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BioLineRx Ltd. develops oncology and rare-disease therapies, with recurring updates centered on GLIX1, APHEXDA (motixafortide), and motixafortide development in solid tumors.
Company news covers GLIX1 clinical development for glioblastoma and other solid tumors under its Hemispherian collaboration, intellectual-property developments tied to GLIX1, financial results, and corporate updates. APHEXDA is approved in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma and is commercialized by partners, while BioLineRx has retained motixafortide rights for solid-tumor programs including metastatic pancreatic cancer.
BioLineRx announced significant findings from its GENESIS Phase 3 clinical trial, published in Nature Medicine. The trial demonstrated that motixafortide coupled with granulocyte colony-stimulating factor (G-CSF) significantly mobilized hematopoietic stem cells compared to a placebo, achieving statistical significance (p0.0001) across all endpoints. The study included diverse patients, reflecting the current multiple myeloma population. Remarkably, motixafortide led to a 10.5-fold increase in primitive stem cell collections. This is pivotal as stem cell mobilization remains a critical challenge in treating multiple myeloma patients undergoing autologous stem cell transplantation (ASCT). BioLineRx's New Drug Application (NDA) for motixafortide is under FDA review, with a target decision date of September 9, 2023.
BioLineRx Ltd. (NASDAQ: BLRX) announced significant advancements, including the FDA's acceptance of the new drug application for APHEXDA® (motixafortide) in stem cell mobilization, with a PDUFA target action date set for September 9, 2023. The company appointed Tami Rachmilewitz, M.D. as Chief Medical Officer and completed its U.S. commercial leadership team focused on drug launch and sales. Additionally, BioLineRx entered a clinical trial collaboration with Washington University to evaluate motixafortide's use in gene therapies for sickle cell disease. Financially, the company reported a net loss of $25 million for 2022, with sufficient cash reserves of $51.1 million to fund operations into the first half of 2024.
BioLineRx Ltd. (NASDAQ: BLRX) will announce its audited financial results for the fiscal year ending December 31, 2022, on March 22, 2023, before the U.S. markets open. A conference call featuring CEO Philip Serlin will occur on the same day at 10:00 a.m. EDT. The company focuses on oncology, with its lead drug, motixafortide, showing promise in treating various cancers, including positive results in multiple clinical trials. The FDA has accepted its NDA submission for motixafortide with a PDUFA date set for September 9, 2023. Further studies for motixafortide and a new oncology program, AGI-134, are planned for 2023.
BioLineRx Ltd. (NASDAQ: BLRX) has announced a collaboration with Washington University to conduct a Phase 1 clinical trial for motixafortide, aimed at mobilizing CD34+ hematopoietic stem cells for gene therapies in sickle cell disease (SCD). This trial, part of a broader strategy for motixafortide's application across various therapeutic areas, addresses the significant mobilization challenges faced by SCD patients. The trial will assess the safety and feasibility of motixafortide alone and in combination with natalizumab. Enrollment is expected to start in the second half of 2023, highlighting the potential to offer significant advancements in gene therapy options for SCD.
BioLineRx Ltd. (NASDAQ:BLRX) has appointed Dr. Tami Rachmilewitz as Chief Medical Officer, effective January 4, 2023. Dr. Rachmilewitz brings over 15 years of clinical development experience, previously holding leadership roles at VBL Therapeutics and other notable companies. Her expertise will support BioLineRx's upcoming initiatives, including the launch of APHEXDA® and the further development of the drug motixafortide across various therapeutic areas. This appointment aims to enhance the company's capabilities in bringing innovative treatments to cancer patients.
BioLineRx Ltd. (NASDAQ: BLRX) announced positive results from its Phase 1/2a study of AGI-134, an investigational cancer vaccine for unresectable metastatic solid tumors. The study met its primary endpoint of safety and tolerability, with no dose-limiting toxicities and a recommended dose of 200mg for further trials. Immune activity was also observed, with 29% of patients achieving stable disease. The company plans to publish full data analysis in 2023 and will consult its advisory board for next steps.
BioLineRx Ltd. (NASDAQ: BLRX) announced its participation in the 12th Annual LifeSci Partners Corporate Access Event occurring from January 9-11, 2023, in San Francisco, CA. Management will be available for one-on-one meetings on January 11, 2023. BioLineRx focuses on oncology, with its lead drug, motixafortide, showing promise in multiple studies, including a Phase 3 trial for multiple myeloma and a Phase 2a trial for pancreatic cancer. The FDA has accepted its NDA submission with a PDUFA date of September 9, 2023.
BioLineRx Ltd. announced the FDA's acceptance of its New Drug Application for APHEXDA® (motixafortide), aimed at mobilizing stem cells for multiple myeloma treatment, with a PDUFA target date of September 9, 2023. The company plans to independently commercialize APHEXDA® in the U.S., naming Holly May as President of BioLineRx USA. BioLineRx completed a $40 million debt financing and a $15 million equity offering to support the product launch. The company reported a net loss of $6.8 million for Q3 2022 and had $57.3 million in cash as of September 30, 2022.
BioLineRx Ltd. (NASDAQ/TASE: BLRX), a biopharmaceutical company focused on oncology, will release its unaudited financial results for Q3 2022 on November 15, 2022, before U.S. markets open. The conference call, featuring CEO Philip Serlin, is scheduled for 10:00 a.m. EST on the same day. Interested parties can join by dialing +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally, or via webcast. A replay will be available two hours post-call. BioLineRx's lead program, motixafortide, has a PDUFA date of September 9, 2023.
BioLineRx Ltd. (NASDAQ: BLRX) announced that the FDA has accepted its New Drug Application (NDA) for APHEXDA® (motixafortide), targeting improved stem cell mobilization in multiple myeloma patients. The NDA is based on the GENESIS Phase 3 trial, which met all endpoints with high statistical significance. A PDUFA action date is set for September 9, 2023. The company is preparing for a robust commercial launch, highlighting a potential to enhance patient outcomes and reduce healthcare resource usage.