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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) reported its Q1 2022 financial results, highlighting significant progress on Motixafortide's New Drug Application (NDA) for stem cell mobilization, expected to be submitted to the FDA by mid-2022. The company ended Q1 with $50.6 million in cash, sufficient to fund operations into H1 2024. A market assessment estimates a $360 million opportunity in the U.S. for stem cell mobilization. Positive cost-effectiveness results were reported, showing savings of ~$30,000 versus other treatments. The net loss narrowed to $4.9 million from $10.2 million year-over-year.
BioLineRx Ltd. (NASDAQ: BLRX) will announce its unaudited financial results for Q1 2022 on May 11, 2022, before US markets open. A conference call hosted by CEO Philip Serlin is scheduled for the same day at 10:00 a.m. EDT. The call will be accessible via the Company's Investor Relations page. BioLineRx focuses on oncology, with key programs including Motixafortide for cancer therapy and AGI-134, aimed at treating solid tumors. A replay will be available post-call.
BioLineRx Ltd. (NASDAQ: BLRX) announced its 2021 financial results, reporting a net loss of $27.1 million, less than the $30 million loss in 2020. The company holds $57.1 million in cash and equivalents. A significant highlight was the positive outcome of a pharmacoeconomic study for Motixafortide, showing substantial cost savings compared to current treatments. BioLineRx plans to submit an NDA for Motixafortide in mid-2022, targeting a $360 million US market. The company aims for a potential FDA approval and US launch of Motixafortide in 2023.
BioLineRx Ltd. (NASDAQ: BLRX), a biopharmaceutical company focused on oncology, will release its audited financial results for the year ended December 31, 2021 on March 16, 2022, before market opening. A conference call featuring CEO Philip Serlin will occur on the same day at 10:00 a.m. EST. Investors can access a live webcast on the Investor Relations page. The company's lead drug, Motixafortide, is in advanced stages for various cancer treatments.
On March 3, 2022, BioLineRx Ltd. (NASDAQ: BLRX) announced positive findings from a pharmacoeconomic study evaluating the cost-effectiveness of Motixafortide combined with G-CSF compared to plerixafor plus G-CSF in multiple myeloma patients. The study showed approximately $30,000 in net cost savings and improved health resource utilization during autologous stem cell transplantation. CEO Philip Serlin emphasized that these results support Motixafortide as a potential new standard of care. The company plans to file an NDA in mid-2022, targeting a market estimated at over $360 million in the US.
BioLineRx Ltd. (NASDAQ: BLRX) has completed enrollment in the Phase 1/2a study of AGI-134, its innovative intratumoral cancer vaccine for unresectable metastatic solid tumors. The study, which enrolled 38 patients across the UK, Spain, and Israel, aims to assess AGI-134's safety and biological activity. Results are expected in H1 2022. AGI-134 demonstrated potential in preclinical trials, showing tumor regression and reduced metastases. BioLineRx continues to develop AGI-134 and has established an Immuno-Oncology Scientific Advisory Board to guide its research efforts.
BioLineRx Ltd. (NASDAQ-CM: BLRX) announced a successful pre-New Drug Application (NDA) meeting with the FDA regarding Motixafortide, intended for stem-cell mobilization in multiple myeloma patients. The FDA confirmed that the Phase 3 GENESIS study's data is adequate for NDA submission, expected in H1 2022. The GENESIS trial demonstrated statistically significant results, with approximately 90% of patients proceeding to transplantation after one dose of Motixafortide. If approved, Motixafortide may set a new standard in mobilization therapy for multiple myeloma.
BioLineRx Ltd. (NASDAQ: BLRX) updated investors on the successful results from the GENESIS Phase 3 trial of Motixafortide (BL-8040) presented at the 63rd ASH Annual Meeting. The trial showed that 92.5% of patients using Motixafortide plus G-CSF achieved the primary endpoint of mobilizing ≥6M CD34+ cells/kg, significantly outperforming the placebo group. The need for improved stem cell mobilization therapies is underscored due to challenges in modern multiple myeloma treatments. CEO Philip Serlin expressed enthusiasm for Motixafortide as a standard care component and announced plans for a pre-NDA FDA meeting.
BioLineRx Ltd. (NASDAQ: BLRX) announced the establishment of a Scientific Advisory Board (SAB) focused on immuno-oncology. The SAB includes renowned experts like Ronald Levy from Stanford University and Jon Wigginton, previously of Bristol-Myers Squibb. CEO Philip Serlin expressed optimism about leveraging the expertise of these leaders to enhance the company's clinical development efforts. BioLineRx's lead asset, Motixafortide, is approaching NDA submission for stem cell mobilization with an FDA meeting planned soon. The company also develops AGI-134, an immunotherapy currently in early trials.
BioLineRx reports strong progress in its clinical programs, especially for Motixafortide in stem cell mobilization, showing a net cost savings of $17,000 per patient versus G-CSF alone. A pre-NDA meeting with the FDA is planned for mid-December, with an NDA submission expected in H1 2022. As of September 30, 2021, the company holds $62.2 million in cash and equivalents, supporting ongoing development. Third-quarter net loss increased to $5.7 million from $4.6 million year-over-year, with rising R&D expenses. Upcoming milestones include completing recruitment for AGI-134 trials.
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