Welcome to our dedicated page for BeiGene, Ltd. news (Ticker: BGNE), a resource for investors and traders seeking the latest updates and insights on BeiGene, Ltd. stock.
BeiGene, Ltd. (NASDAQ: BGNE) is a global biotechnology company specializing in the development and commercialization of innovative cancer treatments. With a robust portfolio focused on molecularly targeted and immuno-oncology drugs, BeiGene addresses crucial oncology targets such as Bruton's tyrosine kinase (BTK) and the immune checkpoint protein PD-1. The company’s notable products include tislelizumab, a PD-1 inhibitor, and zanubrutinib, a BTK inhibitor, which have shown promising results in treating various cancers. BeiGene’s latest achievements include FDA and European regulatory approvals, significant clinical trial successes, and partnerships aimed at expanding the reach of their therapies globally. The company operates across major markets, including China, the United States, and internationally, striving to make high-quality cancer treatments more accessible. BeiGene’s commitment to advancing global health equity is evident in its innovative drug pipeline and strategic collaborations.
BeiGene (NASDAQ: BGNE) has opened its flagship U.S. facility in Hopewell, N.J., representing an $800 million investment in biologics manufacturing and clinical R&D capabilities. The 42-acre site features 400,000 square feet of commercial-stage biologic pharmaceutical manufacturing capacity, with room for expansion. This facility enhances BeiGene's ability to produce innovative cancer medicines at scale, reduce costs, and ensure supply chain resiliency.
The company plans to create hundreds of skilled high-tech jobs by the end of 2025. The site includes sustainability measures such as a heating and cooling system using recycled wastewater and is solar-ready. This expansion supports BeiGene's global growth strategy and strengthens its position as a leading oncology innovator with over 30 molecules at clinical or commercial stage.
BeiGene, (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) has appointed Aaron Rosenberg as Chief Financial Officer, effective July 22. Rosenberg, with over 20 years of experience at Merck & Co., replaces Julia Wang, who is departing to pursue external opportunities. This change comes during a transformative year for BeiGene, now a top 15 global oncology innovator by revenue with progress towards profitability and a robust pipeline.
Rosenberg's most recent role was Senior Vice President and Corporate Treasurer at Merck. His experience includes leading enterprise-wide business transformation and heading Financial Planning & Analysis. BeiGene's CEO, John V. Oyler, expressed confidence in Rosenberg's ability to support the company's growth and reinforce its global leadership in hematology and other cancer treatments.
BeiGene presented new data from the SEQUOIA study at EHA2024, evaluating BRUKINSA® (zanubrutinib) with venetoclax in high-risk, treatment-naïve patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) with del(17p) and/or TP53 mutation.
In 65 response-evaluable patients, the overall response rate (ORR) was 100%, with a 48% complete response (CR) and CR with incomplete hematopoietic recovery (CRi). The median follow-up was 31.6 months, with 12- and 24-month progression-free survival (PFS) rates of 95% and 94%, respectively. Safety profiles were consistent with prior studies.
Common adverse effects included infections, COVID-19, and diarrhea. High-risk tumor lysis syndrome (TLS) decreased significantly. The findings support BRUKINSA's efficacy and tolerability in high-risk patients.
BeiGene (NASDAQ: BGNE) and NewBridge Pharmaceuticals have agreed to end their partnership for BRUKINSA® (Zanubrutinib) in the MENA region, effective by March 31, 2025. This decision aligns with BeiGene's strategy to expand its direct operations in the area. The partnership, initiated in 2020, facilitated BRUKINSA's approval and market presence in multiple territories. From June 11, 2024, BeiGene will assume all customer-facing activities, including Medical Affairs, Commercial Operations, and Market Access, using an expanded regional team. The agreement marks a pivotal step in BeiGene's goal to enhance cancer treatment availability and support its global growth aspirations.
BeiGene, a global oncology company, announced its participation in the Goldman Sachs 45th Annual Global Healthcare Conference on June 11, 2024. The event will feature a fireside chat at 1:20 pm EDT, accessible via live webcast through BeiGene's investor relations websites. The replay will be available for 180 days post-event.
BeiGene announced new analyses for BRUKINSA® (zanubrutinib) at the ASCO Annual Meeting 2024. The data underline BRUKINSA's efficacy and safety in treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) compared to other BTK inhibitors (BTKis).
A network meta-analysis highlighted BRUKINSA's superior progression-free survival (PFS) over acalabrutinib in high-risk relapsed/refractory CLL patients. Additional findings indicated a trend towards better overall survival (OS) and overall response (ORR) rates.
A retrospective analysis from Kaiser Permanente revealed that BRUKINSA is well-tolerated, with lower treatment-limiting adverse events, particularly cardiac-related, compared to ibrutinib. A post-hoc analysis of the ALPINE trial showed patients on BRUKINSA had less frequent initiation of new antihypertensive medications.
Overall, BRUKINSA demonstrates a favorable clinical profile, offering significant insights for oncologists in treatment decision-making for CLL and SLL patients.
BeiGene announced it will present new data from its hematology portfolio at the European Hematology Association 2024 Hybrid Congress (EHA2024) in Madrid, Spain, June 13-16, 2024.
Highlights include 28 abstracts, with four oral presentations. Key studies focus on BRUKINSA® (zanubrutinib), sonrotoclax, and BGB-16673. BRUKINSA, in combination with venetoclax, showed strong efficacy and favorable safety in high-risk CLL/SLL patients.
Sonrotoclax demonstrated promising safety and efficacy as a monotherapy and in combination therapies, particularly with BRUKINSA. Also, BGB-16673, a BTK degrader, showed encouraging results in BTK inhibitor-resistant diseases.
These findings underscore BeiGene's commitment to advancing treatment options for B-cell malignancies and other hematological conditions.
BeiGene reported total revenues of $752 million in the first quarter of 2024, with product revenue reaching $747 million, an 82% increase from the prior-year period. BRUKINSA revenue was $489 million, showcasing growth in the U.S. and Europe. The company is focusing on advancing its late-stage hematology pipeline, improving operating leverage, and aiming for sustainable profitability. Key updates include the FDA approval for BRUKINSA in follicular lymphoma and the sales growth of TEVIMBRA in various indications. The company also highlighted progress in its hematology and solid tumor programs, along with key pipeline advancements in lung, breast, and gastrointestinal cancers.
BeiGene, a global oncology company, released its 2023 Responsible Business & Sustainability Report, highlighting achievements, expansion plans, and commitment to innovation. Key points include treating over 1 million patients with BTK inhibitor BRUKINSA and anti-PD-1 antibody TEVIMBRA, opening a new facility in the U.S., and setting quantitative climate goals. The report focuses on advancing global health, empowering colleagues, innovating sustainably, and operating responsibly.
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