Biolinerx - BLRX STOCK NEWS

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.

BioLineRx Ltd. (NASDAQ: BLRX) announced promising outcomes from a pharmacoeconomic study of Motixafortide as a primary stem cell mobilization (SCM) agent for multiple myeloma patients. Conducted by IQVIA, the study indicates that adding Motixafortide to granulocyte colony stimulating factor (G-CSF) results in a significant decrease in health resource utilization and potential savings of approximately $17,000 per patient. These findings suggest that Motixafortide could become the new standard of care for autologous stem cell transplantation, pending FDA approval in 2022.

BioLineRx Ltd. (NASDAQ: BLRX) reported its financial results for Q2 2021, announcing the successful GENESIS Phase 3 trial of Motixafortide in stem-cell mobilization, meeting all endpoints with p<0.0001. The company plans an NDA submission for Motixafortide in H1 2022, supported by ongoing pharmacoeconomic studies. Financially, BioLineRx ended Q2 with $66 million in cash. R&D expenses increased to $5.1 million, while Q2 net loss was $6.8 million, unchanged from 2020. The company aims for key milestones, including pre-NDA meetings and clinical trial results for its other asset, AGI-134.

BioLineRx Ltd. (NASDAQ: BLRX) will announce its unaudited financial results for Q2 2021 on August 18, 2021, before US markets open. A conference call, featuring CEO Philip Serlin, is scheduled for 10:00 a.m. EDT on the same day. Stakeholders can access the call via the Investor Relations page. BioLineRx focuses on oncology, with its lead program Motixafortide (BL-8040) evaluated in multiple studies, including for pancreatic cancer in collaboration with MSD. The company is also developing AGI-134 for solid tumors.

BioLineRx Ltd. (NASDAQ: BLRX) announces positive Q1 2021 results, emphasizing significant advancements in its Motixafortide therapy for stem-cell mobilization. Topline data from the GENESIS Phase 3 trial showed 88.3% success in patient transplants after one treatment, compared to 10.8% with standard care. The company aims to file an NDA with the FDA in H1 2022. Financially, a $34.5 million public offering strengthened its balance sheet, although the net loss rose to $10.2 million. Cash reserves totaled $58.1 million, supporting future developments.

BioLineRx Ltd. (NASDAQ: BLRX) will announce its unaudited financial results for Q1 2021 on May 26, 2021, before US market opening. A conference call featuring CEO Philip Serlin will take place at 10:00 a.m. EDT on the same day, accessible via the company’s Investor Relations page. The call can be dialed in through +1-866-744-5399 (US) or +972-3-918-0610 (internationally). A replay will be available for two hours post-call and until May 28 at +1-888-295-2634 (US) and +972-3-925-5904 (internationally).

BioLineRx Ltd. (NASDAQ: BLRX) reported favorable top-line results from its GENESIS Phase 3 trial of Motixafortide for bone marrow transplantation in multiple myeloma patients. The trial showed a 4.9-fold increase in patients mobilizing ≥ 6 million CD34+ cells/kg with Motixafortide plus G-CSF, indicating significant efficacy. Additionally, 88.3% of patients achieved transplantation after just one apheresis session. The safety profile was also noted as acceptable. BioLineRx aims to submit an NDA for regulatory approval in the first half of 2022.