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March 10, 2014
07:02 EDTBLRXBioLineRx completes dose escalation stage of study for celiac treatment
BioLineRx’s novel treatment for celiac disease, BL-7010, has successfully completed the single administration, dose-escalation stage of the on-going Phase 1/2 clinical study. No serious adverse events were reported and there were no dose-limiting safety issues. Based on these positive safety and tolerability results, the Company will proceed with the repeated administration stage of the study. Results are expected in mid-2014. The Phase 1/2 study, taking place at Tampere Hospital in Finland is a two-part, double-blind, placebo-controlled, dose escalation study of BL-7010 in up to 24 well-controlled celiac patients. The primary objective of the study is to assess the safety of single and repeated ascending doses of BL-7010 in the study patients. Secondary objectives include an assessment of the systemic exposure, if any, of BL-7010 in the patients. During the first part of the study, six dose levels of BL-7010 were evaluated compared to placebo. The escalation stage reached the highest planned dose, and although the study remains blinded at this point, no serious or dose-limiting adverse events were reported.
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December 23, 2014
16:02 EDTBLRXBioLineRx out-licenses novel skin lesion treatment to Omega Pharma
BioLineRx announced that it has entered into an exclusive out-licensing agreement with Omega Pharma for the rights to BioLineRx’s BL-5010, a novel product for the non-surgical removal of benign skin lesions, for OTC indications in the territory of Europe, Australia and additional selected countries. BioLineRx will retain the rights to BL-5010 in the United States and the rest of the world. This licensing agreement significantly accelerates the pathway to commercialization for this asset, with the first OTC products expected to enter the market in 2016. Under the terms of the agreement, Omega Pharma will be responsible for all development activities required to obtain regulatory approval in the licensed territory for at least two OTC indications. In addition, Omega Pharma will sponsor and manufacture the product in the relevant regions, and will have exclusive responsibility for commercialization. The specific financial terms of the licensing agreement were not disclosed. Omega Pharma will pay BioLineRx an undisclosed amount for each unit sold and BioLineRx will be entitled to certain commercial milestone payments. In addition, BioLineRx will have full access to all clinical and R&D data generated during the performance of the development plan and may use these data in order to develop and/or license the product in other territories and fields of use where it retains the rights.
December 22, 2014
06:08 EDTBLRXNovartis reports 12.8% passive stake in BioLineRx
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December 16, 2014
07:06 EDTBLRXBioLineRx and Novartis enter into strategic collaboration agreement
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December 15, 2014
09:18 EDTBLRXBioLineRx price target raised to $10.50 from $8 at Roth Capital
Roth Capital raised its price target on BioLineRx as the firm thinks the company showed the ability of its BL-8040 drug to affect the tumor microenvironment and regulate the apoptosis of tumor cells during its Investor Day. The firm keeps a Buy rating on the shares.

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