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BioLineRx Ltd. (BLRX)

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Last Post: 1/17/2019 12:19:00 PM - Followers: 108 - Board type: Free - Posts Today: 0

BIOLINERX
BioLineRx is a clinical-stage, publicly-traded (NASDAQ/ TASE: BLRX) biopharmaceutical development company based in Jerusalem, Israel.
The Company develops products suitable for the pharmaceutical market satisfying an unmet medical need or exhibiting advantages over current therapies.

BioLineRx's close ties with universities, research institutes, academic institutions, technology transfer offices and biotechnology companies, both in Israel and globally, enable access to promising projects at an early stage. The first stage involves a stringent selection process. BioLineRx's scientists specialize in evaluating potential drug candidates from both scientific and marketing perspectives. After acquiring the most promising projects, the Company then performs feasibility assessment studies and development through pre-clinical and clinical stages. Supported and assisted by a distinguished panel of scientific advisers, the Company's scientists and experts in pharmacy and regulation, clinical trials and IP work together to advance BioLineRx’s pipeline usually through Phase II proof of concept in humans. And finally, the Company partners with medium size and large pharmaceutical companies to complete the clinical development and bring the product to market.
 
BioLineRx also operates BioLine Innovations Jerusalem (BIJ) a biotechnology incubator for the development of pre-clinical therapeutic candidates, and an Early Development Program (EDP) dedicated to identifying and advancing promising early stage programs.

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HIGHLIGHTS:: BioLineRx Ltd.(BLRX)

BL-7040 (IBD) – Received positive results from a Phase 2 proof-of-concept study to evaluate the effectiveness of BL-7040 for the treatment of inflammatory bowel disease (IBD)

Immediate next steps include evaluating the most advantageous ways to progress with this therapeutic candidate from a clinical and business perspective, including examining potential additional indications. Plans also include accelerating discussions with potential co-development and licensing partners.

BL-8040 (AML) – Received U.S. regulatory approvals to commence a Phase 2a trial for the treatment of relapsed/refractory acute myeloid leukemia (AML); trial to be conducted at three sites in the U.S. and five sites in Israel, with initial patient enrollment expected in Q2 2013; partial results expected in Q4 2013 and final results expected in the second half of 2014

BL-1040 (ventricular remodeling) – Recruitment commenced at U.S. sites for the PRESERVATION I clinical trial, a CE Mark registration trial for BL-1040 (BCM), a novel medical device for the prevention of ventricular remodeling following an acute myocardial infarction; there are currently multiple active sites recruiting in six countries

BL-5010 (skin lesions) – Reached final stages of development for proprietary pen-like applicator for BL-5010, a novel formulation of two acids being developed for the non-surgical removal of skin lesions; planning to commence pivotal CE-Mark registration trial for European approval in the second half of 2013

BL-8020 (HCV) – Commenced a Phase 1/2 clinical trial to evaluate the effectiveness of an orally-available, interferon-free treatment for Hepatitis C (HCV) at two sites in France, following approval from the French regulatory authorities; partial results expected in Q4 2013; final results expected in the first half of 2014

BL-1020 (schizophrenia) – Disappointing results of interim analysis for the Phase 2/3 CLARITY trial led to termination of the trial; full unblinded study data is expected during Q3 2013

BL-9010 (severe asthma) – Added a novel, bi-specific antibody for the treatment of severe and persistent asthma to the main therapeutic pipeline, following promising pre-clinical data

Capital Raise – $8 million direct equity placement to the OrbiMed Group was completed in February 2013


“In the past few months, we have seen major progress on a number of clinical and pre-clinical programs in our pipeline, which offer exciting opportunities to address unmet medical needs in a wide range of therapeutic areas. We believe our active programs offer significant potential for patients around the world, as well as for the future success of our Company and its shareholders,” stated Kinneret Savitsky, Ph.D, Chief Executive Officer of BioLineRx. “In the third quarter of this year, we expect to receive a full analysis of the unblinded study data for all participants in the CLARITY Phase 2/3 trial for BL-1020. While we discontinued this clinical trial in mid-March based on disappointing results of the interim analysis, we will not decide the future of the overall BL-1020 program until we have carried out a more thorough review of the full unblinded results.”

“The PRESERVATION I study being conducted by our partner, Ikaria, for BL-1040, for the treatment of ventricular remodeling post-AMI, is moving forward at full steam, with multiple sites in six countries around the world actively recruiting, including a number of sites in the U.S. BL-1040 remains one of our leading compounds, with significant clinical data expected to be reported next year, and we hope that it will eventually offer a great benefit to heart attack patients,” continued Dr. Savitsky.

“We continue to accelerate development of our clinical pipeline, with three of our compounds completing significant milestones since the beginning of the year. Our BL-7040 compound for IBD completed a Phase 2a open-label, proof-of-concept study with very encouraging and positive results. We are now evaluating next steps for BL-7040 in order to identify the best way to move forward from both a clinical and business perspective, including examining potential additional indications. In parallel, we are also planning to accelerate discussions with potential co-development and licensing partners for this asset.”

“In addition, BL-8040, for hematological cancers, one of our most exciting programs, just received FDA approval to commence a Phase 2a trial for the treatment of relapsed/refractory AML. We are excited to initiate this multicenter, open-label study under an IND, which will be conducted in the U.S. and Israel, and will enroll up to 50 patients. MD Anderson Cancer Center in Houston will be the initial site for this trial, with two additional premier sites in the US and five other well-known sites in Israel expected to participate. We believe the excitement surrounding the trial, especially at these particular sites, is a testament to the need for an AML therapy, as well as the potential of BL-8040 shown in the previous pre-clinical and clinical data.”

“Finally, we recently reported enrollment of the first patient in our Phase 1/2 trial for BL-8020, an oral treatment for HCV, at a leading hospital in Paris, France. We look forward to partial results from the trial in the fourth quarter of 2013, as well as final results in the first half of 2014. I would also like to point out that as our pipeline evolves, we continue to replenish our pre-clinical pipeline with the addition of promising assets, such as BL-9010 for the treatment of severe and persistent asthma, which recently graduated from our Early Development Program,” concluded Dr. Savitsky



Link To Interview with BioLineRX VP Of Business Development:
http://www.pharmatelevision.com/Video/1176-PTVNRDavidMalek.aspx



biolinerx.com -  BioLineRX Website




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BLRX News: Securities Registration (foreign Private Issuer) (f-3) 12/26/2018 04:13:29 PM
BLRX News: Report of Foreign Issuer (6-k) 12/11/2018 07:01:55 AM
BLRX News: Report of Foreign Issuer (6-k) 12/04/2018 07:01:47 AM
BLRX News: Report of Foreign Issuer (6-k) 11/20/2018 07:02:14 AM
BLRX News: Report of Foreign Issuer (6-k) 11/08/2018 07:02:21 AM
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#1912  Sticky Note BioLineRX +12% after FDA grants biological product designation TAB78 11/23/18 09:17:56 AM
#1943   Thank you Boo- this is set up long top123 01/17/19 12:19:00 PM
#1942   Welcome aboard Top. You have 2 followers, I'm BooDog 01/17/19 07:41:04 AM
#1941   Hello all- Took very large position @.43-44, like top123 01/16/19 12:16:44 PM
#1940   Nice little run up today. Tax selling is PennyWorld 01/10/19 06:20:42 PM
#1939   What a diluting POS they need money definitely Axeman 12/28/18 02:24:51 PM
#1938   me too, : ) if I am wrong TAB78 12/28/18 10:30:46 AM
#1937   I hope you are right.EOM PennyWorld 12/28/18 10:26:28 AM
#1936   I understand the concern, but IMO I think TAB78 12/28/18 10:24:53 AM
#1935   I find that PR interesting. However, it mentions PennyWorld 12/28/18 10:12:49 AM
#1934   I am piecing together the R/S you mentioned, TAB78 12/28/18 09:56:38 AM
#1933   Don't know the answers to to your questions, TAB78 12/28/18 12:13:13 AM
#1932   All I care about is the R/S. I'm PennyWorld 12/27/18 08:38:49 PM
#1931   I do not see a r/s in the TAB78 12/27/18 08:09:07 PM
#1930   About 106 million outstanding with the F-3 tone3 12/27/18 06:02:23 PM
#1929   Was the last R/S in June, 2015? PennyWorld 12/27/18 04:09:07 PM
#1928   FORM F-3 Filed, 12/26/18 https://investorshub.advfn.com/secure/post_new.a TAB78 12/27/18 02:30:59 PM
#1927   Dec 12th, 2018 // No Comments PennyWorld 12/21/18 08:21:36 AM
#1926   Per MarketBeat, there are a ton of 'buy' PennyWorld 12/20/18 09:20:18 AM
#1925   TRIPLE COMBINATION ARM.. I think this is scaring PennyWorld 12/19/18 06:27:09 PM
#1924   I'm averaging down on this one. Big presentation PennyWorld 12/07/18 02:17:42 PM
#1923   BLRX book/sh 0.38ish cent, love to add cheapies doprider 12/07/18 01:06:43 PM
#1922   on radar, 11th dec investor lunch and next doprider 12/06/18 08:06:29 PM
#1921   the Company has a grace period of 180 BooDog 12/04/18 09:25:44 AM
#1920   Big Gains will happen with FDA approves the PennyWorld 11/24/18 08:29:59 PM
#1919   Cancer space has become too competitive and it Amatuer17 11/24/18 06:54:13 PM
#1918   I agree, I am here for the same TAB78 11/23/18 11:11:19 PM
#1917   Yes, that would be the ticket. BooDog 11/23/18 09:22:14 PM
#1916   All of the assumed that the FDA gives PennyWorld 11/23/18 07:58:40 PM
#1915   Think this is an excellent milestone and we'll BooDog 11/23/18 01:51:30 PM
#1914   I posted the summary sheet of your article, TAB78 11/23/18 09:23:54 AM
#1913   Form 6-K TAB78 11/23/18 09:20:22 AM
#1912   BioLineRX +12% after FDA grants biological product designation TAB78 11/23/18 09:17:56 AM
#1911   one would think that this is good news TAB78 11/23/18 09:11:02 AM
#1910   WELL A NEW LOW . I SHOULD OF sell sell 11/20/18 10:18:19 PM
#1909   News: BioLineRx Announces Receipt of FDA Biological Product BooDog 11/20/18 07:15:46 AM
#1908   Everything is so far in terms of key Amatuer17 11/11/18 07:09:35 AM
#1907   Conference call quotes. Why this didn't jump to BarrellofHay 11/09/18 02:11:55 PM
#1906   THE ENGINE STARTING TO SMOKE , ITS GOING sell sell 11/09/18 11:14:49 AM
#1905   That seller is finally out so we're basing Axeman 11/07/18 03:46:13 PM
#1904   When $0.60? Zaks94 11/07/18 11:00:12 AM
#1903   And 60s are here this thing as flatlined Axeman 10/30/18 11:26:39 AM
#1902   It keeps breaking support until it gets back Axeman 10/28/18 09:51:44 PM
#1901   it will settle and then peeps will start TAB78 10/28/18 07:51:55 AM
#1900   HI HO - HI HO -ITS OFF TO sell sell 10/28/18 01:29:40 AM
#1899   Next stop $0.60 unfortunately reminds me of when Axeman 10/27/18 03:42:13 PM
#1898   IMO - All is good, just peeps who TAB78 10/26/18 12:39:03 PM
#1897   look at the 2 year chart. Incumbent SH PennyWorld 10/26/18 10:54:42 AM
#1896   Yes..falling knife continues. Axeman 10/26/18 10:40:39 AM
#1895   Ditto. Averaging down here (scaling in). No PennyWorld 10/26/18 10:31:36 AM
#1894   Bought close to low sing all indicators way Axeman 10/25/18 11:23:35 PM
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