Biolinerx - BLRX STOCK NEWS

BioLineRx Ltd. (NASDAQ: BLRX) has appointed Holly W. May as its Chief Commercial Officer, a newly established role, effective June 16, 2022. Ms. May brings extensive experience in commercial strategy, having led 13 product launches, and will focus on the U.S. market for Motixafortide, pending FDA approval. The U.S. market for Motixafortide in stem cell mobilization is projected to be worth $360 million annually. BioLineRx aims to submit a New Drug Application to the FDA in mid-2022, continuing preparations for Motixafortide's launch.

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.