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/TASE: BLRX), a biopharmaceutical company in oncology, has announced that it has regained compliance with the Nasdaq minimum bid price requirement. This follows a notification on November 2, 2022, when the company failed to maintain a minimum bid price of $1.00 for 30 consecutive business days. Nasdaq granted a 180-day period for compliance, which the company successfully achieved by maintaining a closing bid price above $1.00 from April 10 to April 21, 2023. As a result, BioLineRx's American Depository Shares will remain listed on Nasdaq. The company is also advancing its lead product, motixafortide, with a New Drug Application accepted by FDA and a PDUFA date set for September 9, 2023.
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 (p<0.0001) 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.
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