BioLineRx Ltd. (BLRX) - NASDAQ
  • Tue, Jun. 28, 7:57 AM
    • BioLineRx (NASDAQ:BLRX) announces the filing of regulatory submissions required to commence a Phase 2a trial assessing BL-8040, in combination with Merck's (NYSE:MRKKEYTRUDA (pembrolizumab), for the treatment of pancreatic cancer. The study, called COMBAT, is expected to commence in Q3.
    • The 30-subject, open-label, single-arm study is designed to evaluate the clinical response, safety and tolerability of the combination as well as multiple pharmacodynamic parameters, including the ability to improve infiltration of T cells into the tumor and their reactivity in patients with metastatic pancreatic adenocarcinoma.
    | Tue, Jun. 28, 7:57 AM
  • Tue, May 17, 8:14 AM
    • Biolinerx (BLRX) Q1 results: Revenues: $0; R&D Expense: $2.6M (-18.8%); SG&A: $1.2M (+9.1%); Operating Loss: ($3.8M) (+11.6%); Net Loss: ($3.5M) (+18.6%); Loss Per Share: ($0.06) (+40.0%); Quick Assets: $45M (-5.7%); CF Ops: ($4.2M) (-20.0%).
    • No guidance given.
    | Tue, May 17, 8:14 AM
  • Tue, May 17, 7:18 AM
    • Biolinerx (NASDAQ:BLRX): Q1 EPS of -$0.06 beats by $0.02.
    • Cash and cash equivalents of $4.6M.
    • Press Release
    | Tue, May 17, 7:18 AM | 1 Comment
  • Tue, Mar. 29, 9:30 AM
    • BioLineRx (NASDAQ:BLRX) announces positive results from a Phase 2 clinical trial assessing BL-8040, as monotherapy and in combination with the chemo agent cytarabine, in relapsed/refractory acute myeloid leukemia.
    • The composite complete remission rate, which includes patients with complete remission (CR) and complete remission with incomplete blood count recovery (CRi), was 38% in those who received up to two cycles of BL-8040 at doses of 1 mg/kg or higher (n=15/39). Participants included patients who had undergone a significant number of prior treatments or who failed to respond to induction treatment.
    • BL-8040 was safe and well-tolerated at all doses including the maximum 2.0 mg/kg. No major adverse events were reported (45 subjects).
    • The company plans to discuss the data with regulatory agencies with the aim of clarifying a development path forward.
    • BL-8040 is a synthetic peptide that binds to a protein found on the surface of cancer cells called CXCR4, a chemokine receptor that that plays a key role in tumor growth and survival. CXCR4 is overexpressed in more than 70% of human cancers and is associated with a poor prognosis.
    | Tue, Mar. 29, 9:30 AM | 13 Comments
  • Wed, Mar. 23, 8:45 AM
    • BioLineRx (NASDAQ:BLRX) commences a Phase 2 clinical trial assessing BL-8040 as a single agent to promote stem cell mobilization for allogeneic transplantation. The study will enroll up to 24 donor/recipient pairs, aged 18 - 70. The primary endpoint will measure the ability of a single injection of BL-8040 to mobilize sufficient amounts of cells for transplantation following as many as two leukapheresis collections. For recipients, the study will evaluate the effectiveness of the BL-8040-collected graft.
    • The trial will also assess the safety and tolerability of BL-8040 in healthy donors in addition to graft durability, the incidence of acute graft versus host disease (grade 2 - 4) and other recipient-related measures in patients who have undergone transplantation with BL-8040-mobilized cells.
    • Partial results should be available by the end of the year. Top-line data are expected by the end of 2017. There are no approved drugs for stem cell mobilization to support allogeneic transplant.
    • BL-8040, in development for the treatment of certain blood cancers, is a synthetic peptide that binds to a protein found on the surface of cancer cells called CXCR4, a chemokine receptor that that plays a key role in tumor growth and survival. CXCR4 is overexpressed in more than 70% of human cancers and is associated with a poor prognosis.
    | Wed, Mar. 23, 8:45 AM | 1 Comment
  • Tue, Mar. 15, 9:17 AM
    | Tue, Mar. 15, 9:17 AM | 4 Comments
  • Thu, Mar. 10, 9:55 AM
    • Biolinerx (BLRX -0.87%) FY15 results: Revenues: $0; R&D Expense: $11.5M (-3.4%); SG&A: $4.7M (-13.0%); Operating Loss: ($16.2M) (+6.4%); Net Loss: ($14.4M) (-29.7%); Loss Per Share: ($0.28) (+17.6%); Quick Assets: $47.7M (+37.5%).
    • No guidance given.
    | Thu, Mar. 10, 9:55 AM
  • Thu, Mar. 10, 7:05 AM
    | Thu, Mar. 10, 7:05 AM
  • Tue, Jan. 12, 9:15 AM
    | Tue, Jan. 12, 9:15 AM
  • Tue, Jan. 12, 7:41 AM
    • BioLineRx (NASDAQ:BLRX) and Merck (NYSE:MRK) collaborate in a Phase 2 clinical trial assessing the combination of BioLineRx's BL-8040 and Merck's KEYTRUDA (pembrolizumab) in patients with metastatic pancreatic adenocarcinoma.
    • The trial, expected to commence by mid-year, will be sponsored and conducted by BioLineRx. Both companies have the option to expand the collaboration into a pivotal late-stage trial. Additional details are not disclosed.
    • BL-8040 is a synthetic peptide that binds to a protein found on the surface of cancer cells called CXCR4, a chemokine receptor that that plays a key role in tumor growth and survival. CXCR4 is overexpressed in more than 70% of human cancers and is associated with a poor prognosis.
    • KEYTRUDA helps the immune system fight tumor cells by blocking the interaction between PD-1, a cell surface receptor expressed on T cells and pro-B cells, and its ligands PD-L1 and PD-L2. PD-1 is an immune checkpoint which down regulates the immune system. Blocking its action activates the immune system to attack cancer cells.
    | Tue, Jan. 12, 7:41 AM
  • Dec. 1, 2015, 9:22 AM
    | Dec. 1, 2015, 9:22 AM | 5 Comments
  • Nov. 23, 2015, 12:10 PM
    • BioLineRx (BLRX -3.6%) commences a Phase 1/2 clinical trial assessing lead product candidate BL-8040, in combination with standard-of-care immunosuppressive therapy, for the treatment of hypoplastic myelodysplastic syndrome (hMDS) and aplastic anemia (AA).
    • The open-label study, conducted with MD Anderson Center Center in Houston, TX, will enroll up to 25 patients. The primary endpoint is the safety and tolerability of BL-8040 on top of the standard immunosuppressive regimen of anti-thymocyte globulin, cyclosporine and methylprednisolone. Secondary endpoints will measure response rate, time and duration of response and overall survival. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is July 2017. The estimated study completion date is January 2018.
    • BL-8040 is a short peptide that functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers. Its expression is often correlated with disease severity.
    | Nov. 23, 2015, 12:10 PM | 5 Comments
  • Nov. 16, 2015, 7:40 AM
    • Biolinerx (BLRX) Q3 results: Revenues: $0; R&D Expense: $2.6M (-13.3%); SG&A: $1M (-9.1%); Operating Loss: ($3.6M) (+12.2%); Net Loss: ($1.6M) (-128.6%); Loss Per Share: ($0.03) (-50.0%); Quick Assets: $50.7M (+46.1%); CF Ops: ($11M).
    • No guidance given.
    | Nov. 16, 2015, 7:40 AM
  • Nov. 16, 2015, 7:04 AM
    • Biolinerx (NASDAQ:BLRX): Q3 EPS of -$0.03.
    | Nov. 16, 2015, 7:04 AM
  • Nov. 5, 2015, 9:10 AM
    | Nov. 5, 2015, 9:10 AM | 32 Comments
  • Sep. 9, 2015, 10:29 AM
    • BioLineRx (BLRX -0.9%) announces that commercialization partner Omega Pharma, now part of Perrigo (PRGO +0.1%), has submitted an application for CE Mark clearance for BL-5010, for the non-surgical removal of skin lesions.
    • BL-5010, an over-the-counter medicine, offers a novel method for removing seborrheic keratosis and other skin lesions without surgery and anesthesia. It is applied topically to the lesion which causes it to dry out and fall off within one to four weeks.
    | Sep. 9, 2015, 10:29 AM
Company Description
BioLineRx Ltd. engages in the pharmaceutical industry. It develops pre-clinical and clinical stage therapeutics with specialization in skin lesions, acute myocardial infarction, acute myeloid leukemia and hematological cancers, inflammatory bowel disease, hepatitis C, celiac disease,... More
Sector: Healthcare
Industry: Biotechnology
Country: Israel