BioLineRX Ltd - BLRX STOCK NEWS

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.

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.