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) has been added to several FTSE Russell indices, including the FTSE Global Equity Index Large Cap and FTSE Developed ESG Low Carbon Select Index, effective September 17, 2021. This inclusion enhances the company's visibility in the global investment community and supports its commitment to sustainability. BeiGene aims to increase access to cancer treatments globally and has a goal to radically improve access to medicines for two billion people by 2030. CEO John V. Oyler and ESG Lead Christine Riley Miller emphasized the company's dedication to innovative and equitable health solutions.
BeiGene's European commercial team is preparing to launch BRUKINSA, its first medicine submitted for EU marketing authorization, pending approval. The CHMP has recommended approval for BRUKINSA (zanubrutinib) for adult patients with Waldenström’s macroglobulinemia, based on the Phase 3 ASPEN trial results. BRUKINSA showed a higher very good partial response rate and a favorable safety profile compared to ibrutinib. The final decision by the European Commission is expected within 67 days.
BeiGene announced FDA's accelerated approval for BRUKINSA (zanubrutinib) to treat adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20 regimen. This marks the third FDA approval for BRUKINSA, showing a 56% overall response rate and 20% complete remission in a pivotal trial. The drug demonstrated a good safety profile. Continued approval is contingent upon further clinical trials.
BeiGene has announced that the FDA has accepted its Biologics License Application (BLA) for tislelizumab, an anti-PD-1 antibody aimed at treating unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior therapy. This marks a significant step in their strategy to expand treatment options globally, having previously secured approval for tislelizumab in five indications in China. The PDUFA target action date is July 12, 2022, and the submission is backed by positive results from the global Phase 3 RATIONALE 302 trial.
BeiGene, Ltd. (NASDAQ: BGNE) announced the presentation of clinical results from its lung cancer program at the ESMO Congress 2021. The company is focused on enhancing its immuno-oncology portfolio, particularly through the combination of tislelizumab with investigational agents like ociperlimab and sitravatinib. Various Phase 3 trials are currently in progress, addressing non-small cell lung cancer (NSCLC). Subgroup analyses reveal consistent survival benefits with tislelizumab, regardless of patient characteristics. BeiGene aims to improve outcomes for NSCLC patients worldwide.
BeiGene announced FDA approval for BRUKINSA (zanubrutinib) as a treatment for adult patients with Waldenström's macroglobulinemia. This marks the second indication for BRUKINSA in the U.S. and its third globally. The approval follows the Phase 3 ASPEN trial, which demonstrated improved efficacy and tolerability compared to ibrutinib. Key results showed a VGPR rate of 28% for BRUKINSA versus 19% for ibrutinib. The company continues to expand its global clinical program, solidifying its commitment to innovate in B-cell malignancies.
BeiGene announces that the China National Medical Products Administration (NMPA) has accepted a supplemental Biologics License Application (sBLA) for tislelizumab in combination with chemotherapy as a first-line treatment for recurrent or metastatic nasopharyngeal cancer (NPC). This milestone, supported by positive results from the RATIONALE 309 trial, highlights the need for effective treatment options in a cancer type that predominantly affects patients in China. Tislelizumab has received multiple approvals in China across various indications, showcasing its expanding therapeutic potential.
BeiGene has received conditional approval from the China National Medical Products Administration (NMPA) for QARZIBA® (dinutuximab beta) to treat high-risk neuroblastoma in children aged 12 months and older. This therapy is indicated for those who've undergone chemotherapy and myeloablative treatment. Clinical trials showed significant efficacy, with a five-year event-free survival rate of 57% compared to 42% of historical controls. Despite the approval, common adverse reactions include fever and pain, raising considerations regarding patient management.
BeiGene, Ltd. (NASDAQ: BGNE) announced an investor conference call on August 25, 2021, at 9:30 a.m. ET to discuss its early development pipeline and research initiatives. The event will be accessible via a live webcast on BeiGene’s investor website, with an archived replay available for 90 days post-event. BeiGene is committed to innovative and affordable medicines aimed at enhancing patient access, with a portfolio of over 40 clinical candidates and a goal of improving access for two billion people by 2030. The company has a global team of around 7,000 employees.
BeiGene reported strong advancements in its oncology drug portfolio, showcasing significant growth in product sales, particularly for BRUKINSA, which generated $42.4 million, up from $7.0 million YoY. Their second quarter revenue reached $150 million, a substantial increase from $65.6 million in 2020. The company highlighted positive interim results from key trials, including SEQUOIA and ALPINE, and secured conditional approvals for treatments in multiple markets. However, a net loss of $480.3 million was noted, a wider loss per share of $0.40 compared to $0.33 in Q2 2020.