Last 68.30
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biolinerx ltd (BLRX) Details

BioLineRx Ltd., a clinical stage biopharmaceutical development company, is engaged in identifying, in-licensing, and developing therapeutic candidates that address unmet medical needs. The company’s development pipeline consists of clinical-stage therapeutic candidates, including BL-1040, a resorbable polymer solution being developed to reduce or prevent the ventricular remodeling; BL-8040, a peptide for the treatment of acute myeloid leukemia, stem cell mobilization, and other hematological indications; BL-7010, a polymer for the treatment of celiac disease; BL-5010, which is being developed as a medical device for the non-surgical removal of benign skin lesions; BL-7040, an oligonucleotide for the treatment of inflammatory bowel disease; and BL-8020, an orally available treatment for the Hepatitis C virus and other viral indications. It also has three therapeutic candidates in the preclinical stages of development, such as BL-8030 for the treatment of Hepatitis C; BL-9010 to treat severe allergies/asthma; and BL-9020 for the treatment of type 1 diabetes. BioLineRx Ltd. was founded in 2003 and is headquartered in Jerusalem, Israel.

43 Employees
Last Reported Date: 03/17/14
Founded in 2003

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biolinerx ltd (BLRX) Key Developments

BioLineRx, Ltd. Announces Results from Phase 1/2 Study for Celiac Treatment

BioLineRx, Ltd. announced unblinded results from it's phase 1/2 study for BL-7010, a novel polymer for the treatment of celiac disease. The phase 1/2 study, taking place at Tampere Hospital in Finland is a two-part (single and repeated administration), double-blind, placebo-controlled, dose escalation study of BL-7010 in up to 32 well-controlled celiac patients. The primary objective of the study is to assess the safety of single and repeated ascending doses of BL-7010. Secondary objectives include an assessment of the systemic exposure, if any, of BL-7010. During the single-administration part of the study, six dose levels of BL-7010 were evaluated compared to placebo in a 6+2 standard design, with six patients on BL-7010 and two patients on placebo. This escalation stage reached the planned dose with no serious or dose-limiting adverse events. All planned doses were safe and well-tolerated with all patients completing this part of the study. During the second, repeated-administration part of the study, each patient received either 3 grams of BL-7010 or placebo for 14 days, three times per day, in the same 6+2 standard design. BL-7010 was well-tolerated over 14 days of treatment, with only one patient not completing the 14-day treatment period. Gastrointestinal-related adverse events (primarily diarrhea) were reported in six out of eight patients, though none were considered serious or dose-limiting and were also observed in one of the two patients on placebo. In light of these findings, and based on pre-clinical studies where the efficacious dose is predicted to be lower than the dose tested in the repeated administration stage of the study, the company intends to further investigate lower repeated doses of BL-7010 in order to select the optimal dose for the upcoming efficacy study, which is expected to commence in early 2015.

BioLineRx, Ltd. In-Licenses BL-1110 Novel Compound for Treatment of Neuropathic Pain

BioLineRx Ltd. announced it has in-licensed BL-1110, a novel compound for the treatment of neuropathic pain. BL-1110 may also be developed for the treatment of scleroderma, an autoimmune disease characterized by a hardening and tightening of the skin and connective tissues. The compound, which had been previously developed as part of BioLineRx's Early Development Program under the name EDP-34, was in-licensed from the University of Colorado. Neuropathic pain is caused by damage or diseases affecting the nervous system, and usually does not respond well to regular painkillers. One of the most potent drugs for the treatment of neuropathic pain is morphine; however, its efficacy is often significantly limited due to the body's development of tolerance to the drug, as well as its severe side effects. Morphine can create neuroinflammation in the central nervous system, which has been linked to the suppression of morphine analgesia, as well as the enhancement of morphine-induced tolerance, dependence and reward associated with drug abuse. Recent studies show part of these neuroinflammatory effects are triggered by the interaction of morphine with glial cells, which are highly prevalent in the central nervous system. BL-1110, which was invented by Prof. Linda R. Watkins from the Psychology and Neuroscience Department, and Prof. Hang Hubert Yin from the Chemistry and Biochemistry Department both from the University of Colorado at Boulder, blocks the interaction of morphine with glial cells, thereby enhancing the analgesic effect of morphine, and reducing concurrent adverse effects and inflammatory processes. BL-1110 is a small molecule that targets the critical TLR4/MD-2 complex formation, thus preventing the binding of morphine to the TLR4 receptor in glial cells. BL-1110 is administered orally, together with morphine or other opioids. In preclinical studies in rats, BL-1110 was shown to enhance the effects of morphine. Furthermore, the studies show the drug penetrates the blood-brain barrier and reaches the central nervous system with high efficiency, that it is safe for use and that it does not induce adverse effects at doses that are much higher than the effective dose. BL-1110 works through a novel mechanism-of-action, based on recent discovery that opioids, such as morphine, cause the activation of glial cells. This glial activation results in the release of pro-inflammatory factors, which suppress the desired opioid-induced neuronal analgesic effect, thereby reducing the efficacy of the opioid.

BioLineRx Ltd. Receives Approval from Israeli Ministry of Health to Commence Phase 1 Trial for BL-8040

BioLineRx Ltd. announced that it has received approval from the Israeli Ministry of Health to commence a Phase 1 trial for BL-8040, a novel treatment for the mobilization of stem cells from the bone marrow to the peripheral blood circulation. The study is expected to commence during the third quarter of 2014 at Hadassah Medical Center in Jerusalem. The Phase 1 study consists of two parts. Part 1 is a randomized, double-blind, placebo-controlled dose escalation study exploring the safety and tolerability of escalating repeated doses of BL-8040 in healthy volunteers. Secondary objectives include assessment of the efficacy of BL-8040 in mobilizing stem cells as a stand-alone therapy, as well as determining the pharmacokinetic profile of the drug. This part will be performed in up to 4 cohorts, with 8 healthy volunteers in each cohort. Part 1 of the study will serve to select the optimal safe and efficacious dose of BL-8040 to be used as a stand-alone therapy in Part 2 of the study. Part 2 is an open-label study designed to assess BL-8040’s stem cell mobilization capacity, as well as the yield of cells collected by apheresis. Secondary endpoints of the study include evaluation of the viability and biological activity of cells mobilized by BL-8040 and collected by apheresis. This part will be performed in a single cohort of 8 healthy volunteers who will receive the selected dose regimen of BL-8040 based on the data from Part 1.


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