Welcome to our dedicated page for Biolinerx news (Ticker: BLRX), a resource for investors and traders seeking the latest updates and insights on Biolinerx stock.
BioLineRx Ltd (NASDAQ/TASE: BLRX) is a clinical-stage biopharmaceutical company advancing innovative therapies in oncology and rare diseases, including its FDA-approved stem cell mobilizer APHEXDA®. This page provides centralized access to official company announcements, clinical trial updates, and strategic partnership developments.
Investors and researchers will find verified updates on pipeline progress, regulatory milestones, and operational initiatives. Content includes earnings reports, clinical data publications, licensing agreements, and manufacturing updates, all sourced directly from BioLineRx communications.
Regularly refreshed with new developments, this resource enables stakeholders to track the company’s work in areas like multiple myeloma treatment optimization and sickle cell disease gene therapy research. Bookmark this page for efficient monitoring of BLRX’s advancements in targeted drug development and commercialization strategies.
BioLineRx (Nasdaq: BLRX) has announced a $10 million registered direct offering of 50,000,000 American Depositary Shares (ADSs) at $0.20 per ADS. The offering includes accompanying warrants to purchase up to 50,000,000 additional ADSs at an exercise price of $0.20 per share, exercisable immediately and expiring in five years.
Each ADS represents fifteen ordinary shares of BioLineRx. The offering is expected to close around January 7, 2025, with H.C. Wainwright & Co. serving as the exclusive placement agent. The company plans to use the net proceeds for research and development activities, pipeline expansion, working capital, and general corporate purposes.
The offering is being made through a shelf registration statement filed with the SEC on December 29, 2023, and declared effective on January 5, 2024.
BioLineRx reported Q3 2024 financial results and strategic updates. Key highlights include a $10 million upfront license agreement with Ayrmid for APHEXDA®, with potential commercial milestones up to $87 million and 18-23% tiered royalties. The company received a $9 million equity investment from Highbridge Capital Management and restructured $16.5 million of long-term debt. Q3 revenue was $4.9 million, with a net loss of $5.8 million. Annual operational expenses are expected to decline by over 70% following the APHEXDA® commercial program transfer.
BioLineRx has entered into a license agreement with Ayrmid for APHEXDA® (motixafortide), receiving a $10 million upfront payment plus potential $87 million in commercial milestones and 18-23% royalties on net sales. The agreement grants Ayrmid exclusive rights to commercialize APHEXDA in all territories except Asia and solid tumor indications. Additionally, BioLineRx secured a $9 million equity investment from Highbridge Capital Management funds. The deal allows BioLineRx to reduce operational expenses while maintaining development rights for motixafortide in solid tumors, including PDAC studies with Columbia University and Gloria Biosciences.
BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company focused on oncology and rare diseases, has announced it will release its Q3 2024 financial results on November 25, 2024, before U.S. markets open. The company will host a conference call at 8:30 a.m. EST, featuring CEO Philip Serlin. The call will be accessible via phone and webcast through the company's website, with replay available until November 27, 2024.
BioLineRx (NASDAQ: BLRX) announced positive initial results from a Phase 1 clinical trial evaluating motixafortide for stem cell mobilization in sickle cell disease (SCD) gene therapies. The study showed that motixafortide, both alone and combined with natalizumab, was safe and well-tolerated, potentially enabling collection of required stem cells in a single apheresis cycle. Motixafortide alone mobilized 198 CD34+ cells/μl median, while the combination achieved 231 CD34+ cells/μl. Notably, patients experienced 2.8-fold greater stem cell mobilization with motixafortide alone and 3.2-fold greater with the combination compared to current standard plerixafor.
BioLineRx (NASDAQ/TASE: BLRX) has received a Notice of Allowance from the USPTO for a new Composition of Matter patent on motixafortide (APHEXDA®/BL-8040). This patent strengthens BioLineRx's intellectual property estate and extends patent protection for motixafortide in the U.S. through December 2041.
The patent reflects the unique attributes of motixafortide as a mobilization agent for multiple myeloma patients undergoing autologous stem cell transplantation, as well as its potential in other indications like pancreatic cancer and gene therapies for sickle cell disease.
BioLineRx also has Orphan Drug market exclusivity for APHEXDA® until September 2030 and five years of data exclusivity as a New Chemical Entity. Motixafortide has Orphan Drug Designation in the U.S. and Europe for pancreatic cancer treatment and in the U.S. for acute myeloid leukemia treatment.
BioLineRx (NASDAQ: BLRX) has launched 'Mobilization Matters', a digital resource for multiple myeloma patients preparing for stem cell collection. The platform, launched on Apheresis Awareness Day, offers patient stories, educational resources, and a discussion guide to support patients undergoing this critical treatment phase.
In partnership with the HealthTree Foundation, BioLineRx is conducting the Mobilization Matters Stem Cell Collection Survey to gather patient insights about their experiences with stem cell collection and apheresis. Survey results are expected in Q1 2025. The initiative aims to enhance understanding and improve care strategies for multiple myeloma patients undergoing stem cell collection.
BioLineRx (NASDAQ: BLRX) reported its Q2 2024 financial results and recent updates. Key highlights include:
- Secured APHEXDA® formulary placement among top 80 transplant centers representing ~37% of stem cell transplant procedures, surpassing Q2 goal
- Doubled the number of centers ordering APHEXDA during Q2
- Entered clinical trial agreement with St. Jude Children's Research Hospital for motixafortide in sickle cell disease
- Q2 revenue: $5.4 million, including $1.8 million from APHEXDA sales
- Net income: $0.5 million, compared to net loss of $18.5 million in Q2 2023
- Cash position: $40.1 million as of June 30, 2024, expected to fund operations into 2025
BioLineRx (NASDAQ: BLRX), a commercial stage biopharmaceutical company focusing on oncology and rare diseases, will announce its second quarter 2024 financial results on August 15, 2024, before the U.S. markets open.
The company will host a conference call at 8:30 a.m. EDT on the same day, featuring remarks by CEO Philip Serlin. Investors can join the call by dialing +1-888-281-1167 (U.S.) or +972-3-918-0685 (international).
A live webcast and replay of the call will be available on the company's website. The replay can also be accessed by dialing +1-888-295-2634 (U.S.) or +972-3-925-5904 (international) until August 19, 2024.
BioLineRx (NASDAQ: BLRX, TASE: BLRX) announced a Phase 1 clinical trial in collaboration with St. Jude Children's Research Hospital to evaluate motixafortide for mobilizing CD34+ hematopoietic stem cells (HSCs) in gene therapies for sickle cell disease (SCD). This study includes experts from St. Jude and two other clinical sites, focusing on new mobilization options due to the limitations of current strategies, like plerixafor, which require multiple cycles. Enrollment is set to start in a few months, and initial data from a related trial at Washington University is expected in late 2024. Motixafortide, BioLineRx's leading candidate, was FDA-approved in September 2023 for HSC mobilization in multiple myeloma patients.
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