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Thursday, September 14, 2023 11:45:58 AM
BioLineRx reported its second piece of material good news in as many weeks with FDA approval of Aphexda for stem cell mobilization in multiple myeloma patients. The approval of the drug delivers additional credibility to BioLineRx’ other motixafortide programs and provides a tailwind to commercialization efforts in Asia. We expect to see IIA approval for the Asia deal in the next few months and could see first ex-US revenues shortly after. Other highlights for the company include the start of the Columbia University-sponsored Phase II PDAC trial, Washington University’s work on sickle cell disease and efforts advancing AGI-134 in solid tumors. The US commercialization team has been hard at work preparing for Aphexda’s approval and could have first sales in the next few weeks. Based on the approval of Aphexda, we increase our valuation to $7.00 per share reflecting an increase in the probability of regulatory success to 100%.
Recent BLRX News
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 06/18/2024 08:05:49 PM
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- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 05/28/2024 11:11:36 AM
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- BioLineRx Announces Poster Presentation on Apheresis Center Efficiency and CXCR4 Antagonists including APHEXDA® (motixafortide) in Patients with Multiple Myeloma at the ASFA 2024 Annual Meeting • PR Newswire (US) • 04/17/2024 11:00:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 03/04/2024 12:47:21 PM
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- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 02/16/2024 12:07:06 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 01/08/2024 05:15:22 AM
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- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/12/2023 12:07:30 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 11/20/2023 12:03:18 PM
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- BioLineRx a conclu un accord de licence exclusive pour le motixafortide en Asie, sous les conseils de MSQ Ventures • PR Newswire (Canada) • 11/01/2023 11:43:00 AM
- BioLineRx entered Exclusive License Agreement to Motixafortide in Asia, advisored by M.S.Q. Ventures • PR Newswire (Canada) • 10/31/2023 01:00:00 PM
- BioLineRx entered Exclusive License Agreement to Motixafortide in Asia, advisored by M.S.Q. Ventures • PR Newswire (US) • 10/31/2023 01:00:00 PM
- Form SC 13D - General statement of acquisition of beneficial ownership • Edgar (US Regulatory) • 10/26/2023 06:18:00 PM
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- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 10/12/2023 11:14:17 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 09/28/2023 11:11:10 AM
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