 million. The share value has risen 320% over the previous six months.
BioLineRx CEO Philip Serlin advised “Globes” that the product will likely be prepared for advertising and marketing in just a few weeks. It’s produced by subcontractors within the US and Europe, who’re already ready to supply it in business portions. The product is taken into account an orphan drug (that’s, it targets a comparatively small market), and up to now Serlin defined that comparatively few salespeople are wanted to cowl the majority of the market, about 80 hospitals within the US the place most transplants are carried out. The product itself is comparatively easy to fabricate and use as a subcutaneous injection. Along with the US market, the place it plans to function alone, BioLineRx has additionally signed an settlement to market the product within the Asian market.
A number of myeloma is the second most-common hematologic malignancy. Autologous stem cell transplantation (ASCT) is a part of the usual of care therapy paradigm for a number of myeloma and delivers extended survival for sufferers with this most cancers kind. The success of ASCT depends upon satisfactory mobilization of stem cells through the therapy course of.
As of the top of June 2023, BioLineRx had $32.8 million in money. The corporate estimated that the quantity could be sufficient to help its present actions, together with the advertising and marketing of the brand new product after approval, into the primary half of 2024. This calculation doesn’t consider $29.5 million, which ought to come from the settlement it has signed to market the product in Asia.
Printed by Globes, Israel enterprise information – en.globes.co.il – on September 11, 2023.
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