Welcome to our dedicated page for BioLineRX news (Ticker: BLRX), a resource for investors and traders seeking the latest updates and insights on BioLineRX stock.
BioLineRx Ltd. (NASDAQ: BLRX) is a commercial-stage biopharmaceutical company based in Modi'in, Israel, with operations extending to the United States. The company specializes in developing life-changing therapies for oncology and rare diseases. BioLineRx's flagship product, APHEXDA® (motixafortide), has gained approval in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma patients.
Currently, the company is advancing a robust pipeline of investigational medicines targeting sickle cell disease, pancreatic cancer, and other solid tumors. One of their notable clinical-stage therapeutic candidates is motixafortide (BL-8040), a novel peptide showing promise in stem-cell mobilization and solid tumors. Another key candidate is AGI-134, an immuno-oncology agent dedicated to treating solid tumors.
BioLineRx recently announced definitive agreements with institutional investors for the issuance and sale of its American Depositary Shares (ADSs) and warrants. This equity transaction, combined with financial resources from an existing debt facility, positions the company well for the commercialization of APHEXDA and the advancement of its other pipeline programs. Additionally, the company is exploring motixafortide's potential in supporting gene therapy for sickle cell disease, collaborating with leaders in the gene therapy field such as St. Jude Children's Research Hospital and Washington University School of Medicine.
BioLineRx has also received recent notifications and presented new data at various esteemed conferences such as the American Society of Clinical Oncology (ASCO) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). These efforts underscore the company's commitment to bringing innovative therapies from the bench to the bedside.
To access more information about BioLineRx, visit their official website or follow them on Twitter and LinkedIn.
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.
BioLineRx Ltd. (NASDAQ/TASE: BLRX) received a notification letter from Nasdaq indicating non-compliance with the minimum bid price requirement, as the closing bid price for its ADSs was below USD $1.00 for 30 consecutive trading days. The company has until May 1, 2023, to regain compliance, with the possibility of an extension if necessary. This notice does not immediately affect the company's listing, and they will continue operations, focusing on the potential launch of APHEXA® for treating multiple myeloma patients.
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