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Tuesday, January 18, 2022 9:17:05 AM
Jan. 18, 2022 8:44 AM ETBioLineRx Ltd. (BLRX)
By: Dulan Lokuwithana, SA News
BioLineRX (NASDAQ:BLRX) ADRs have added ~6.5% in the pre-market after the company announced the successful conclusion of a pre-New Drug Application (NDA) meeting with the FDA for Motixafortide, its therapeutic candidate for multiple myeloma patients.
Motixafortide is undergoing late-stage studies as a stem-cell mobilization agent for autologous bone marrow transplantation in multiple myeloma patients.
At the meeting, the federal agency has confirmed that a proposed data package from a single Phase 3 pivotal study will be adequate for its NDA submission, which the company anticipates in H1 2022.
"We are highly encouraged by the collaborative pre-NDA meeting that we held with the FDA, and having confirmed alignment with the agency, our NDA submission remains on track for the first half of this year," CEO Philip Serlin noted.
In May 2021, BioLineRX (BLRX) disclosed topline data from its GENESIS Phase 3 trial for Motixafortide.
Recent BLRX News
- 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
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 02/28/2024 12:08:12 PM
- 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
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 12/29/2023 09:20:42 PM
- Form F-3 - Registration statement by foreign private issuers • Edgar (US Regulatory) • 12/29/2023 09:15:45 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/21/2023 12:05:53 PM
- 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
- Monday’s Wall Street Highlights: GM, Microsoft, Citigroup, Amazon, and more • IH Market News • 11/20/2023 11:25:08 AM
- 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
- New Collaboration Could Revolutionize Treatment of Chronic Spinal Cord Injuries • AllPennyStocks.com • 10/18/2023 09:07:00 PM
- 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
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 09/11/2023 11:07:26 AM
- BioLineRx Announces FDA Approval of APHEXDA™ (motixafortide) in Combination with Filgrastim (G-CSF) to Mobilize Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma • PR Newswire (US) • 09/11/2023 11:00:00 AM
- Wednesday’s Wall Street Highlights: Ambarella, Alphabet, Toyota, HP Inc, Vinfast, and more • IH Market News • 08/30/2023 11:16:41 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/30/2023 11:15:24 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/30/2023 10:45:19 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/08/2023 09:25:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 07/17/2023 11:10:43 AM
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