BioLine RX Ltd
NASDAQ:BLRX
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BioLine RX Ltd
BioLineRx Ltd. is a clinical stage biopharmaceutical company, which focuses on oncology. The firm is commited into in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development andcommercialization. The firm is commited into two projects: Motixafortide (BL-8040), which is a cancer therapy platform , and AGI-134, an immunotherapy treatment.
BioLineRx Ltd. is a clinical stage biopharmaceutical company, which focuses on oncology. The firm is commited into in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development andcommercialization. The firm is commited into two projects: Motixafortide (BL-8040), which is a cancer therapy platform , and AGI-134, an immunotherapy treatment.
Motixafortide NDA Progress: The FDA assigned a PDUFA target action date of September 9, 2023, for Motixafortide in stem cell mobilization, and BioLineRx remains on track for potential approval and launch.
Commercial Readiness: BioLineRx completed hiring an experienced U.S. sales force and advanced supply chain and market access activities to prepare for a potential launch.
Key Clinical Milestone: Positive Phase III results for Motixafortide were published in Nature Medicine, showing statistically significant outcomes for stem cell mobilization.
Financial Position: BioLineRx ended Q1 2023 with $43.3 million in cash, not including an additional $30 million available via a debt agreement, and expects its current funds to last into the first half of 2024.
Pipeline Developments: New clinical collaborations are underway in sickle cell gene therapy and metastatic pancreatic cancer, with multiple trials expected to initiate or report data in the second half of 2023.
R&D Spending: Research and development expenses declined by nearly 17% year-over-year, mainly due to lower spending on Motixafortide NDA-support and AGI-134 trials.