BiolineRx Overview
BioLineRx is a clinical-stage biopharmaceutical company focused on oncology. The company's pipeline currently consists of BL-8040, a platform for multiple cancer and hematological indications; and AGI-134, a synthetic immunotherapy in development for solid tumors. The BioLineRx pipeline is generated by systematically identifying, validating, and in-licensing therapeutic candidates with advantages over current therapies or that address unmet medical needs. BioLineRx also works with Novartis on the codevelopment of selected Israel-sourced novel drug candidates and has recently signed a collaboration agreement with MSD (known as Merck in the United States and Canada) to run a phase-2a study in pancreatic cancer using a combination of BL-8040 and Merck's Keytruda. BioLineRx has received the FDA biological product designation for its novel cancer immunotherapy candidate AGI-134. In January 2020, the company announced that the European Commission had granted orphan drug designation to its lead oncology candidate, Motixafortide (BL-8040), for the treatment of pancreatic cancer.
Cumulative Funding Raised Over Time ($)
$20.0MApr 2024
$26.0MApr 2024
$34.0MFeb 2013
$44.0MJan 2025
$53.6MJul 2017
$58.0MJun 2020
$62.0MMay 2004
$71.0MMay 2020
$80.0MNov 2024
$89.0MSep 2005
$104.0MSep 2022
$124.0MSep 2022
Latest News
growth-positive
BLRX: A Venture into GBM
BioLineRx Ltd. has entered into a joint venture with Hemispherian AS to develop a new cancer drug, GLIX1, which targets DNA repair vulnerabilities in cancer cells. The joint venture will focus on the clinical evaluation and commercialization of GLIX1, with Hemispherian holding 60% ownership and BioLineRx holding 40%. The drug has already received FDA clearance for its investigational new drug application, and a Phase I/IIa study is expected to begin in the first quarter of 2026. BioLineRx will invest $5 million into the joint venture over 36 months and may increase its equity stake by making additional investments.
Product StagePartnersInvestment
growth-positive
BioLineRx Ltd. and Hemispherian AS Establish Joint Venture to Develop GLIX1, a First-in-Class, Oral, Small Molecule Targeting DNA Damage Response in Glioblastoma and Other Cancers
BioLineRx Ltd., a clinical development stage biopharmaceutical company, has announced a joint venture with Hemispherian AS to develop GLIX1, a small molecule targeting DNA damage response in glioblastoma and other cancers. GLIX1 has shown promising results in preclinical studies, including potent anti-tumor activity and excellent blood-brain barrier penetration. The U.S. FDA has cleared an IND application for a Phase 1/2a study, expected to begin in Q1 2026. The drug has also received Orphan Drug Designation from both the FDA and EMA. This collaboration aims to address the unmet need for new glioblastoma treatments.
Product StagePartners
growth-positive
- GLIX1 restores TET2 activity in cancer, resulting in double stranded DNA breaks in cancer cells only - - FDA IND clearance received for Phase 1/2a study,...
BioLineRx Ltd., a biopharmaceutical company, has announced a joint venture with Hemispherian AS to develop GLIX1, a small molecule targeting DNA damage response in glioblastoma and other cancers. The joint venture aims to leverage BioLineRxs clinical and regulatory expertise and Hemispherians research capabilities. GLIX1 has shown promising preclinical results and has received FDA IND clearance, with a Phase 1/2a study expected to start in Q1 2026. The glioblastoma market is projected to exceed $3.8 billion annually by 2030. BioLineRx will manage and fund the development activities, holding a 40% stake in the JV, which could increase to 70% with further investment.
Product StagePartners
growth-negative
BLRX: ASCO Poster & Abstract
BioLineRx Ltd. reported its second quarter 2025 financial results, highlighting a net loss of $3.9 million. The company is focusing on replenishing its pipeline following the transition of Aphexda commercialization to Gamida Cell. BioLineRx is evaluating new development assets and plans to announce them by year-end. The partnership with Columbia University is advancing a study on pancreatic ductal adenocarcinoma, with promising results presented at the ASCO meeting. The company reported $0.3 million in license revenues, a significant decrease from the previous year. The financial results were announced on August 14, 2025.
Product StagePartners
growth-positive
BioLineRx Reports Second Quarter 2025 Financial Results and Provides Corporate Update
BioLineRx Ltd., a biopharmaceutical company, reported its financial results for Q2 2025 and provided a corporate update. The company is focused on expanding its pipeline in oncology and rare diseases, leveraging its clinical and regulatory expertise. BioLineRx has a strong balance sheet with $28.2 million, extending its cash runway into H1 2027. The company is progressing in discussions with potential partners for pipeline expansion, targeting a transaction by 2025. The CheMo4METPANC Phase 2b clinical trial, led by Columbia University and supported by Regeneron and BioLineRx, is evaluating motixafortide in combination with cemiplimab and standard chemotherapy. Interim analysis and promising patient outcomes were highlighted at the 2025 ASCO Annual Meeting.
Product StagePartners
| Sector | Health Tech & Life Sciences |
Funding
| Total funding | $208.64M |
| Last funding | $10M |
| Stage | Public |
| Rounds | 18 |
| Investors | 10 |
Team Members
2
Employees: 51-200
Web & Social Links
| Website | biolinerx.com |
| Careers | Careers page |
Locations
HaMa'ayan Street 2, Modi'in-Maccabim-Re'ut, Israel
Photos & Videos
2 item(s)
BiolineRx Business
Business models
B2B
Product stage
Clinical Trial
Employees
51-200
Sector
Health Tech & Life SciencesPharma & Medical BiotechnologyDrugs Discovery & DevelopmentTarget Customer
Healthcare & Life SciencesLife SciencesPharmaceuticalsCore Technology
BiologicalsTags (9)
viral-diseasescancerinflammatory-diseasespharma-companiesdrug-discoverypharmaceuticalscancer-therapyimmunotherapyoncologyGeographic Markets
United StatesBiolineRx Financials
$208.64M
Total funding
Undisclosed
Capital raised
$10M
Last funding
Public
Funding stage
18
Total rounds
10
Investors
Cumulative Funding Raised Over Time ($)
$20.0MApr 2024
$26.0MApr 2024
$34.0MFeb 2013
$44.0MJan 2025
$53.6MJul 2017
$58.0MJun 2020
$62.0MMay 2004
$71.0MMay 2020
$80.0MNov 2024
$89.0MSep 2005
$104.0MSep 2022
$124.0MSep 2022
Private Equity Funding
PIPE
Jan 2025
$10M
PIPE
Nov 2024
$9M
Highbridge Capital Management (Lead)
Debt Financing
Apr 2024
$20M
Kreos Capital
PIPE
Apr 2024
$6M
Undisclosed Investor(s)
PIPE
Sep 2022
$15M
Undisclosed Investor(s)
Debt Financing
Sep 2022
$20M
Kreos Capital (Lead)
PIPE
Jun 2020
$4.39M
Undisclosed Investor(s)
PIPE
May 2020
$9M
Undisclosed Investor(s)
PIPE
Jul 2017
$9.6M
BVF Partners (Lead)
PIPE
Feb 2013
$8M
OrbiMed
Seed
Sep 2005
$9M
Pitango VC, Teva Pharmaceutical Industries, Giza Venture Capital
Pre-Seed
May 2004
$4M
Yehuda Zisapel (Late), Star Ventures
Public Offering / Exit
POEvent
Jan 2021
Undisclosed
POEvent
Feb 2019
Undisclosed
POEvent
Apr 2017
Undisclosed
POEvent
Mar 2015
Undisclosed
POEvent
Mar 2014
Undisclosed
POEvent
Apr 2007
Undisclosed
Mergers & Acquisitions
MNAEvent
Mar 2017
$6M
BiolineRx Lifecycle
Cumulative Funding Raised Over Time
$20.0MApr 2024
$26.0MApr 2024
$34.0MFeb 2013
$44.0MJan 2025
$53.6MJul 2017
$58.0MJun 2020
$62.0MMay 2004
$71.0MMay 2020
$80.0MNov 2024
$89.0MSep 2005
$104.0MSep 2022
$124.0MSep 2022
All Events
PIPE
Jan 2025
$10M
PIPE
Nov 2024
$9M
Highbridge Capital Management (Lead)
Debt Financing
Apr 2024
$20M
Kreos Capital
PIPE
Apr 2024
$6M
Undisclosed Investor(s)
PIPE
Sep 2022
$15M
Undisclosed Investor(s)
Debt Financing
Sep 2022
$20M
Kreos Capital (Lead)
PIPE
Jun 2020
$4.39M
Undisclosed Investor(s)
PIPE
May 2020
$9M
Undisclosed Investor(s)
PIPE
Jul 2017
$9.6M
BVF Partners (Lead)
PIPE
Feb 2013
$8M
OrbiMed
Seed
Sep 2005
$9M
Pitango VC, Teva Pharmaceutical Industries, Giza Venture Capital
Pre-Seed
May 2004
$4M
Yehuda Zisapel (Late), Star Ventures
POEvent
Jan 2021
Undisclosed
POEvent
Feb 2019
Undisclosed
POEvent
Apr 2017
Undisclosed
POEvent
Mar 2015
Undisclosed
POEvent
Mar 2014
Undisclosed
POEvent
Apr 2007
Undisclosed
MNAEvent
Mar 2017
$6M
BiolineRx News
123 articles
growth-positive
BLRX: A Venture into GBM
BioLineRx Ltd. has entered into a joint venture with Hemispherian AS to develop a new cancer drug, GLIX1, which targets DNA repair vulnerabilities in cancer cells. The joint venture will focus on the clinical evaluation and commercialization of GLIX1, with Hemispherian holding 60% ownership and BioLineRx holding 40%. The drug has already received FDA clearance for its investigational new drug application, and a Phase I/IIa study is expected to begin in the first quarter of 2026. BioLineRx will invest $5 million into the joint venture over 36 months and may increase its equity stake by making additional investments.
Product StagePartnersInvestment
growth-positive
BioLineRx Ltd. and Hemispherian AS Establish Joint Venture to Develop GLIX1, a First-in-Class, Oral, Small Molecule Targeting DNA Damage Response in Glioblastoma and Other Cancers
BioLineRx Ltd., a clinical development stage biopharmaceutical company, has announced a joint venture with Hemispherian AS to develop GLIX1, a small molecule targeting DNA damage response in glioblastoma and other cancers. GLIX1 has shown promising results in preclinical studies, including potent anti-tumor activity and excellent blood-brain barrier penetration. The U.S. FDA has cleared an IND application for a Phase 1/2a study, expected to begin in Q1 2026. The drug has also received Orphan Drug Designation from both the FDA and EMA. This collaboration aims to address the unmet need for new glioblastoma treatments.
Product StagePartners
growth-positive
- GLIX1 restores TET2 activity in cancer, resulting in double stranded DNA breaks in cancer cells only - - FDA IND clearance received for Phase 1/2a study,...
BioLineRx Ltd., a biopharmaceutical company, has announced a joint venture with Hemispherian AS to develop GLIX1, a small molecule targeting DNA damage response in glioblastoma and other cancers. The joint venture aims to leverage BioLineRxs clinical and regulatory expertise and Hemispherians research capabilities. GLIX1 has shown promising preclinical results and has received FDA IND clearance, with a Phase 1/2a study expected to start in Q1 2026. The glioblastoma market is projected to exceed $3.8 billion annually by 2030. BioLineRx will manage and fund the development activities, holding a 40% stake in the JV, which could increase to 70% with further investment.
Product StagePartners
growth-negative
BLRX: ASCO Poster & Abstract
BioLineRx Ltd. reported its second quarter 2025 financial results, highlighting a net loss of $3.9 million. The company is focusing on replenishing its pipeline following the transition of Aphexda commercialization to Gamida Cell. BioLineRx is evaluating new development assets and plans to announce them by year-end. The partnership with Columbia University is advancing a study on pancreatic ductal adenocarcinoma, with promising results presented at the ASCO meeting. The company reported $0.3 million in license revenues, a significant decrease from the previous year. The financial results were announced on August 14, 2025.
Product StagePartners
growth-positive
BioLineRx Reports Second Quarter 2025 Financial Results and Provides Corporate Update
BioLineRx Ltd., a biopharmaceutical company, reported its financial results for Q2 2025 and provided a corporate update. The company is focused on expanding its pipeline in oncology and rare diseases, leveraging its clinical and regulatory expertise. BioLineRx has a strong balance sheet with $28.2 million, extending its cash runway into H1 2027. The company is progressing in discussions with potential partners for pipeline expansion, targeting a transaction by 2025. The CheMo4METPANC Phase 2b clinical trial, led by Columbia University and supported by Regeneron and BioLineRx, is evaluating motixafortide in combination with cemiplimab and standard chemotherapy. Interim analysis and promising patient outcomes were highlighted at the 2025 ASCO Annual Meeting.
Product StagePartners
growth-positive
BioLineRx to Report Second Quarter 2025 Results on August 14, 2025
BioLineRx Ltd., a biopharmaceutical company focused on oncology and rare diseases, announced it will release its unaudited financial results for Q2 2025 on August 14, 2025. The company will host a conference call featuring CEO Philip Serlin. BioLineRxs first approved product, APHEXDA® (motixafortide), is used for stem cell mobilization in multiple myeloma and is being developed and commercialized by Ayrmid Ltd. and Gloria Biosciences. The company is leveraging its expertise in development, regulatory affairs, manufacturing, and commercialization to advance its pipeline.
Product StagePartners
growth-positive
/PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare...
BioLineRx Ltd., a biopharmaceutical company focused on oncology and rare diseases, announced it will release its unaudited financial results for Q2 2025 on August 14, 2025. The company will host a conference call featuring CEO Philip Serlin. BioLineRxs first approved product, APHEXDA® (motixafortide), is used for stem cell mobilization in multiple myeloma and is being developed and commercialized by Ayrmid Ltd. and Gloria Biosciences. The company is leveraging its expertise in development, regulatory affairs, manufacturing, and commercialization to advance its pipeline.
Product StageCustomersPartners
growth-positive
H.C. Wainwright Reaffirms Buy on BioLineRx Ltd. (BLRX) After ASCO 2025
BioLineRx Ltd. (NASDAQ:BLRX) is highlighted as a promising growth stock, with H.C. Wainwright maintaining a Buy rating and a price target of $26.00. The company presented promising data from its CheMo4METPANC Phase 2 trial at ASCO 2025, showing significant efficacy and disease control rates. The trial results have set the stage for a larger randomized Phase 2 study. Additionally, BioLineRx was recently added to the Russell Microcap Index, further solidifying its market presence. The company, a commercial-stage biopharmaceutical entity, focuses on oncology and rare diseases. Despite its potential, some analysts suggest that certain AI stocks might offer better short-term returns.
Product StagePublic Trading
growth-positive
BioLineRx upgraded to Buy from Hold at JonesResearch
BioLineRx has been upgraded to a Buy rating from Hold by JonesResearch, with a price target of $12. This upgrade follows the announcement of new pilot phase data from a Phase II combination trial involving motixafortide, a PD-1 inhibitor, and chemotherapy for first-line pancreatic cancer. The trial showed promising results, with 7 out of 11 patients responding to therapy and 10 achieving disease control. These results suggest potential for BioLineRx to either partner the asset or fund a pivotal trial, assuming favorable Phase II outcomes. The company is expected to experience favorable stock momentum due to these developments.
Product StagePartners
growth-positive
/PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare...
BioLineRx Ltd., a biopharmaceutical company, announced promising results from the pilot phase of their CheMo4METPANC Phase 2 clinical trial. The trial evaluates the combination of motixafortide, cemiplimab, and standard chemotherapies in treating pancreatic cancer. Results showed a 64% overall response rate and a 91% disease control rate, significantly higher than historical data with standard treatments. Four out of eleven patients remained progression-free after more than a year, with two patients undergoing definitive treatment. The trial, supported by Columbia University and Regeneron, will expand to 108 patients and is expected to complete enrollment by 2027. These findings suggest potential improvements in patient outcomes and highlight the therapeutic promise of motixafortide in oncology.
Product StagePartners
growth-positive
BioLineRx Announces New Pilot Phase Data from Phase 2 Combination Trial of Motixafortide in First-Line Pancreatic Cancer (PDAC) to be Presented at ASCO 2025 Annual Meeting
BioLineRx Ltd., a biopharmaceutical company, announced promising results from the pilot phase of its CheMo4METPANC Phase 2 clinical trial at the 2025 ASCO Annual Meeting. The trial evaluates the combination of motixafortide, cemiplimab, and standard chemotherapies in treating pancreatic cancer. Notably, four out of eleven patients remained progression-free for over a year, with two patients undergoing definitive treatments showing significant responses. The study highlights the potential of this combination therapy to overcome tumor microenvironment challenges, enhancing CD8+ T-cell infiltration and improving patient outcomes. The company is optimistic about the ongoing randomized portion of the study.
Product Stage
growth-positive
Why Is Nano-Cap BioLineRx Stock Surging On Friday?
BioLineRx Ltd is advancing its CheMo4METPANC Phase 2 trial, which evaluates a combination therapy for pancreatic cancer. The trials pilot phase showed promising results, leading to an expansion of the study. The company plans to present new data at the 2025 American Society of Clinical Oncology Annual Meeting. BioLineRx recently completed a $10 million financing round, ensuring cash runway through the second half of 2026. Additionally, the company is reducing its operating expenses by over 70% starting January 2025, due to the transfer of the APHEXDA program to Ayrmid and the shutdown of its U.S. commercial operations. The trial is expected to be fully enrolled by 2027.
Product StageInvestmentLayoffs
growth-negative
BLRX: First Quarter Results
BioLineRx Ltd. reported its first quarter 2025 results, highlighting a shift in focus towards replenishing its pipeline and advancing clinical trials. The company generated $255,000 in license revenues, with a net income of $5.1 million, influenced by warrant revaluation. The transition of commercialization responsibilities for Aphexda to Gamida Cell has led to reduced R&D and marketing expenses. BioLineRx is actively seeking early-stage assets for acquisition, aiming for a faster approval pathway. The partnership with Columbia University is progressing, with a study in pancreatic ductal adenocarcinoma showing promising results. The company plans to expand trial sites and expects an interim readout in 2026. Despite these developments, the financial results indicate a challenging period with reduced revenues and a net loss when excluding non-operating income.
Product StagePartnersAcquisitionLayoffs
growth-negative
BioLine Rx Ltd (BLRX) Q1 2025 Earnings Call Highlights: Transformational Moves and Financial ...
BioLine Rx Ltd has reported a significant decrease in total revenue for Q1 2025 compared to the same period in 2024. Despite a strong financial position with $26.4 million in cash, the company has reduced its operating cash burden by over 70% and shut down its US operations, leading to layoffs in Israel. BioLine Rx has entered an exclusive outlicensing agreement with Aid Pharma Limited, which includes commercial milestones and royalties. The company is focusing on developing its drug, metxafortide, for pancreatic cancer, with promising early trial results. However, there are uncertainties regarding regulatory approval and the commercial success of the outlicensed product, Effexa.
PartnersLayoffs
growth-positive
BioLineRx Reports First Quarter 2025 Financial Results and Provides Corporate Update
BioLineRx Ltd., a biopharmaceutical company, reported its financial results for Q1 2025 and provided a corporate update. The company is focused on oncology and rare diseases, with ongoing evaluations for potential in-licensing and development. BioLineRx has out-licensed its FDA-approved stem cell mobilization agent, APHEXDA, to Ayrmid Ltd., which is performing well under Ayrmids stewardship. The company completed a $10 million financing round in January 2025 and has reduced its operating expenses significantly. BioLineRx is involved in the CheMo4METPANC Phase 2b clinical trial for motixafortide in pancreatic cancer, with support from Columbia University and Regeneron. The trial is expected to complete enrollment by 2027, with interim analysis planned. The company has a cash runway through the second half of 2026.
Product StageInvestmentPartnersCustomers
growth-positive
/PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare...
BioLineRx Ltd., a biopharmaceutical company, reported its financial results for Q1 2025 and provided updates on its ongoing projects. The company is focused on oncology and rare diseases, with its FDA-approved product, APHEXDA, performing well under Ayrmid Ltd.s stewardship. BioLineRx raised $10 million in January 2025 and reduced operating expenses by over 70% following the transfer of APHEXDA to Ayrmid. The company is actively evaluating new assets and expects to announce a significant transaction within the year. Clinical trials for motixafortide in pancreatic cancer and sickle cell disease are progressing, with new data to be presented at the 2025 ASCO Annual Meeting.
Product StagePartnersInvestmentCustomers
growth-positive
BioLineRx to Report First Quarter 2025 Results on May 27, 2025
BioLineRx Ltd., a biopharmaceutical company focused on oncology and rare diseases, announced it will release its unaudited financial results for Q1 2025 on May 27, 2025. The company will host a conference call featuring CEO Philip Serlin to discuss the results. BioLineRxs first approved product, APHEXDA® (motixafortide), is used for stem cell mobilization in multiple myeloma and is being commercialized by Ayrmid Ltd. and Gloria Biosciences. The company is leveraging its expertise in development, regulatory affairs, manufacturing, and commercialization to advance its pipeline and bring innovative therapies from the lab to patients.
growth-negative
BLRX: 2024 Financial Results
BioLineRx Ltd. reported its full-year 2024 financial results, showing revenues of $28.9 million and a net loss of $9.2 million. The company is transitioning the commercialization of Aphexda to Gamida Cell and is focusing on acquiring early-stage assets in oncology and rare diseases. The financial results include significant payments from Gloria Biosciences and Ayrmid. Despite a decrease in research and development expenses, the company experienced a net loss, partly due to non-operating expenses and financial costs. The announcement was made on March 31, 2025, with further details provided in a conference call and Form 20-F filing.
CustomersAcquisition
growth-positive
BioLine Rx Ltd (BLRX) Q4 2024 Earnings Call Highlights: Strategic Licensing and Market ...
BioLine Rx Ltd has executed a significant licensing agreement with AirMed Limited, which includes a $10 million upfront payment and potential commercial milestones of $87 million. Additionally, the company received a $9 million equity investment from High Bridge Capital, enhancing its financial position. The company plans to focus on drug development in oncology and rare diseases, leveraging its expertise in complex drug development. Despite shutting down its US commercial operations, BioLine Rx Ltd achieved a 10% market share milestone for its stem cell mobilization agent, Effexta, in the US market. The company faces uncertainties in revenue generation timing from its licensing agreements, particularly in Asia, and potential delays in clinical trial enrollments.
PartnersInvestmentLayoffs
growth-positive
BioLineRx Reports 2024 Financial Results and Provides Corporate Update
BioLineRx Ltd., a biopharmaceutical company focused on oncology and rare diseases, has reported significant progress in its strategic initiatives. The company executed a licensing agreement with Ayrmid Pharma Ltd. for APHEXDA® (motixafortide), securing a $10 million upfront payment and potential future milestones. Additionally, BioLineRx raised $19 million through financings, extending its cash runway through the second half of 2026. The company has implemented cost efficiencies, including shutting down U.S. commercial operations, reducing operating expenses by 70%. BioLineRx plans to in-license additional assets to advance through clinical proof-of-concept, leveraging its expertise in drug development. The company is optimistic about creating sustained value for shareholders.
PartnersInvestmentManagement Changes
growth-positive
BioLineRx to Report 2024 Annual Results on March 31, 2025
BioLineRx Ltd., a clinical-stage biopharmaceutical company, announced it will release its audited financial results for the year ended December 31, 2024, on March 31, 2025. The company, which focuses on therapies in oncology and rare diseases, will host a conference call featuring remarks by CEO Philip Serlin. BioLineRxs first approved product, APHEXDA® (motixafortide), is used for stem cell mobilization in multiple myeloma and is being developed and commercialized by Ayrmid Ltd. and Gloria Biosciences. The company is leveraging its expertise in development, regulatory affairs, manufacturing, and commercialization to advance its pipeline.
Product StagePartners
growth-positive
/PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare...
BioLineRx Ltd., a clinical-stage biopharmaceutical company, announced it will release its audited financial results for the year ending December 31, 2024, on March 31, 2025. The company will host a conference call featuring remarks by CEO Philip Serlin. BioLineRx focuses on developing therapies for oncology and rare diseases, with its first approved product, APHEXDA® (motixafortide), used for stem cell mobilization in multiple myeloma. The product is commercialized by Ayrmid Ltd. globally (excluding Asia) and Gloria Biosciences in Asia. The company leverages its expertise in development, regulatory affairs, manufacturing, and commercialization to advance its pipeline.
Product StagePartners
growth-positive
BLRX: Aphexda Transition Progressing
BioLineRx Ltd. is transitioning its commercialization activities for Aphexda to Ayrmid’s subsidiary, Gamida Cell. This strategic move aligns with Gamida Cells existing commercialization of Omisirge, creating synergies in the treatment of blood cancers. Ayrmid and Gloria Biosciences are key partners, with Ayrmid handling non-Asian territories and Gloria focusing on Asia. Both partners have committed to upfront payments, milestones, and royalties. BioLineRx, with FDA approval for Aphexda, is now focusing on acquiring new preclinical and clinical assets in oncology or rare diseases. The company has secured sufficient funding to support its activities until the second half of 2026. Additionally, BioLineRx announced a change in the ADS to ordinary shares ratio, effective January 30, 2025.
PartnersFDA approvedInvestment
growth-positive
/PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare...
BioLineRx Ltd., a clinical-stage biopharmaceutical company, has announced strategic partnerships and financial plans to enhance its growth. The company has signed exclusive license agreements with Ayrmid Ltd. and Guangzhou Gloria Biosciences Co., Ltd., providing significant upfront capital and potential milestone payments. BioLineRx has received FDA approval for its product APHEXDA® (motixafortide) and is focusing on expanding its pipeline with new assets in oncology and rare diseases. The company has strengthened its balance sheet with recent equity investments and plans to maintain its Nasdaq listing through a reverse stock split. BioLineRx aims to leverage its partnerships to create additional value for shareholders.
Product StagePartnersInvestmentFDA approved/pending approval
growth-positive
BioLineRx Issues Letter to Shareholders
BioLineRx Ltd., a clinical-stage biopharmaceutical company, has outlined its strategic vision following a major strategy shift. The company has signed exclusive license agreements with Ayrmid Ltd. and Guangzhou Gloria Biosciences Co., Ltd. to commercialize its FDA-approved stem cell mobilization agent, APHEXDA (motixafortide). These agreements provide BioLineRx with significant non-dilutive upfront capital and potential future royalties. Ayrmid will develop and commercialize APHEXDA outside Asia, excluding solid tumors, with an upfront payment of $10 million and potential milestones up to $87 million. GloriaBio will focus on Asia, starting with stem cell mobilization, with an upfront payment of $15 million and potential milestones up to $250 million. Equity investments totaling $23.6 million were also made.
Product StagePartnersInvestment
growth-positive
BioLineRx Announces Change to Ratio of American Depositary Shares to Ordinary Shares
BioLineRx Ltd., a clinical-stage biopharmaceutical company, announced a change in the number of ordinary shares represented by its American Depositary Shares (ADS), effectively implementing a 1-for-40 reverse stock split. This adjustment aims to enhance the trading suitability of the ADSs on the Nasdaq Capital Market and ensure compliance with Nasdaqs listing standards. The company is well-capitalized with $29.5 million in cash, providing a financial runway through the second half of 2026. BioLineRx is focused on developing motixafortide for pancreatic cancer and expanding its pipeline. The company emphasizes the importance of maintaining its Nasdaq listing for executing its long-term strategy.
Public Trading
growth-positive
/PRNewswire/ -- BioLineRx Ltd. (Nasdaq: BLRX) (TASE: BLRX) ("BioLineRx" or the "Company"), a development stage biopharmaceutical company pursuing life-changing...
BioLineRx Ltd., a biopharmaceutical company focused on oncology and rare diseases, announced a registered direct offering of 50,000,000 American Depositary Shares (ADSs) and accompanying warrants, expected to raise approximately $10 million. The offering, managed by H.C. Wainwright & Co., is set to close around January 7, 2025. The funds will be used for research and development, pipeline expansion, and general corporate purposes. BioLineRxs first approved product, APHEXDA, is being developed and commercialized by Ayrmid Ltd. and Gloria Biosciences. The company is leveraging its expertise to advance its pipeline and ensure its discoveries reach patients.
PIPE/PO
growth-positive
BioLineRx Announces $10 Million Registered Direct Offering
BioLineRx Ltd., a development stage biopharmaceutical company, announced a registered direct offering of 50,000,000 American Depositary Shares (ADSs) and accompanying warrants, priced at $0.20 per ADS. The offering is expected to close around January 7, 2025, with gross proceeds estimated at $10 million. H.C. Wainwright & Co. is acting as the exclusive placement agent. The funds will be used for research and development, pipeline expansion, and general corporate purposes. This move is seen as growth-positive, aiding BioLineRx in advancing its oncology and rare disease therapies.
PIPE/POInvestment
growth-positive
BLRX: Ayrmid Assumes Commercialization Efforts
BioLineRx Ltd. announced a commercialization agreement with Ayrmid Ltd. and its subsidiary Gamida Cell Ltd., granting Ayrmid rights to commercialize Aphexda across all indications except in solid tumors and in all territories except Asia. This agreement includes a $10 million upfront payment, royalties, and potential commercial milestones of $87 million. Following this, BioLineRxs expenses are expected to decline significantly as it focuses on research and development. The company reported third-quarter revenues of $4.9 million and a net loss of $5.8 million, with Aphexda revenues contributing $1.7 million. The company also launched a digital resource for multiple myeloma patients and received a new patent allowance. The announcement was made on November 25, 2024.
Partners
growth-positive
BioLine Rx Ltd (BLRX) Q3 2024 Earnings Call Highlights: Revenue Surge and Strategic Shifts
BioLine Rx Ltd reported a significant improvement in its financial performance for Q3 2024, with total revenue of $4.9 million compared to no revenue in Q3 2023. The company executed a major licensing agreement with Ayrmid Ltd., securing a $10 million upfront payment and potential commercial milestones of $87 million. Additionally, BioLine Rx received a $9 million equity investment from Highbridge Capital, which will aid in debt repayment and restructuring. The company plans to focus on drug development, particularly in oncology and rare diseases, and has achieved a 10% market share for its stem cell mobilization agent, APHEXDA, in the US. However, BioLine Rx is shutting down its US commercial operations, which may lead to transitional challenges. The company faces uncertainties in the development of motixafortide for pancreatic cancer and is reliant on partnerships for its PDAC program.
PartnersInvestmentLayoffs
growth-positive
BioLineRx Reports Third Quarter 2024 Financial Results and Provides Update on Transformation to Drive Shareholder Value
BioLineRx Ltd. has executed a license agreement with Ayrmid Ltd. for the commercialization of APHEXDA® (motixafortide), receiving a $10 million upfront payment, up to $87 million in commercial milestones, and 18-23% tiered royalties on sales. Additionally, BioLineRx secured a $9 million equity investment from Highbridge Capital Management, LLC. The company has also restructured its long-term debt by approximately $16.5 million and expects to reduce operational expenses by over 70% following the out-licensing of the APHEXDA commercial program. BioLineRx plans to focus on developing therapies in rare diseases and oncology, leveraging its new financial foundation supported by sales royalties and milestone payments.
PartnersInvestment
growth-positive
BioLineRx, Ayrmid enter license agreement for motixafortide through Gamida Cell
BioLineRx has entered into a license agreement with Ayrmid, the parent company of Gamida Cell, for its FDA-approved stem cell mobilization agent, motixafortide. Ayrmid will develop and commercialize Aphexda, excluding solid tumor indications and territories outside Asia. BioLineRx will receive a $10 million upfront payment and is eligible for up to $87 million in commercial milestones, plus royalties. Additionally, BioLineRx secured a $9 million equity investment from Highbridge Capital Management. This agreement and investment are expected to reduce BioLineRxs long-term debt and operational expenses, while providing a foundation to advance its pipeline. The equity investment is set to close on November 21. BioLineRx will continue developing motixafortide for pancreatic ductal adenocarcinoma through collaborations with Columbia University and Gloria Biosciences.
PartnersInvestment
growth-positive
BioLineRx and Ayrmid Ltd. Enter into Exclusive License Agreement to Commercialize APHEXDA® (motixafortide) through Gamida Cell Ltd.
BioLineRx has entered into a licensing agreement with Ayrmid Ltd., the parent company of Gamida Cell, for its FDA-approved stem cell mobilization agent, APHEXDA. Under the agreement, BioLineRx will receive a $10 million upfront payment and is eligible for up to $87 million in commercial milestones, along with royalties on net sales. This deal allows BioLineRx to retain rights for solid tumor indications and focus on oncology and rare diseases. Additionally, BioLineRx received a $9 million equity investment from Highbridge Capital Management to support its pipeline and expansion. The transaction will help reduce BioLineRxs operational expenses and debt, enabling a more focused development strategy. The agreement was announced on November 20, 2024.
InvestmentPartners
growth-positive
BioLineRx to Report Third Quarter 2024 Results on November 25, 2024
BioLineRx Ltd., a commercial stage biopharmaceutical company, announced it will release its unaudited financial results for the third quarter ended September 30, 2024, on November 25, 2024. The company will host a conference call at 8:30 a.m. EST, featuring remarks by CEO Philip Serlin. BioLineRx is focused on developing therapies in oncology and rare diseases, with its first approved product, APHEXDA® (motixafortide), indicated for stem cell mobilization in multiple myeloma. The company is advancing a pipeline of investigational medicines for conditions like sickle cell disease and pancreatic cancer. Headquartered in Israel, BioLineRx operates in the U.S. and is committed to moving innovative therapeutics from development to commercialization.
growth-positive
/PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare...
BioLineRx Ltd., a commercial stage biopharmaceutical company, announced it will release its unaudited financial results for the third quarter ended September 30, 2024, on November 25, 2024. The company will host a conference call at 8:30 a.m. EST, featuring remarks by CEO Philip Serlin. BioLineRx focuses on developing therapies in oncology and rare diseases, with its first approved product, APHEXDA® (motixafortide), used for stem cell mobilization in multiple myeloma. The company is advancing a pipeline of investigational medicines for conditions like sickle cell disease and pancreatic cancer. Headquartered in Israel, BioLineRx operates in the U.S. and is committed to moving innovative therapeutics from development to commercialization.
growth-positive
BioLineRx Announces Oral Presentation on Data from Phase 1 Clinical Trial Evaluating Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease at ASH 2024
BioLineRx Ltd., a biopharmaceutical company, announced promising initial results from a Phase 1 clinical trial evaluating motixafortide, both as a monotherapy and in combination with natalizumab, for hematopoietic stem cell mobilization in gene therapies for sickle cell disease. The study, conducted in collaboration with Washington University School of Medicine, suggests that motixafortide could enable the collection of necessary stem cells in a single apheresis cycle, potentially improving the treatment process for patients. These findings will be presented at the American Society of Hematology Annual Meeting in December 2024. The positive results indicate a potential advancement in gene therapy access for sickle cell patients, marking a growth-positive impact for BioLineRx.
Partners
growth-positive
BioLineRx Announces USPTO Allowance of New Composition of Matter Patent on Motixafortide
BioLineRx Ltd., a biopharmaceutical company, has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent covering the composition of motixafortide, extending its patent protection in the U.S. through December 2041. This strengthens BioLineRxs intellectual property estate and reflects the USPTOs recognition of motixafortides unique attributes. The drug, marketed as APHEXDA, has been approved by the FDA for use in multiple myeloma patients undergoing autologous stem cell transplantation and has been granted Orphan Drug Designation for pancreatic cancer and acute myeloid leukemia. The patent extension and exclusivity are expected to enhance the companys market position and support its ongoing commercialization efforts.
growth-positive
/PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare...
BioLineRx Ltd., a biopharmaceutical company, has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent covering the composition of motixafortide (APHEXDA®/BL-8040). This patent extends the companys intellectual property protection in the U.S. through December 2041. Motixafortide is used for stem cell mobilization in multiple myeloma patients and is being investigated for other conditions like pancreatic cancer and sickle cell disease. The drug has been granted Orphan Drug Designation in the U.S. and Europe for various treatments. The patent extension is expected to bolster BioLineRxs market position and enhance its commercial prospects.
growth-positive
/PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare...
BioLineRx Ltd. has launched Mobilization Matters, a digital resource aimed at supporting multiple myeloma patients preparing for stem cell collection. This initiative, launched on Apheresis Awareness Day, includes patient stories and educational resources. In partnership with the HealthTree Foundation, BioLineRx is conducting the Mobilization Matters Stem Cell Collection Survey to gather patient insights on their experiences with stem cell collection and apheresis. The survey aims to enhance understanding and improve care strategies, with results expected in Q1 2025. This marks the first patient experience study by the HealthTree Foundation on this topic.
Partners
growth-positive
BioLineRx Launches 'Mobilization Matters': A Digital Resource for People with Multiple Myeloma Preparing for Stem Cell Collection
BioLineRx Ltd., a commercial stage biopharmaceutical company, has launched Mobilization Matters, a digital resource aimed at supporting multiple myeloma patients preparing for stem cell collection for autologous stem cell transplants. This initiative, launched in partnership with the HealthTree Foundation, includes patient stories, educational resources, and a survey to gather insights on patient experiences. The survey results are expected in Q1 2025 and aim to improve patient care and support strategies. The collaboration underscores BioLineRxs commitment to enhancing patient education and fostering dialogue between patients and healthcare teams.
Partners
growth-positive
BLRX: On Track for 60% Formulary Placement
BioLineRx Ltd. reported a near doubling of its motixafortide product sales in 2Q:24, with sales reaching $1.8 million. The company also announced a clinical trial agreement with St. Jude’s to evaluate motixafortide in a second gene therapy study for sickle cell disease. Gloria Biosciences’ IND application for stem cell mobilization was cleared in China with a pivotal trial slated for 2H:24. The companys second quarter in 2024 achieved sales of $5.4 million and net income of $484,000. BioLineRx expects to have sufficient resources to meet capital requirements into 2025.
CustomersPartnersManagement Changes
growth-positive
BioLineRx Reports Second Quarter 2024 Financial Results and Recent Corporate and Portfolio Updates
BioLineRx Ltd., a biopharmaceutical company, has reported its financial results for Q2 2024. The company has secured APHEXDA formulary placement among the top 80 transplant centers, representing around 37% of stem cell transplant procedures performed. This surpasses the companys stated goal for the quarter and is on track to reach around 60% by the end of Q4. The company has also doubled the number of centers ordering APHEXDA during Q2. BioLineRx has entered into a clinical trial agreement with St. Jude Childrens Research Hospital to evaluate motixafortide for hematopoietic stem cell mobilization for gene therapies in sickle cell disease.
CustomersPartnersExpand
Neutral
BioLineRx to Report Second Quarter 2024 Results on August 15, 2024
BioLineRx Ltd., a commercial stage biopharmaceutical company, announced that it will release its unaudited financial results for the second quarter ended June 30, 2024 on Thursday, August 15, 2024. The company will host a conference call featuring remarks by CEO Philip Serlin. The company is pursuing life-changing therapies in oncology and rare diseases, with its first approved product being APHEXDA® for stem cell mobilization for autologous transplantation in multiple myeloma.
None
growth-positive
BLRX: First Quarter 2024 Results
BioLineRx Ltd. reported a 390% sequential sales increase in its first full quarter of sales in 1Q:24. The companys partnerships are advancing with Gloria Biosciences and Columbia University, and a new sickle cell gene therapy trial was announced with St. Jude Children’s Research Hospital. BioLineRxs first quarter in 2024 achieved sales of $6.9 million and net loss of ($696,000). The company raised gross proceeds of $26 million in two transactions following the end of the first quarter including a $6 million registered direct offering and access of the second tranche of a $20 million in debt financing with BlackRock.
CustomersPartnersInvestment
growth-positive
Millionaire Makers: 7 Stocks You Can Buy for $2 That Can 10X by 2025
The article discusses seven stocks that are currently priced at $2 or less and have the potential to increase tenfold by 2025. These include Reliance Global, a business group that acquires and manages retail insurance agencies in the US; aTyr Pharma, a biotech company focused on the treatment of lung diseases; BioLineRx, a company commercializing therapeutics for the treatment of various cancers and rare diseases; Knightscope, a company that builds fully autonomous security robots; Adial Pharmaceuticals, a company working to address addiction disorders; Society Pass, a company building an ecosystem encompassing e-commerce and fintech in Southeast Asia; and Enviva, a company producing sustainable wood pellets as a low-carbon alternative to fossil fuels.
AcquisitionInvestment
growth-positive
BioLineRx Announces Clinical Trial Agreement with St. Jude Children's Research Hospital, Inc. to Evaluate Motixafortide for CD34+ Hematopoietic Stem Cell (HSC) Mobilization For Gene Therapy Applications in Sickle Cell Disease (SCD)
BioLineRx Ltd., a commercial stage biopharmaceutical company, has announced a multi-center Phase 1 clinical trial sponsored by St. Jude Childrens Research Hospital, Inc. to evaluate motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with sickle cell disease (SCD). The trial will be conducted in collaboration with researchers from St. Jude Childrens Research Hospital, Inc. and two other clinical sites. The trial aims to evaluate potential new mobilization options for patients with SCD. Enrollment in the study is expected to begin in the next few months.
PartnersExpand
growth-positive
BioLineRx Reports First Quarter 2024 Financial Results and Recent Corporate and Portfolio Updates
BioLineRx Ltd., a commercial stage biopharmaceutical company, reported its unaudited financial results for the first quarter ended March 31, 2024. The company saw steady growth in the adoption of its product APHEXDA in the first full quarter post-approval. It secured APHEXDA formulary placement at institutions representing ~26% of stem cell transplant procedures performed. The company also announced new data in an abstract accepted at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on the pilot phase of an ongoing Phase 2b pancreatic cancer clinical trial collaboration with Columbia University. The company completed debt and equity financing totaling $26 million to support U.S. commercialization of APHEXDA and advance lifecycle expansion activities.
CustomersPartnersInvestmentExpand
growth-positive
BioLineRx Announces Abstract on Pilot Study Data from Phase 2 Combination Clinical Trial Evaluating Motixafortide in First-Line Pancreatic Cancer (PDAC) at American Society of Clinical Oncology (ASCO) 2024 Annual Meeting
BioLineRx Ltd., a biopharmaceutical company, announced new data from the pilot phase of the CheMo4METPANC Phase 2 clinical trial. The trial is evaluating the companys CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard-of-care chemotherapies gemcitabine and nab-paclitaxel, in first-line pancreatic cancer. The results showed a significant increase in CD8+ T-cell density in tumors from all 11 patients treated. Based on these results, the trial was amended to become a randomized study, with planned enrollment increasing from 30 to 108 patients. The trial is sponsored by Columbia University.
PartnersExpand
Neutral
BioLineRx to Report First Quarter 2024 Results on May 28, 2024
BioLineRx Ltd., a commercial stage biopharmaceutical company, announced that it will release its unaudited financial results for the quarter ended March 31, 2024 on Tuesday, May 28, 2024, before the U.S. markets open. The company will host a conference call featuring remarks by Philip Serlin, Chief Executive Officer. The company is pursuing life-changing therapies in oncology and rare diseases.
growth-negative
BioLineRx Announces Receipt of Nasdaq Minimum Bid Price Notification
BioLineRx Ltd., a commercial stage biopharmaceutical company, has received a notification from the Nasdaq Stock Market LLC for not being in compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market. The companys American Depositary Shares (ADSs) were below USD $1.00 for 30 consecutive trading days. The company now has a grace period of 180 calendar days, until November 11, 2024, to regain compliance. If the company fails to regain compliance by the deadline, it may face delisting.
Public Trading
growth-positive
BioLineRx Announces Poster Presentation on Economic Model Data for APHEXDA® (motixafortide) as part of CD34+ Hematopoietic Stem Cell Mobilization in Patients with Multiple Myeloma at ISPOR 2024
BioLineRx Ltd., a commercial stage biopharmaceutical company, announced that new economic model data will be presented on APHEXDA (motixafortide) for CD34+ hematopoietic stem cell (HSC) mobilization in patients with multiple myeloma at the ISPOR 2024 conference. The new economic model assessed the cost and healthcare resource utilization impacts of multiple apheresis attempts. The data are expected to be published in Value in Health, Volume 27, Issue 6, S1 (June 2024).
CustomersPartners
growth-positive
BioLineRx Announces Poster Presentation on Apheresis Center Efficiency and CXCR4 Antagonists including APHEXDA® (motixafortide) in Patients with Multiple Myeloma at the ASFA 2024 Annual Meeting
BioLineRx Ltd., a commercial stage biopharmaceutical company, announced a poster presentation on apheresis center efficiency and CXCR4 antagonists including APHEXDA (motixafortide) in patients with multiple myeloma. The poster will be presented at the American Society for Apheresis (ASFA) 2024 Annual Meeting. The model in the poster analyzed the number of apheresis days needed to collect ≥6 million CD34+ cells/kg using different mobilization regimens based on product-specific Phase 3 studies. The study showed that APHEXDA combined with filgrastim (G-CSF) significantly enhanced the rate of mobilizing ≥6 × 106 CD34+ cells/kg in up to 2 apheresis days compared to placebo + filgrastim.
CustomersExpand
growth-positive
BioLineRx Accesses Second Tranche of $20 Million Under Previously Announced $40 Million Non-Dilutive Debt Financing Agreement
BioLineRx Ltd., a biopharmaceutical company, has drawn down the second tranche of $20 million from its $40 million non-dilutive debt financing agreement with BlackRock. The funds will be used to accelerate the uptake of APHEXDA in stem cell mobilization, expansion activities in sickle cell disease, and the motixafortide metastatic pancreatic cancer program. The agreement was initially announced in September 2022. The remaining tranche of $10 million may be available for drawdown through October 1, 2024.
InvestmentExpand
growth-positive
BioLineRx Announces $6 Million Registered Direct Offering
BioLineRx Ltd., a commercial stage biopharmaceutical company, has announced that it has entered into definitive agreements with several institutional investors for the issuance and sale in a registered direct offering of 7,500,000 of the Companys American Depositary Shares (ADSs) and warrants to purchase up to an aggregate of 7,500,000 ADSs. The gross proceeds from the offering are expected to be $6.0 million. BioLineRx intends to use the net proceeds from the offering to support the commercialization of APHEXDA® (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in patients with multiple myeloma, advance its pancreatic cancer clinical development program and other pipeline programs, and for general corporate purposes.
InvestmentExpand
growth-positive
BLRX: First Aphexda Sales Recognized
BioLineRx Ltd. has been focusing on the commercialization of Aphexda following its approval in September 2023. Two other trials evaluating motixafortide have begun, one in collaboration with the Washington University School of Medicine for stem cell mobilization in sickle cell disease, and the other with Columbia University for first line pancreatic ductal adenocarcinoma. The company reported full year 2023 financial results, with revenues of $4.8 million, largely from an upfront payment of $4.6 million related to the Gloria license agreement. The company also announced the termination of the AGI-134 program.
CustomersPartnersManagement Changes
growth-positive
BioLineRx Ltd. (NASDAQ:BLRX) Q4 2023 Earnings Call Transcript
BioLineRx Ltd. held its Q4 2023 earnings call on March 26, 2024. The company discussed the launch of its product, APHEXDA, for stem cell mobilization, which has been well received by payers and top tier stem cell transplant centers. BioLineRx also highlighted its partnership with Gloria Biosciences for the development and commercialization of motixafortide across all indications in Asia. The company reported total revenues of $4.8 million for the year ended December 31, 2023, compared to no revenues for the year ended December 31, 2022. BioLineRx anticipates that its current funds will be sufficient to support operations into 2025.
CustomersPartnersManagement ChangesExpand
growth-positive
BioLineRx Reports 2023 Financial Results and Recent Corporate and Portfolio Updates
BioLineRx Ltd., a biopharmaceutical company, has reported its financial results for the year ended December 31, 2023. The company has made significant progress with APHEXDA, securing payer coverage representing about 95% of covered lives in the U.S. The first patient has been dosed in a randomized Phase 2b clinical trial evaluating motixafortide in first-line pancreatic cancer. BioLineRx is also supporting partner Gloria Biosciences in plans to execute a pivotal bridging study of motixafortide in stem cell mobilization and a Phase 2b randomized study in first-line pancreatic cancer in China. The companys total revenues for 2023 were $4.8 million.
CustomersPartnersInvestmentExpand
growth-positive
BioLineRx to Report 2023 Annual Financial Results on March 26, 2024
BioLineRx Ltd., a commercial stage biopharmaceutical company, announced it will release its audited financial results for the year ended December 31, 2023 on Tuesday, March 26, 2024. The company will host a conference call featuring remarks by CEO Philip Serlin. BioLineRx is pursuing life-changing therapies in oncology and rare diseases, with its first approved product being APHEXDA® for stem cell mobilization for autologous transplantation in multiple myeloma.
Management Changes
growth-positive
BioLineRx Strengthens Intellectual Property Estate with Notice of Allowance for U.S. Patent Covering Method of Manufacturing Motixafortide (BL-8040) Suitable for Large Scale Production
BioLineRx Ltd., a biopharmaceutical company, has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent covering a method of manufacturing motixafortide (BL-8040) that is suitable for large scale production. This adds to the companys existing patents covering various aspects of motixafortide. The company was also granted seven years of Orphan Drug market exclusivity beginning on September 8, 2023, the day APHEXDA® (motixafortide) was approved by the FDA. The company plans to scale up the production of motixafortide to support the commercial demand for APHEXDA for stem cell mobilization in multiple myeloma patients.
CustomersPartners
growth-positive
BioLineRx Announces First Patient Dosed in Randomized Phase 2 Combination Clinical Trial Evaluating Motixafortide in First-Line Pancreatic Cancer (PDAC)
BioLineRx Ltd., a commercial stage biopharmaceutical company, has announced the dosing of the first patient in the CheMo4METPANC Phase 2 clinical trial. The trial, conducted in collaboration with Columbia University, is evaluating the companys CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer. The trial is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies.
InvestmentPartners
growth-positive
BLRX: Poster Presentations
BioLineRx presented two posters at the Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR). The presentations focused on the Genesis trial data and the use of motixafortide in multiple myeloma patients and healthy volunteers requiring an autologous stem cell transplant. The research found that motixafortide was effective in producing a high proportion of stem cells, especially in patients with risk factors that may limit collection. BioLineRx is now commercializing motixafortide, branded as Aphexda, in the United States.
InvestmentExpand
growth-positive
3 Top Penny Stocks for 5,000% Upside in 2024 and Beyond
The article discusses three penny stocks that could potentially offer significant upside in the future. These include BioLine, a drug development company with a market capitalization of $96 million and a potential upside of 1,594% according to H.C. Wainwright. Tonix Pharma, a pharmaceutical company focused on repurposed drugs for central nervous system conditions, has a potential upside of 1,800% according to Alliance Global Partners. Kezar Life Sciences, a company developing novel protein-targeting approaches, has a potential upside of 2,253% according to H.C. Wainwright.
Investment
growth-positive
BioLineRx Announces Acceptance of Two Poster Presentations on APHEXDA® (motixafortide) for CD34+ Hematopoietic Stem Cell (HSC) Mobilization in Patients with Multiple Myeloma at the 2024 Tandem Meetings of ASTCT® and CIBMTR®
BioLineRx Ltd., a commercial stage biopharmaceutical company, has announced that new post-hoc subgroup analyses and pharmacodynamic data will be presented on APHEXDA (motixafortide) for CD34+ hematopoietic stem cell (HSC) mobilization in patients with multiple myeloma at the 2024 Tandem Meetings. The data includes pharmacokinetics and pharmacodynamics data as well as post-hoc subgroup analyses from the Phase 3 GENESIS trial. The trial is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of APHEXDA plus filgrastim, compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients.
CustomersExpand
growth-positive
BioLineRx Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease
BioLineRx Ltd., a biopharmaceutical company, has announced the dosing of the first patient in a Phase 1 clinical trial. The trial is evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD). The trial, conducted in collaboration with Washington University School of Medicine in St. Louis, aims to enroll five patients diagnosed with SCD. It will assess the safety and tolerability of the two regimens. Initial data from this study is expected in the second half of 2024.
Partners
growth-positive
BioLineRx Ltd. (NASDAQ:BLRX) Q3 2023 Earnings Call Transcript
BioLineRx Ltd. reported its Q3 2023 earnings and discussed the progress of its Stem Cell Mobilization program. The company announced the FDA approval of Motixafortide, known commercially as APHEXDA, for use in patients with multiple myeloma. The company has built out its U.S. commercial infrastructure and has received positive feedback from top-tier transplant centers across the U.S. BioLineRx also closed an exclusive license agreement with Gloria Biosciences for the development and commercialization of Motixafortide in Asia. The companys CFO reported sales and marketing expenses of $8.1 million for Q3 2023, an increase of 517.4% compared to the same period last year.
CustomersPartnersInvestmentExpand
growth-positive
BLRX: A Series of Fortunate Events
BioLineRx Ltd. reported its third quarter results, highlighting the FDA approval of Aphexda and the closing of the Asia deal with Gloria Biosciences. The company also announced early success with the Aphexda launch in US markets. The National Comprehensive Cancer Network (NCCN) has included Aphexda as part of the guidelines for hematopoietic cell transplantation. The company also reported a net loss of $16.0 million and a cash burn of $9.9 million. However, the companys deal with Gloria Biosciences has contributed to cash balances in the amount of almost $30 million, which is expected to fund operations into 2025.
CustomersPartnersInvestmentExpand
growth-positive
BioLineRx Reports Third Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates
BioLineRx Ltd., a commercial stage biopharmaceutical company, has reported its unaudited financial results for Q3 2023 and provided corporate and portfolio updates. The company received FDA approval for APHEXDA® (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma. It also closed an exclusive license agreement for motixafortide in the Asia region with a concurrent strategic equity investment. The company began enrollment of a Phase 1 trial evaluating motixafortide for CD34+ hematopoietic stem cell mobilization for gene therapies in sickle cell disease.
InvestmentPartnersManagement Changes
Neutral
BioLineRx to Report Third Quarter 2023 Results on November 20, 2023
BioLineRx Ltd., a commercial stage biopharmaceutical company, has announced that it will release its unaudited financial results for the quarter ended September 30, 2023, on Monday, November 20, 2023, before the U.S. markets open. The company will host a conference call featuring remarks by Philip Serlin, Chief Executive Officer. The company is pursuing life-changing therapies in oncology and rare diseases.
growth-positive
3 Tech Stocks That Wall Street Loves More Than Nvidia
The article discusses the promising future of three tech companies: Zoom Video Communications, BioLine RX, and Broadcom. Zoom, a video conferencing service, has seen a year-to-date decline of 10.02% but is expected to grow due to its Zoom AI Companion feature. BioLine RX, a therapeutics company, is expected to grow due to the recent FDA approval of their flagship drug, APHEXDA. Broadcom, a semiconductor company, has outperformed competitors and is expected to perform well due to the projected increase in the global semiconductor industry.
CustomersInvestment
growth-positive
BioLineRx entered Exclusive License Agreement to Motixafortide in Asia, advisored by M.S.Q. Ventures
BioLineRx Ltd. has entered into an exclusive license agreement with Guangzhou Gloria Biosciences Co., Ltd. and an associated investor for the development of motixafortide across all indications in Asia. The agreement includes a $15 million upfront payment and an equity investment of $14.6 million, with potential for up to $50 million in development and regulatory milestones, and up to $200 million in potential commercial milestones. The partnership will leverage GloriaBios expertise in the development and commercialization of cancer immunotherapies in China.
PartnersInvestment
Growth-Positive
3 Top Penny Stocks to Make You a Millionaire in 5 Years
The article discusses the potential of three companies, Solid Power, CarParts.com, and BioLine RX, as long-term investments in the penny stock market. Solid Power, a company developing solid-state batteries, is expected to make significant contributions to the EV industry. CarParts.com, a provider of car parts in the U.S. and Philippines, is expected to benefit from the trend of consumers keeping their vehicles for longer. BioLine RX, an Israeli biotech firm with U.S. operations, has multiple FDA-approved treatments in its pipeline and more potentially on the way.
Investment
growth-positive
BioLineRx Announces Closing of Exclusive License Agreement to Motixafortide in Asia and Concurrent Strategic Equity Investment
BioLineRx Ltd has closed an exclusive license agreement with Guangzhou Gloria Biosciences Co., Ltd for the development of motixafortide across all indications in Asia. The agreement includes a $15 million upfront payment, up to $50 million in potential development and regulatory milestones, and up to $200 million in potential commercial milestones. Gloria Biosciences will be responsible for the development and commercialization of motixafortide in Asia. The transaction also included an equity investment of $14.6 million in BioLineRx.
PartnersInvestment
growth-positive
BioLineRx Announces Encouraging Data from Pilot Phase of Phase 2 Combination Clinical Trial with Motixafortide in First-Line Pancreatic Cancer (PDAC)
BioLineRx Ltd. has announced encouraging data from the pilot phase of the CheMo4METPANC Phase 2 clinical trial evaluating the companys CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, in first-line pancreatic cancer. The data were presented at the American Association of Cancer Research Special Conference on Pancreatic Cancer. The pilot phase enrolled 11 patients with metastatic pancreatic cancer, 6 of whom experienced a partial response. The company is now enrolling for a multi-center, randomized Phase 2 study.
InvestmentExpand
growth-positive
BioLineRx Announces Acceptance of Oral Presentation on Pilot Phase Data from Phase 2 Combination Clinical Trial with Motixafortide in First-Line PDAC at AACR Special Conference on Pancreatic Cancer
BioLineRx Ltd., a commercial stage biopharmaceutical company, has announced that pilot phase data from a Phase 2 clinical trial with motixafortide in first-line pancreatic ductal adenocarcinoma (PDAC) will be presented at the American Association for Cancer Research (AACR) Special Conference on Pancreatic Cancer in September 2023. The trial, sponsored by Columbia University, is designed to evaluate the companys CXCR4 inhibitor motixafortide in combination with PD-1 inhibitor cemiplimab and standard of care chemotherapies gemcitabine and nab-paclitaxel. The trial was amended to become a randomized study, with planned enrollment increasing from 30 to 102 patients.
InvestmentExpand
growth-positive
BLRX: …Go!
BioLineRx Ltd. announced FDA approval of Aphexda, its stem cell mobilization product for autologous transplantation in multiple myeloma. The company has prepared for commercialization of Aphexda and has assets in place to build relationships with payors and providers. The commercialization team is in discussions with payors for coverage and reimbursement and BioLineRx is engaging leading physicians in the specialty to educate the community. The company has also signed an exclusive license agreement to develop and commercialize motixafortide in Asia along with an equity investment from two partners.
CustomersPartnersInvestment
growth-positive
BioLineRx stem cell drug for myeloma patients wins FDA nod
BioLineRx Ltd., an Israeli biopharmaceutical company, has received approval from the US Food and Drug Administration for its product APHEXDA. The product, used in combination with filgrastim, helps mobilize hematopoietic stem cells for collection and transplantation in patients with multiple myeloma. The companys CEO, Philip Serlin, stated that the product would be ready for marketing in a few weeks. BioLineRx has also signed an agreement to market the product in the Asian market. The companys share price has risen 320% over the past six months, and it had $32.8 million in cash as of the end of June 2023.
CustomersPartnersInvestment
growth-positive
BioLineRx Announces FDA Approval of APHEXDA™ (motixafortide) in Combination with Filgrastim (G-CSF) to Mobilize Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
BioLineRx Ltd., a biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has approved APHEXDA™ (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. This is the first innovation in stem cell mobilization for multiple myeloma to be approved in the U.S. in a decade. The FDA approval of APHEXDA is based on results from the 2-part, Phase 3 GENESIS trial. BioLineRx expects to make APHEXDA available later this month.
CustomersManagement Changes
growth-positive
BLRX: On Your Marks, Get Set…
BioLineRx Ltd. has announced its Q2 2023 operational and financial results, revealing an exclusive agreement for development and commercialization in Asia, which includes an upfront payment and investment that will extend the company’s cash runway. The company has also begun a Phase II metastatic pancreatic cancer trial. BioLineRx is preparing for the anticipated FDA approval of motixafortide for stem cell mobilization in multiple myeloma patients. The companys financial results showed a decrease in research and development expenses and an increase in sales and marketing expenses due to the initiation of pre-commercialization activities related to motixafortide.
PartnersInvestmentExpand
growth-positive
BioLineRx Ltd. (NASDAQ:BLRX) Q2 2023 Earnings Call Transcript
BioLineRx Ltd. held its Q2 2023 earnings call, discussing its financial results and future plans. The company is preparing for the potential U.S. approval of its first therapy in stem cell mobilization and is ready for commercial launch. BioLineRx has also strengthened its balance sheet through a strategic relationship with Gloria Biosciences and Hang Seng Technology, which includes a $15 million upfront payment and up to $250 million based on the achievement of specific development, regulatory, and commercial milestones. The company is also advancing its pancreatic development program and positioning Motixafortide for development in Asia.
InvestmentPartners
growth-positive
BioLineRx Reports Second Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates
BioLineRx Ltd., a pre-commercial stage biopharmaceutical company, has reported its unaudited financial results for Q2 2023 and provided corporate and portfolio updates. The company has signed an exclusive license agreement to develop and commercialize motixafortide in Asia, with a concurrent equity investment. The license agreement includes a $15 million upfront payment, potential development, regulatory and sales milestones, and tiered double-digit royalties. The company also announced the initiation of a randomized Phase 2 clinical trial with Columbia University. The companys net loss for Q2 2023 was $18.5 million, compared to $7.4 million for Q2 2022.
PartnersInvestment
growth-positive
BioLineRx to Report Second Quarter 2023 Results on August 30, 2023
BioLineRx Ltd. will release its unaudited financial results for the quarter ended June 30, 2023. The company will host a conference call featuring remarks by the CEO. BioLineRx is a pre-commercial stage biopharmaceutical company pursuing therapies for cancers and rare diseases. They are advancing a pipeline of investigational medicines and have expertise in development and commercialization. The company is headquartered in Israel.
Management Changes
Growth-Positive
3 Cheap Biotech Stocks That Smart Investors Will Snap Up Now
The article discusses the potential growth of biotech companies, particularly Phathom Pharmaceuticals, Ardelyx, and BioLineRx, due to the increasing demand for better healthcare and the innovation in the sector. It mentions that many heavyweight companies are acquiring cheap biotech stocks to keep their pipelines fresh. Phathom Pharmaceuticals has been moving aggressively higher with its focus on gastrointestinal diseases and a potential market worth $5.95 billion by 2030. Ardelyx is also expected to grow with an upcoming FDA approval. BioLineRx, which has initiated a Phase 2 clinical trial in first-line metastatic pancreatic cancer, is also expected to grow.
InvestmentAcquisition
Growth-Positive
3 Smart Penny Stocks with Huge Potential
The article discusses the potential of three penny stocks - BioLine RX Ltd., SoundHound AI, and Sunworks. BioLine RX, a biotech company, has seen its stock price rise from $1.17 to $1.69 since May 4, with the FDA set to decide on the approval of its new drug for stem cell mobilization in September. SoundHound AI, which is working with the auto industry to integrate voice assistants into vehicles, has seen a 56% increase in revenue year over year due to a surge in demand for conversational AI. Sunworks, a solar company, has seen its stock price rise from $1.10 to $1.80 as the world increases spending on solar energy.
Investment
growth-positive
BioLineRx Announces Initiation of Randomized Phase 2 Clinical Trial in First Line Metastatic Pancreatic Cancer Based on Preliminary Data from Single-Arm Pilot Phase; Combination Trial Includes Investigational Candidate Motixafortide
BioLineRx Ltd., a biopharmaceutical company, has initiated a randomized, investigator-initiated Phase 2 clinical trial for first line metastatic pancreatic cancer. The trial is based on preliminary data from a single-arm pilot phase and includes the investigational candidate motixafortide. The study, sponsored by Columbia University, will compare combination treatment with motixafortide, a PD-1 inhibitor, and chemotherapy to chemotherapy alone in a larger number of patients. The companys New Drug Application for motixafortide in stem cell mobilization for autologous transplantation in multiple myeloma has been accepted by the FDA.
InvestmentExpand
growth-positive
BLRX: First Quarter Results
BioLineRx reported its 1Q:23 operational and financial results, highlighting the publication of the GENESIS Phase III clinical trial data in Nature Medicine. The company is focused on pre-commercialization activities for its drug motixafortide and is preparing for the upcoming target action date. BioLineRx also announced a collaboration with Washington University School of Medicine to evaluate motixafortide for gene therapy in sickle cell disease. The companys AGI-134 trial met its primary safety and tolerability endpoint, and data will be published in 2023. Upcoming milestones include data releases, presentations, and potential initiation of new studies. The market for motixafortide is significant, with opportunities in stem cell transplantation, pancreatic cancer, and gene therapy.
InvestmentExpand
growth-positive
BioLineRx Reports First Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates
BioLineRx Ltd., a pre-commercial-stage biopharmaceutical company, has reported its unaudited financial results for Q1 2023 and provided corporate and portfolio updates. The company is preparing for the potential approval and U.S. commercial launch of motixafortide in September 2023. The company has also hired a targeted sales force with expertise in high opportunity transplant centers. The companys cash, cash equivalents, and short-term bank deposits as of March 31, 2023, were $43.3 million. The company anticipates this will be sufficient to fund operations, as currently planned, into the first half of 2024.
InvestmentManagement ChangesExpand
growth-positive
BioLineRx to Report First Quarter 2023 Results on May 24, 2023
BioLineRx Ltd. announced that it will release its unaudited financial results for the quarter ended March 31, 2023. The company will host a conference call featuring remarks by the CEO. BioLineRx is a pre-commercial-stage biopharmaceutical company focused on oncology. Its lead development program, motixafortide, has shown promise in Phase 3 and Phase 2a studies for the treatment of multiple myeloma and metastatic pancreatic cancer, respectively. The company is also developing a second oncology program, AGI-134, for multiple solid tumors. The financial results and conference call are expected to have a positive impact on the companys growth. The event is scheduled for May 24, 2023.
Public Trading
7 High-Potential Penny Stocks in the Biotech Sector
growth-positive
BioLineRx Regains Compliance with Nasdaq Minimum Bid Price Requirement
BioLineRx has regained compliance with the minimum bid price requirement set forth by Nasdaq. The companys American Depository Shares (ADSs) will continue to be listed and traded on the NASDAQ Stock Market. The compliance notice was received on November 2, 2022, and the company had until May 1, 2023, to regain compliance. BioLineRx maintained a minimum closing bid price of $1.00 or more for 10 consecutive trading days from April 10, 2023, through April 21, 2023. The compliance status with the Tel Aviv Stock Exchange is unaffected.
Public Trading
growth-positive
BioLineRx Announces Publication in Nature Medicine of its GENESIS Phase 3 Clinical Trial Data Evaluating Motixafortide and G-CSF in Stem Cell Mobilization for Autologous Transplantation in Multiple Myeloma
BioLineRx Ltd., a pre-commercial-stage biopharmaceutical company, has announced the publication of data from its GENESIS Phase 3 clinical trial in the peer-reviewed journal Nature Medicine. The trial evaluated the safety and efficacy of the companys lead investigational candidate motixafortide plus granulocyte colony-stimulating factor (G-CSF) for the mobilization of hematopoietic stem cells in patients with multiple myeloma. The trial achieved statistical significance across all primary and secondary endpoints. A New Drug Application for motixafortide is currently under review with the U.S. Food and Drug Administration, with a decision expected by September 9, 2023.
Investment
The 3 Best Biotech Stocks Under $1 to Buy for April
BioLineRx Ltd. (NASDAQ:BLRX) Q4 2022 Earnings Call Transcript
BLRX: Confidence in a Strong Launch
growth-positive
BioLineRx Reports 2022 Financial Results and Recent Corporate and Portfolio Updates
BioLineRx Ltd., a biopharmaceutical company focused on oncology, has announced its 2022 annual financial results and recent corporate updates. The company has received FDA acceptance for its APHEXDA® (motixafortide) New Drug Application (NDA) in Stem Cell Mobilization. It has also appointed Tami Rachmilewitz, M.D., as its new Chief Medical Officer and completed the formation of its U.S. Commercial Leadership Team. Additionally, BioLineRx has entered into a clinical trial collaboration with Washington University School of Medicine to evaluate Motixafortide for Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease.
Management ChangesPartners
growth-positive
BioLineRx to Report 2022 Annual Financial Results on March 22, 2023
BioLineRx Ltd. will release its audited financial results for the year ended December 31, 2022 on March 22, 2023. The company will host a conference call featuring remarks by the CEO. BioLineRx is a pre-commercial-stage biopharmaceutical company focused on oncology, with lead development programs in motixafortide and AGI-134. Motixafortide has shown promise in Phase 3 and Phase 2a studies for multiple myeloma and metastatic pancreatic cancer, respectively. The companys NDA submission for motixafortide has been accepted by the FDA. BioLineRx is also developing AGI-134 as an immunotherapy treatment for multiple solid tumors.
Public Trading
growth-positive
BioLineRx Announces Clinical Trial Collaboration with Washington University School of Medicine to Evaluate Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease
BioLineRx has announced a collaboration with Washington University School of Medicine in St. Louis to conduct a Phase 1 clinical trial for its lead clinical candidate, motixafortide. The trial aims to evaluate the safety and feasibility of motixafortide in mobilizing CD34+ hematopoietic stem cells for gene therapies in sickle cell disease (SCD). The trial is part of BioLineRxs long-term growth strategy for motixafortide across multiple therapeutic areas. The company believes that motixafortide has broad potential in various therapeutic areas, including stem cell mobilization for multiple myeloma and treatment of pancreatic cancer. The trial is expected to begin enrollment in the second half of 2023.
Customers
growth-positive
BioLineRx Appoints Tami Rachmilewitz, M.D., as Chief Medical Officer
BioLineRx has appointed Tami Rachmilewitz, M.D. as Chief Medical Officer. Dr. Rachmilewitz brings over 15 years of clinical development industry experience, including overseeing clinical development programs in oncology, immunology, and neurodegeneration. Her appointment is expected to strengthen BioLineRxs mission to bring new medicines to patients. The company is focused on oncology and its lead development program, motixafortide, has shown positive results in clinical trials. BioLineRx is also developing a second oncology program, AGI-134. The appointment of Dr. Rachmilewitz is a growth-positive move for the company.
Management Changes
BioLineRx Highlights Early-Stage Trial Data From Cancer Vaccine Candidate
growth-positive
BioLineRx Announces Results from Phase 1/2a Study of Investigational Anti-Tumor Vaccine AGI-134 in Metastatic Solid Tumors
BioLineRx announced positive results from the Phase 1/2a study of its intratumoral cancer vaccine candidate, AGI-134. The study met its primary endpoint of safety and tolerability, with no dose-limiting toxicities reported. The recommended dose for the study was determined to be up to 200mg. The study also showed an increase in immune activity, as indicated by an increase in Alpha-Gal antibodies and the presence of antigen presenting cells and tumor infiltration. Additionally, 29% of patients achieved stable disease as the best overall response. BioLineRx plans to seek publication of the complete data analysis in 2023 and will determine the next steps for the program in the first half of next year.
Customers
BLRX: Self-Commercialization in the US
growth-positive
BioLineRx to Participate in the 12th Annual LifeSci Partners Corporate Access Event
BioLineRx Ltd., a pre-commercial-stage biopharmaceutical company focused on oncology, announced that management will participate in the 12th Annual LifeSci Partners Corporate Access Event. The event will take place on January 9-11, 2023, in San Francisco, CA. BioLineRx is developing a lead development program called motixafortide, which is a selective inhibitor of the CXCR4 chemokine receptor. The companys NDA submission for motixafortide has been accepted by the FDA with a PDUFA date of September 9, 2023. BioLineRx is also developing a second oncology program called AGI-134. The article does not mention any specific partners, investors, customers, or financial details.
Partners
growth-positive
BioLineRx Reports Third Quarter 2022 Financial Results and Recent Corporate and Portfolio Updates
BioLineRx Ltd., a pre-commercial-stage biopharmaceutical company, has announced the FDA acceptance of its New Drug Application (NDA) for APHEXDA® (motixafortide) in stem cell mobilization. The company plans to commercialize APHEXDA® independently in the U.S., if approved, and has appointed Holly May as President of BioLineRx USA. The company has also completed a $40M debt financing agreement with Kreos Capital and a $15M equity offering to support the aggressive commercial U.S. launch of APHEXDA®.
InvestmentManagement ChangesExpand
growth-positive
BioLineRx to Report Third Quarter 2022 Results on November 15, 2022
BioLineRx Ltd., a pre-commercial-stage biopharmaceutical company focused on oncology, will release its unaudited financial results for the quarter ended September 30, 2022. The company will host a conference call featuring remarks by the CEO. BioLineRxs lead development program, motixafortide, has shown positive results in studies for multiple myeloma and pancreatic cancer. The company is also developing a second oncology program, AGI-134. The event described in the article is the release of the financial results and the conference call.
Management Changes
growth-positive
BioLineRx Announces U.S. FDA Acceptance of New Drug Application for APHEXDA® (motixafortide) in Stem Cell Mobilization
BioLineRx has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for APHEXDA® (motixafortide) in stem cell mobilization for autologous transplantation in multiple myeloma patients. The FDA has set a target action date of September 9, 2023. The NDA is supported by the results from the GENESIS Phase 3 trial, which met all primary and secondary endpoints with a high level of statistical significance. BioLineRx believes that APHEXDA has the potential to become the standard of care in the multiple myeloma transplant setting. The company is actively preparing for a commercial launch.
Customers
growth-positive
BioLineRx Announces Successful Completion of Pre-NDA Meeting with FDA for Motixafortide for Stem Cell Mobilization in Multiple Myeloma Patients
BioLineRx has completed a successful pre-New Drug Application (NDA) meeting with the US Food and Drug Administration (FDA) regarding Motixafortide as a novel stem-cell mobilization agent for autologous bone marrow transplantation in multiple myeloma patients. The FDA agreed that the proposed data package is sufficient to support an NDA submission, which the company anticipates will occur in H1 2022. If approved, Motixafortide has the potential to become the standard-of-care mobilization therapy for all multiple myeloma patients undergoing autologous stem cell transplantation. BioLineRx is a late clinical-stage biopharmaceutical company focused on oncology.
Investment
growth-positive
BioLineRx Announces Positive Results from Pharmacoeconomic Study Positioning Motixafortide as Potential Standard of Care in Stem Cell Mobilization
BioLineRx Ltd., a late clinical-stage biopharmaceutical company, has announced positive results from a pharmacoeconomic study evaluating the cost-effectiveness of using investigational drug Motixafortide as a primary stem cell mobilization (SCM) agent on top of granulocyte colony stimulating factor (G-CSF), versus G-CSF alone, in multiple myeloma patients undergoing autologous stem cell transplantation (ASCT). The study concluded that the addition of Motixafortide to G-CSF is associated with a statistically significant decrease in health resource utilization (HRU) during the ASCT process, compared to G-CSF alone. The study findings suggest that the use of Motixafortide, on top of G-CSF, could be a cost-effective option in the US.
InvestmentManagement Changes
BioLineRx Ltd. - Consensus Indicates Potential 278.9% Upside
growth-positive
BioLineRx Announces Closing of $34.5 Million Bought Deal Offering and Full Exercise of the Option of the Underwriter
BioLineRx Ltd. has closed its underwritten offering of 14,375,000 American Depositary Shares (ADSs), raising approximately $34.5 million in gross proceeds. The company plans to use the net proceeds for general corporate purposes, including working capital and funding clinical trials. H.C. Wainwright & Co. acted as the sole book-running manager for the offering. BioLineRx is a late clinical-stage biopharmaceutical company focused on oncology. Their lead program, Motixafortide, is a cancer therapy platform that has shown promise in clinical trials. The company also has a second oncology program, AGI-134, currently being investigated in a Phase 1/2a study. BioLineRx follows a business model of in-licensing novel compounds, developing them through clinical stages, and partnering with pharmaceutical companies for further development and commercialization.
Investment
growth-positive
BioLineRx Announces $10 Million Bought Deal Offering
BioLineRx Ltd. has entered into an underwriting agreement with H.C. Wainwright & Co., LLC to purchase 4,166,667 American Depositary Shares (ADSs) of the company. The offering is expected to raise approximately $10 million in gross proceeds, which will be used for general corporate purposes and funding clinical trials. The closing of the offering is expected to occur on or about January 22, 2021. H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.
Investment
growth-positive
BioLineRx Announces Initiation of Phase 1b Clinical Trial in Patients with Acute Respiratory Distress Syndrome (ARDS) Secondary to COVID-19 and Other Respiratory Viral Infections
BioLineRx announced that its lead drug candidate, Motixafortide, will be evaluated in a clinical trial for patients with acute respiratory distress syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections. The study will be conducted at the Wolfson Medical Center in Israel. The primary endpoint is to assess the safety of Motixafortide in these patients, with respiratory parameters and inflammatory biomarkers as exploratory endpoints. Up to 25 patients will be enrolled, and preliminary results are expected in the first half of next year. BioLineRx believes that Motixafortide could be beneficial in blunting the cytokine storm associated with poor COVID-19 infection outcomes. The company also mentioned that it will announce full data from its Phase 2a study in pancreatic cancer and interim results from its Phase 2b study in AML by the end of this year.
Customers
growth-positive
BiolineRX soars on positive Phase 3 blood cancer trial results
BiolineRX Ltd. has reported positive results from an ongoing trial for stem cell mobilization in multiple myeloma patients. The trial, called Genesis Phase 3, is testing the efficacy of motixafortide. Following an interim analysis by the Data Monitoring Committee, the committee recommended that patient enrollment be halted due to statistically significant evidence favoring treatment with motixafortide. The study has enrolled a total of 122 patients, and full results are expected in the first half of 2021. BiolineRX sees this as a significant milestone for the company and hopes that the final results will support their goal of changing the treatment paradigm for stem cell mobilization in multiple myeloma patients.
Customers
growth-positive
BioLineRx Announces Notice of Allowance from USPTO for Patent Covering Motixafortide (BL-8040) in Combination With Anti-PD-1 for the Treatment of Any Type of Cancer
BioLineRx has received a Notice of Allowance from the USPTO for a patent application related to the use of motixafortide (BL-8040), a novel immunotherapy compound, combined with any PD-1 inhibitor for the treatment of any type of cancer. The patent will be valid until July 2036 with a possibility of up to five years patent term extension. The company is conducting a Phase 2a study, COMBAT/KEYNOTE-202, to evaluate the safety, tolerability, and efficacy of motixafortide, KEYTRUDA, and chemotherapy. The study is being conducted under a collaboration agreement with MSD. BioLineRx is a clinical-stage biopharmaceutical company focused on oncology.
PartnersCustomers
growth-positive
EU grants BiolineRX treatment orphan drug status
BiolineRX Ltd. has received Orphan Drug Designation from the European Commission for its lead oncology candidate, Motixafortide, for the treatment of pancreatic cancer. This designation is of significant strategic importance for the development of BiolineRXs lead product. Motixafortide is currently being evaluated in a Phase IIa study for the treatment of pancreatic cancer in combination with KEYTRUDA and chemotherapy under a collaboration agreement with Merck & Co., Inc.
Partners
growth-negative
BiolineRX falls despite pancreatic cancer trial success
Israeli drug developer BiolineRX announced the full results of its trial for the treatment of pancreatic cancer. The trial showed that 32% of patients treated with BiolineRXs drug showed improvement and 45% were stable, which is better than the prevailing treatment. However, the companys share price dropped 12% after the announcement, resulting in a decrease in market cap. BiolineRX has faced challenges in its drug development projects and currently has a single leading product, BL-8040. The company has also undergone changes in its ownership structure, with BVF Partners being the leading shareholder.
Customers
growth-positive
Phase 1/2 Trial of Immunotherapy AGI-134 to Open to US Patients...
BioLineRx has received approval from the U.S. Food and Drug Administration to expand the Phase 1/2 clinical trial of its investigational drug AGI-134. The trial, which is testing AGI-134 alone and in combination with Keytruda, will now include sites in the U.S. in addition to the current sites in the U.K. and Israel. The study aims to evaluate the safety, tolerability, and efficacy of AGI-134 in patients with solid tumors who have not responded to other therapies. Early efficacy results are expected to be released in late next year. AGI-134 is a man-made fatty molecule that uses the bodys defense mechanisms against bacteria to kill cancer cells. The FDA granted BioLineRx a 12-year market exclusivity if AGI-134 is approved for cancer treatment in the U.S.
Expand
growth-positive
BioLineRx Announces Successful Engraftment Data From Phase 3 GENESIS Trial for BL-8040 in Multiple Myeloma Patients
BioLineRx announced successful engraftment of hematopoietic stem cells (HSCs) in multiple myeloma patients participating in the GENESIS trial. The trial compared the combination of BL-8040 and G-CSF to G-CSF alone for mobilization of HSCs for autologous transplantation. The results showed that mobilizing HSCs with BL-8040 and G-CSF was highly effective, requiring fewer injections and apheresis days compared to G-CSF alone. Successful engraftment was observed in all patients. The results were presented at the European Society for Blood and Marrow Transplantation conference. The findings are encouraging and may have a positive impact on the growth of BioLineRx.
CustomersPartners
growth-positive
BioLineRx Announces Initiation of Phase 1b/2 Trial for BL-8040 in AML Under Immunotherapy Collaboration
BioLineRx has announced the initiation of a Phase 1b/2 trial for BL-8040 in combination with atezolizumab for the maintenance treatment of patients with acute myeloid leukemia (AML). The trial is part of BioLineRxs cancer immunotherapy collaboration with Genentech, a member of the Roche Group. The study aims to evaluate the relapse-free survival, minimal residual disease status, safety, and tolerability of the combination therapy. The trial is planned to take place at approximately 22 sites in the U.S., Europe, and Israel. BioLineRx is hopeful that combining atezolizumab with BL-8040 will establish a new treatment for AML patients that extends the duration of remission following induction treatment. The company plans to initiate additional combination studies under this collaboration by the end of the year.
PartnersCustomers
growth-positive
BiolineRx buys UK co Agalimmune
BiolineRx has announced the acquisition of Agalimmune, a UK-based company with an innovative immunotherapy platform for treating cancer. BiolineRx is paying $6 million upfront for the acquisition. The acquisition is seen as a growth-positive move for BiolineRx. The key theme of the article is the acquisition of Agalimmune by BiolineRx. The key issues discussed in the article are the acquisition and the development of cancer therapies. The article does not mention any specific customers. The date of the event described in the article is March 23, 2017. My confidence in this answer is 8/10.
Acquisition
growth-positive
BioLineRX boosted by liver disease drug acquisition
BioLineRX has announced the acquisition of a drug to treat liver failure, which is the second project in-licensed under its strategic collaboration with Novartis. The companys share price rose 22% initially but has since fallen back 2.4%. BioLineRX is developing the drug up to the human clinical trials stage, and Novartis will decide whether to take it for further development. The companys leading product is a leukemia treatment currently in Phase IIb trials. The market for liver disease treatments has been active recently, with Allergans acquisition of Tobira Therapeutics for $1.7 billion. BioLineRXs drug is intended for the treatment of liver failure, which can arise from fatty liver disease or other diseases.
PartnersInvestment
growth-positive
BioLineRx Names Philip A. Serlin as Chief Executive Officer
BioLineRx has announced the appointment of Philip A. Serlin as the new Chief Executive Officer, effective October 10, 2016. Serlin, who joined the company in 2009 as its Chief Financial and Operating Officer, will succeed Kinneret Savitsky, who has served as CEO since 2010. Savitsky will continue to serve as a scientific advisor until March 2017. Additionally, Mali Zeevi has been appointed as the new Chief Financial Officer. BioLineRx is a clinical-stage biopharmaceutical company focused on identifying and developing therapeutic candidates. The company has leading candidates in cancer therapy and celiac disease, as well as strategic collaborations with Novartis and MSD.
Management Changes
growth-positive
BioLineRx reports positive Phase II leukemia trial
Israeli drug development company BiolineRX Ltd. has reported positive top-line results from BL-8040�s Phase II clinical trial in relapsed or refractory acute myeloid leukemia. The results showed that BL-8040 was safe and well tolerated, with a 38% complete remission rate. The data also suggest a correlation between improved clinical response and patients with a high disease burden in the bone marrow. BiolineRX plans to meet with regulatory authorities to discuss the next steps in the development of this program.
Customers
growth-positive
BiolineRx, Merck agree cancer drugs collaboration
BiolineRX will conduct a Phase II trial of a combination of Mercks KEYTRUDA and its BL-8040 in treating pancreatic cancer. The collaboration with Merck is expected to expand the benefit of immunotherapy to cancer types currently resistant to immuno-oncology treatments. The trial is scheduled for mid-year and will evaluate the safety and efficacy of the combination therapy. BiolineRXs share price increased following the announcement of the collaboration.
Partners
growth-positive
BioLineRX signs Novartis strategic cooperation deal
Novartis will invest $10 million in BioLineRX for a 12.8% stake. They will select three projects for joint development.
Investment
Employee Info
| Employees (range) | 51-200 |
| Exact count | 54 |
| Team members | 2 |
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Admin Info
| Confidence | 92/100 |
| Missing | markets, not claimed |
| BI Verification | Yanina Wainscheinker |
| Registrar ID | 513398750 |
| Crunchbase | biolinerx |
| Phone | +97286429100 |
| Creator | Arielle Smolin |
| Creator email | ari.smolin@gmail.com |
| Last updater | Matan Eblagon |
| Updater email | matane@sncentral.org |
| Last update | 2024-06-30T00:00:00.000Z |
| Created | 2014-07-14T00:00:00.000Z |
| Status detail | Public on TASE on Apr, 2007;Public on NASDAQ on Mar, 2014; |