Welcome to our dedicated page for Beigene news (Ticker: BGNE), a resource for investors and traders seeking the latest updates and insights on Beigene stock.
News about BeiGene, Ltd. (BGNE) centers on its role as a global oncology company advancing cancer medicines such as TEVIMBRA (tislelizumab) and BRUKINSA (zanubrutinib), along with a broad pipeline of solid tumor and hematology assets. The company’s announcements frequently cover regulatory milestones, clinical trial readouts, licensing deals and strategic updates tied to its oncology focus.
Recent news highlights include positive regulatory developments for TEVIMBRA, such as a positive opinion from the Committee for Medicinal Products for Human Use for first-line treatment of extensive-stage small cell lung cancer in combination with chemotherapy, European Commission approvals in first-line esophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma, and U.S. Food and Drug Administration approval for first-line treatment of certain HER2-negative gastric and gastroesophageal junction cancers. These stories typically detail Phase 3 trial results, overall survival outcomes and safety profiles.
BeiGene’s news flow also features updates from major scientific meetings, including new data from the SEQUOIA study of BRUKINSA in chronic lymphocytic leukemia/small lymphocytic lymphoma, early-phase results for sonrotoclax and BGB‑16673 in B‑cell malignancies, and broader pipeline presentations at forums such as the American Society of Hematology Annual Meeting. Additional items include a global licensing agreement for the MAT2A inhibitor SYH2039 for MTAP-deleted solid tumors and partnerships like the Test Before Treat campaign with CLL Society to promote biomarker testing in CLL/SLL.
Investors and followers of BGNE can use this news page to track regulatory decisions, clinical data releases, business development agreements, investor conference appearances and corporate identity plans, including BeiGene’s stated intent to change its name to BeOne Medicines Ltd. and its Nasdaq ticker symbol to ONC.
BeiGene (NASDAQ: BGNE) announced its participation in the J.P. Morgan 41st Annual Healthcare Conference, scheduled for January 9, 2023, at 1:30 p.m. PT. A live webcast will be available on the investors section of BeiGene's website, with an archived replay accessible for 90 days post-event. The company is a global biotechnology firm focused on developing innovative oncology treatments to improve accessibility and outcomes for patients worldwide. With over 9,000 employees globally, BeiGene aims to enhance treatment access for numerous patients.
BeiGene announced that the Center for Drug Evaluation of China has accepted a supplemental biologics license application for tislelizumab as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC). The sBLA is underpinned by data from the RATIONALE 301 clinical trial, which involved 674 participants across Asia, Europe, and the US. HCC has a poor prognosis, particularly in China, where survival rates are low. Tislelizumab is already approved in China for other indications and aims to expand treatment access for HCC patients.
BeiGene announced the final results of the ALPINE trial, demonstrating that BRUKINSA has superior progression-free survival (PFS) compared to IMBRUVICA in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The trial involved 652 patients globally; BRUKINSA achieved a PFS rate of 78.4% at 24 months versus 65.9% for IMBRUVICA. Additionally, BRUKINSA exhibited a favorable cardiac safety profile, with fewer cardiac events leading to treatment discontinuation. The FDA is currently reviewing the supplemental New Drug Application (sNDA) for BRUKINSA, with a decision expected by January 20, 2023.
Phanes Therapeutics has entered a clinical supply agreement with BeiGene (NASDAQ: BGNE) to study PT199, an anti-CD73 monoclonal antibody, in combination with BeiGene's tislelizumab for advanced solid tumors. The Phase I clinical trial (NCT05431270) will assess the safety and efficacy of this combination in patients who have not responded to standard treatments. PT199 is designed to inhibit immunosuppressive environments in tumors and aims to enhance antitumor immune responses.
BeiGene announced the final progression-free survival (PFS) results from the ALPINE trial, comparing BRUKINSA (zanubrutinib) with IMBRUVICA (ibrutinib) in relapsed/refractory CLL and SLL patients. The findings, to be presented at the American Society of Hematology (ASH) Annual Meeting on December 13, 2022, showed superior PFS for BRUKINSA (HR: 0.65). With nearly 30 months of follow-up, BRUKINSA demonstrated a favorable safety profile and lower discontinuation rates compared to ibrutinib. Investor events will be held in New Orleans and via webcast.
BeiGene has received European Commission approval for BRUKINSA (zanubrutinib) to treat adult patients with chronic lymphocytic leukemia (CLL), expanding its treatment options for both treatment-naïve and relapsed/refractory cases. BRUKINSA demonstrated superior efficacy compared to IMBRUVICA in clinical trials, achieving an overall response rate of 80.4% versus 72.9%. The drug also has a favorable safety profile with lower rates of atrial fibrillation. This approval opens up significant growth opportunities for BeiGene in the European market.
BeiGene (NASDAQ: BGNE) has received approval in location value="LC/br"Brazil for BRUKINSA (zanubrutinib) to treat adult patients with Waldenström’s macroglobulinemia (WM) and relapsed/refractory marginal zone lymphoma (MZL). This follows its previous approval for mantle cell lymphoma (MCL). BRUKINSA is designed for targeted BTK inhibition and supports a broad clinical program, with over 4,700 subjects in 35 trials globally. It is now approved in 58 markets, enhancing access to innovative cancer treatments worldwide.
BeiGene reported strong financial results for Q3 2022, with product revenue of $349.5 million, an 82% increase from the prior year. Key products, BRUKINSA and tislelizumab, generated revenues of $155.5 million and $128.2 million, respectively. BRUKINSA demonstrated superior Progression-Free Survival compared to IMBRUVICA in its Phase 3 ALPINE trial. Despite a net loss of $557.6 million, the company maintains a robust cash position of $5.1 billion for future investments and growth.
BeiGene has announced its participation in two investor conferences: the 6th Annual Cowen IO Next Virtual Conference on November 11 at 9:40 a.m. ET and the 13th Annual Jefferies Global Healthcare Conference on November 16 at 11:25 a.m. ET. A live webcast will be available on BeiGene's investor website, with an archived replay accessible for 90 days post-event. BeiGene is dedicated to developing affordable oncology medicines and operates globally with over 9,000 employees across multiple locations including Beijing, Cambridge, and Basel.
BeiGene, a global biotechnology company, announced the acceptance of 15 abstracts for the upcoming American Society of Hematology (ASH) Annual Meeting from December 10-14, 2022, in location value="LU/us.la.nworln"New Orleans. Among the highlights are three oral presentations focusing on BRUKINSA (zanubrutinib) and the novel Bcl-2 inhibitor BGB-11417. These findings showcase significant progress in developing treatments for B-cell malignancies. An investor event is scheduled for December 11, at 8:00 PM CST to discuss the data presented.