$BGNE News

Last published 2mo ago

2mo agoBGNEApproval of Tevimbra, Bla #761232FDA Approved DrugsApproval Date: 08/25/2026; Drug Name: Tevimbra, Bla #761232; Active Ingredients: TISLELIZUMAB-JSGR; Company: Beigene; Submission Status: Approval; Application Number: 761232
1y agoBGNE ONCBeiGene Receives Positive CHMP Opinion for TEVIMBRA® as a First-Line Treatment for Extensive-Stage Small Cell Lung CancerBusiness WirePositive opinion for first-line treatment of extensive-stage small cell lung cancer based on results of RATIONALE-312 study demonstrating statistically significant overall survival benefit for TEVIMBRA in combination
1y agoBGNETEVIMBRA Approved in U.S. for First-line Treatment of Gastric and Gastroesophageal Junction Cancers in Combination with ChemotherapyBusiness WireNew indication based on results from a global Phase 3 trial demonstrating TEVIMBRA plus chemotherapy significantly improved overall survival for patients with advanced gastric cancers Second FDA approval for TEVIMBRA
1y agoBGNEApproval of Tevimbra, Bla #761417FDA Approved DrugsApproval Date: 12/26/2024; Drug Name: Tevimbra, Bla #761417; Active Ingredients: TISLELIZUMAB-JSGR; Company: Beigene; Submission Status: Approval; Application Number: 761417
1y agoBGNEBeiGene to Change Nasdaq Ticker Symbol to "ONC" on January 2; Present at 43rd Annual J.P. Morgan Healthcare ConferenceBusiness WireBeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160, SSE: 688235)), a global oncology company that intends to change its name to BeOne Medicines Ltd., announced it will change its Nasdaq ticker symbol to "ONC" on January 2, 2025,
1y agoBGNEBeiGene Announces Global Licensing Agreement for MAT2A InhibitorBusiness WireBeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160, SSE: 688235)), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced it has entered into a global licensing agreement with CSPC
1y agoBGNEBeiGene Advances Leadership in CLL at ASH 2024 with New Data From Its Hematology Franchise Including BRUKINSA® and Novel Pipeline AssetsBusiness Wire5-year follow-up from SEQUOIA study demonstrated treatment with BRUKINSA reduced the risk of progression or death by 71% compared to bendamustine-rituximab in patients with treatment-naïve CLL, further solidifying its
1y agoBGNEBeiGene and CLL Society Partner to Advance Test Before Treat™ Campaign, Promoting Biomarker Testing to Improve Patient Outcomes in CLLBusiness WireAbout 50% of patients with CLL/SLL have high-risk molecular features limiting effectiveness of certain treatments; a blood test can identify these features and help guide which therapy is most likely to be
1y agoBGNEBeiGene to Host Investor Webcast Highlighting Key Data from ASH and the San Antonio Breast Cancer Symposium on December 16, 2024Business WireBeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160, SSE: 688235)), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced it will host an investor webcast on December 16, 2024 at 8:30 am
1y agoBGNEEuropean Commission Approves BeiGene's TEVIMBRA for First-Line Treatment of Advanced/Metastatic Esophageal Squamous Cell Carcinoma and Gastric or Gastroesophageal Junction CancerBusiness WireNew indications based on two Phase 3 studies demonstrating statistically significant overall survival benefit for patients treated with TEVIMBRA in combination with chemotherapy BeiGene, Ltd. (NASDAQ:BGNE, HKEX:
1y agoBGNEBeiGene to Present at Upcoming Investor ConferencesBusiness WireBeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160, SSE: 688235)), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced it will participate in fireside chats at two upcoming investor
1y agoLH BGNELabcorp CFO Glenn Eisenberg Announces Plans to RetirePR NewswireLabcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today that Executive Vice President and Chief...
1y agoBGNEBeiGene Announces Settlement of Litigation Against Generic Filer of BRUKINSABusiness WireAgreement provides for generic entry of innovative BTK inhibitor in 2037 BeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160, SSE: 688235)), a global oncology company which intends to change its name to BeOne Medicines Ltd.,
1y agoBGNEBeiGene Unveils Proposed Name Change to BeOne Medicines, Reaffirming Its Mission to Unite Global Community Against CancerBusiness WireNew name reflects Company's bold vision to eradicate cancer by harnessing the transformative power of global collaboration and multisectoral partnerships Company will change its Nasdaq ticker to ONC BeiGene, Ltd.
1y agoBGNEBeiGene Announces Third Quarter 2024 Financial Results and Corporate UpdatesBusiness WireContinued financial progress with $1 billion in quarterly total revenue, reduced GAAP loss and second consecutive quarter of positive non-GAAP operating income Strengthened franchise leadership in chronic
2y agoBGNEBeiGene to Present at the Jefferies London Healthcare ConferenceBusiness WireBeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160, SSE: 688235)), a global oncology company, today announced it will participate in the Jefferies London Healthcare Conference on November 20, 2024, with a fireside chat at 2:30
2y agoBGNEBeiGene Highlights Innovative Hematology Portfolio Across B-cell Malignancies at ASH 2024Business WireFive-year results of Phase 3 SEQUOIA study demonstrate durable benefits of BRUKINSA in patients with CLL Two oral presentations showcase promising safety and efficacy data for BTK chimeric degradation activation
2y agoBGNEBeiGene Mourns Death of Beloved Board Member Donald GlazerBusiness WireBeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160, SSE: 688235)), a global oncology company, is saddened to share the news that Donald Glazer recently passed away. Don was a Board member and the chair of the nominating and
2y agoBGNEBeiGene Receives Positive CHMP Opinions for TEVIMBRA® as a First-Line Treatment for Advanced/Metastatic Gastric or Gastroesophageal Junction Cancer and Esophageal Squamous Cell CarcinomaBusiness WirePositive opinion for first-line treatment of gastric or gastroesophageal junction cancer based on results of RATIONALE-305 study demonstrating statistically significant overall survival benefit for TEVIMBRA in
2y agoBGNEBeiGene Highlights Waldenström's Macroglobulinemia Innovation at IWWM 2024Business WireStudies of BRUKINSA® (zanubrutinib), BTK CDAC degrader BGB-16673 and BCL2 inhibitor sonrotoclax featured in invited talks and oral presentations BeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160, SSE: 688235)), a global
2y agoONCY ABBV BGNE HCM+1FDA Approves 16 New Cancer Treatments as Global Cancer Rates SkyrocketPR NewswireUSA News Group News Commentary – While some forms of cancer are seeing death rates fall, the world is witnessing a global surge in cancers among...
2y agoBGNEBeiGene Provides Update on FDA Advisory Committee Vote on Benefit-Risk Profile of PD-1 Inhibitors, including TEVIMBRA®, for Treatment of ESCC and Gastric/GEJ CancersBusiness WireVote recommends a class-wide PD-L1 expression level cut-off across PD-1 inhibitors in advanced esophageal squamous cell carcinoma and gastric/gastroesophageal junction cancers Biologics License Applications for
2y agoBGNEGlobal Oncology Innovator BeiGene Appoints Shalini Sharp to Board of DirectorsBusiness WireBeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160, SSE: 688235)), a global oncology company, today announced the appointment of Shalini Sharp to its Board of Directors and as a member of the Board's Audit Committee, effective
2y agoBGNEBeiGene Announces Updates to Commercial Leadership TeamBusiness WireBeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160, SSE: 688235)), a global oncology company, today announced the appointment of Matt Shaulis as General Manager of North America, effective September 25. "We are excited to welcome
2y agoBGNEBeiGene to Present at the Morgan Stanley 22nd Annual Global Healthcare ConferenceBusiness WireBeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160, SSE: 688235)), a global oncology company, today announced it will participate in the Morgan Stanley 22nd Annual Global Healthcare Conference on September 5, 2024, with a fireside
2y agoBGNEBeiGene's BGB-16673 Receives U.S. FDA Fast Track Designation for CLL/SLLBusiness WireDesignation supported by promising safety and efficacy data from Phase 1/2 study in heavily pretreated patients with relapsed/refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma
2y agoBGNEBeiGene Enters Next Phase of Global Growth with Announcement of Second Quarter 2024 Financial Results and Corporate UpdatesBusiness WireGenerated total revenues of $929 million, an increase of 56% from the prior-year period; reduced GAAP operating loss and achieved non-GAAP operating income Strengthened hematology leadership with global BRUKINSA
2y agoBGNEBeiGene Opens Flagship U.S. Biologics Manufacturing and Clinical R&D Facility, Continues Global Expansion to Deliver Medicines to More Patients Around the WorldBusiness Wire$800 million investment in New Jersey supports global growth and expansion with technologically advanced manufacturing capacity and clinical development capabilities for novel cancer medicines BeiGene, Ltd.
2y agoBGNEBeiGene to Present New Data from SEQUOIA Study Evaluating BRUKINSA® plus Venetoclax in High-Risk First-Line CLL/SLL at EHA2024Business WireArm D of SEQUOIA study evaluated treatment-naïve patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma with del(17p) and/or TP53 mutation Preliminary data suggest promising efficacy and
2y agoBGNEBeiGene to Present at the Goldman Sachs 45th Annual Global Healthcare ConferenceBusiness WireBeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160, SSE: 688235)), a global oncology company, today announced the Company will participate in the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024
2y agoBGNEApproval of Brukinsa, Nda #213217 (Labeling)FDA Approved DrugsApproval Date: 06/04/2024; Drug Name: Brukinsa, Nda #213217; Active Ingredients: ZANUBRUTINIB; Company: Beigene; Submission Status: Approval; Submission Classification: Labeling; Application Number: 213217
2y agoBCTX BCTXW BGNEBriaCell Announces Clinical Supply Agreement with BeiGene for Bria-OTS™ First in Human StudyGlobeNewswireStudy to evaluate the effects of Bria-OTS™ in combination with anti-PD-1 antibody tislelizumab, in advanced, late stage, heavily pretreated metastatic breast cancer. PHILADELPHIA and VANCOUVER, British
2y agoBGNEBRUKINSA® Data at ASCO Underscore Differentiated Clinical Profile for Treatment of CLL and SLLBusiness WireNew network meta-analysis demonstrates favorable progression-free survival for patients treated with BRUKINSA vs other BTKi's Analysis of Kaiser Permanente database shows BRUKINSA effective and generally well
2y agoBGNEBeiGene Highlights New Hematology Portfolio and Pipeline Data at EHA2024Business WireStudy evaluating BRUKINSA® in combination with venetoclax in high-risk, treatment-naïve CLL/SLL patients to be shared as oral presentation BCL2 inhibitor sonrotoclax subject of multiple presentations highlighting
2y agoBGNEBeiGene Reports First Quarter 2024 Financial Results and Business UpdatesBusiness WireTotal revenues of $752 million in the first quarter, including product revenue of $747 million, an 82% increase from the prior-year period BRUKINSA revenue of $489 million, driven by growth in the U.S. and Europe of
2y agoBGNEBeiGene Demonstrates Global Progress in 2023 Responsible Business & Sustainability ReportBusiness WireNewly released report details Company's achievements and plans for sustainable growth BeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160, SSE: 688235)), a global oncology company, released its 2023 Responsible Business &
2y agoBGNEGlobal Oncology Innovator BeiGene Highlights New Data across Hematology and Solid Tumor Portfolio at 2024 ASCO Annual MeetingBusiness WireMultiple presentations to showcase the efficacy and safety of BRUKINSA® across a range of B-cell malignancies Company to present three-year data from RATIONALE-306 study of TEVIMBRA® in advanced or
2y agoBGNEBeiGene Receives European Commission Approval for Tislelizumab as Treatment for Non-Small Cell Lung CancerBusiness WireComprehensive development program, including three Phase 3 clinical trials, demonstrated benefit of tislelizumab for patients with treatment-naïve and relapsed NSCLC Decision represents tislelizumab's second approval
2y agoBGNEBeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior ChemotherapyBusiness WireResults from the global, Phase 3 RATIONALE 302 trial showed TEVIMBRA prolonged the survival of patients who received prior systemic treatment compared to chemotherapy Approval represents the first indication in the
2y agoBGNEPi Health Raises Over $30M in Series A to Revolutionize Cancer Care and Clinical TrialsBusiness WireLooks to enable patients all over the world to have equal access to the highest quality of cancer care and research Pi Health, an oncology-focused health technology and clinical research company committed to
2y agoBGNEFirst Doses of BRUKINSA® provided to Patients with Chronic Lymphocytic Leukemia in Low- and Middle-Income Countries Under Collaboration of The Max Foundation, BeiGene, and the BeiGene FoundationBusiness WireArmenia and Nepal are the first of 29 countries to receive BRUKINSA The Max Foundation (Max), a global nonprofit organization dedicated to accelerating health equity by delivering medication, technology, and
2y agoBGNEBeiGene Announces FDA Accelerated Approval of BRUKINSA for the Treatment of Relapsed or Refractory Follicular LymphomaBusiness WireBRUKINSA is the first and only BTK inhibitor approved across five oncology indications and the first and only approved in follicular lymphoma Approval based on positive results from ROSEWOOD trial showing BRUKINSA
2y agoBGNEApproval of Brukinsa, Nda #213217 (Efficacy)FDA Approved DrugsApproval Date: 03/07/2024; Drug Name: Brukinsa, Nda #213217; Active Ingredients: ZANUBRUTINIB; Company: Beigene; Submission Status: Approval; Submission Classification: Efficacy; Application Number: 213217
2y agoBGNEBeiGene to Present Clinical and Preclinical Data from Broad Portfolio and Pipeline at AACR Annual Meeting 2024Business WireMultiple trials underscore the potential of tislelizumab-containing immuno-oncology combinations in a variety of solid tumor settings Additional highlights include preclinical characterization data for an
2y agoBGNEBeiGene Announces New Efficacy Analysis Comparing BRUKINSA® vs Acalabrutinib in Relapsed or Refractory Chronic Lymphocytic LeukemiaBusiness WireMatching adjusted indirect comparison addresses key questions and limitations associated with previously presented analysis and suggests efficacy advantage of BRUKINSA vs acalabrutinib BeiGene, Ltd. (NASDAQ:BGNE,
2y agoBGNEBeiGene to Present at Upcoming Investor ConferencesBusiness WireBeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160, SSE: 688235)), a global oncology company, today announced that the Company will participate in fireside chats at two upcoming investor conferences: TD Cowen 44th Annual Health
2y agoBGNEBeiGene's Biologics License Application for TEVIMBRA® (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDABusiness WireApplication based on results from global Phase 3 RATIONALE-305 trial demonstrating TEVIMBRA plus chemotherapy significantly improved overall survival in advanced gastric/GEJ cancer Prescription Drug User Fee Act
2y agoBGNEBeiGene Reports Fourth Quarter and Full Year 2023 Financial Results and Business UpdatesBusiness WireContinued rapid global growth with record total revenues of $634 million in fourth quarter and $2.5 billion in full-year 2023, increases of 67% and 74% from the prior-year periods Strengthened leadership in
2y agoBGNEBeiGene Receives Positive CHMP Opinion for Tislelizumab as Treatment for Non-Small Cell Lung CancerBusiness WireRecommendation based on results of three Phase 3 clinical trials demonstrating benefit of tislelizumab as a first- and second-line treatment for patients with NSCLC BeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160, SSE:
2y agoBGNEA Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors - NCT06257264ClinicalTrials.govPart 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Part 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-68501, Part 1: Recommended dose(s) for Expansion (RDFE) of BG-68501 in participants with solid tumors, (and 13 more...)