Biolinerx Stock Price, News & Analysis

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.

BioLineRx Ltd. (NASDAQ: BLRX) plans to release its unaudited financial results for Q3 2021 on November 18, 2021, before U.S. markets open. A conference call will follow at 10:00 a.m. EST, featuring CEO Philip Serlin. Investors can access the call via the Investor Relations page. The lead oncology program, Motixafortide (BL-8040), is preparing for NDA submission after positive trial results. A second program, AGI-134, is in Phase 1/2a studies.

BioLineRx Ltd. (NASDAQ: BLRX) has announced an oral presentation and three poster presentations at the 63rd ASH Annual Meeting from December 11-14, 2021. The highlight is the GENESIS Phase 3 trial, which shows that Motixafortide with G-CSF significantly increases stem cell mobilization in multiple myeloma patients, achieving 92.5% mobilization of ≥6x10⁶ CD34+ cells/kg. Additionally, Motixafortide demonstrates potential as an immunomodulator. The company aims to submit an NDA in the first half of 2022, bolstering its position in the oncology market.