Welcome to our dedicated page for BioLineRX news (Ticker: BLRX), a resource for investors and traders seeking the latest updates and insights on BioLineRX stock.
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) 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.
BioLineRx Ltd. (NASDAQ: BLRX) announced the presentation of a poster at the AACR Annual Meeting, detailing a Phase 2a study of motixafortide in combination with KEYTRUDA and chemotherapy for metastatic pancreatic cancer. The study, which evaluated 38 patients, highlighted the challenges faced by patients with liver metastases. Key findings include a median overall survival (mOS) of 6.5 months and an overall response rate (ORR) of 21.1%. The company aims to advance discussions for potential collaborations and anticipates final data from a Phase 3 study in stem cell mobilization soon.
BioLineRx Ltd. (NASDAQ: BLRX) reported its financial results for 2020, highlighting positive interim data from its GENESIS Phase 3 trial of motixafortide for stem-cell mobilization, leading to early enrollment cessation. The firm anticipates NDA submission in the first half of 2022. Additionally, the triple combination study of motixafortide with KEYTRUDA and chemotherapy demonstrated improved outcomes in stage IV pancreatic cancer. The year ended with a net loss of $30 million, but the company bolstered its finances with $34.5 million from a public offering, supporting continued development of motixafortide and AGI-134.
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