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: BLRX) is a commercial-stage biopharmaceutical company based in Modi'in, Israel, with operations extending to the United States. The company specializes in developing life-changing therapies for oncology and rare diseases. BioLineRx's flagship product, APHEXDA® (motixafortide), has gained approval in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma patients.
Currently, the company is advancing a robust pipeline of investigational medicines targeting sickle cell disease, pancreatic cancer, and other solid tumors. One of their notable clinical-stage therapeutic candidates is motixafortide (BL-8040), a novel peptide showing promise in stem-cell mobilization and solid tumors. Another key candidate is AGI-134, an immuno-oncology agent dedicated to treating solid tumors.
BioLineRx recently announced definitive agreements with institutional investors for the issuance and sale of its American Depositary Shares (ADSs) and warrants. This equity transaction, combined with financial resources from an existing debt facility, positions the company well for the commercialization of APHEXDA and the advancement of its other pipeline programs. Additionally, the company is exploring motixafortide's potential in supporting gene therapy for sickle cell disease, collaborating with leaders in the gene therapy field such as St. Jude Children's Research Hospital and Washington University School of Medicine.
BioLineRx has also received recent notifications and presented new data at various esteemed conferences such as the American Society of Clinical Oncology (ASCO) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). These efforts underscore the company's commitment to bringing innovative therapies from the bench to the bedside.
To access more information about BioLineRx, visit their official website or follow them on Twitter and LinkedIn.
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.
BioLineRx (NASDAQ: BLRX) reported its Q1 2024 financial results and recent corporate updates. The company highlighted steady growth in APHEXDA® adoption, securing formulary placement at institutions representing ~26% of stem cell transplant procedures, targeting 35% by end of Q2. Key developments include new data presented at ASCO 2024 from a Phase 2b pancreatic cancer trial, and the approval of a motixafortide HSC mobilization study in China. Financials showed $6.9 million in total revenue and a net loss of $0.7 million, a significant improvement from a $12.2 million loss in Q1 2023. The company completed $26 million in debt and equity financing to support U.S. commercialization of APHEXDA.
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