$ONC News

Last published 6d ago

6d agoONCBeOne Medicines Ltd. - EX-99.1Earnings ReleasesForm 8-K - Current report - Item 2.02 Item 9.01
2w agoONCBeOne Presents Compelling Data in Hard-to-Treat Liver and Lung Cancers at ESMO 2026Business WirePotential first-in-class GPC3 x 4-1BB bispecific achieves a 36% confirmed response rate at Phase 3 dose and favorable safety profile in heavily pretreated liver cancer Brain-penetrant PRMT5 inhibitor shows promising
2w agoONCBeOne Medicines Reports Sustained Survival Benefit with TEVIMBRA-ZIIHERA Combination in First-Line HER2+ Gastroesophageal CancerBusiness WireNew data from HERIZON-GEA-01 Phase 3 trial show 36-month overall survival of nearly 40% with TEVIMBRA plus ZIIHERA and chemotherapy, and median OS reaching 27 months TEVIMBRA-containing arm was associated with a
2w agoONCBeOne Medicines to Announce Third Quarter 2026 Financial Results on November 5Business WireBeOne Medicines Ltd. (NASDAQ:ONC, HKEX: 06160, SSE: 688235)), a global oncology company, will report its third quarter 2026 financial results on Thursday, November 5, 2026, before the financial markets open. Following
3w agoONCBeOne Medicines Highlights Rapidly Accelerating Solid Tumor Franchise at ESMO 2026Business WireNew data from four priority programs, including the GPC3x4-1BB bispecific antibody, CEA targeting ADC, CDK4 inhibitor, and brain-penetrant PRMT5 inhibitor underscore the depth of BeOne’s solid tumor pipeline Multiple
1mo agoONCMorgan Stanley 24th Annual Global Healthcare Conference - BEONE MEDICINES LTDEarnings Call TranscriptsGood morning, everyone. I'm Sean Laman, Head of US Mid-Cap Equity Research, Biotech Equity Research here at Morgan Stanley, and welcome to our Global Healthcare Conference. Before we begin, for important disclosures, ple
2mo agoONCBeOne Medicines to Present at the Morgan Stanley Annual Global Healthcare ConferenceBusiness WireBeOne Medicines Ltd. (NASDAQ:ONC, HKEX: 06160, SSE: 688235)), a global oncology company, today announced it will participate in the Morgan Stanley Annual Global Healthcare Conference on September 14, 2026, with a
2mo agoONCBeOne Medicines Announces Voluntary Agreement with U.S. Government to Expand Access to Innovative Cancer MedicinesBusiness WireAgreement advances patient access and strengthens BeOne's long-term commitment to U.S. innovation and manufacturing BeOne Medicines, Ltd. (NASDAQ:ONC, HKEX: 06160, SSE: 688235)), a global oncology company, today
2mo agoONCBeOne Medicines Announces New Phase 3 Survival Data Reinforcing Benefit of ZIIHERA-Containing Regimens in First-Line HER2+ Gastroesophageal CancerBusiness WireFindings provide further evidence of overall survival benefit of TEVIMBRA plus ZIIHERA and chemotherapy regimen in HER2+ GEA ZIIHERA plus chemotherapy demonstrated statistically significant overall survival benefit
2mo agoONCBeOne Medicines Announces U.S. FDA Approval for TEVIMBRA-Based Regimen for First-Line HER2+ GEABusiness WireTEVIMBRA plus ZIIHERA and chemotherapy is the first and only immunotherapy-based regimen to deliver more than two years of median OS in first-line HER2+ GEA, regardless of PD-L1 status Regimen poised to become
2mo agoONCBeOne Medicines, BeOne Care Foundation, and The Max Foundation Renew Partnership to Expand Access to BRUKINSA® for the Treatment of Chronic Lymphocytic Leukemia in Low- and Middle-Income CountriesBusiness WireRenewed collaboration builds on access provided to more than 300 patients with CLL to date and plans to support approximately 1,000 patients through 2028 BeOne Medicines Ltd. ("BeOne") (NASDAQ:ONC, HKEX:
3mo agoONC RVMDBeOne Medicines and Revolution Medicines Announce Clinical Development and Regional Commercialization CollaborationBusiness WireClinical collaboration enables novel combinations of select BeOne oncology assets with four Revolution Medicines clinical-stage RAS(ON) inhibitors for RAS-addicted cancers Regional rights agreement provides BeOne
3mo agoONCBeOne Medicines Announces Second Quarter 2026 Financial Results and Business UpdatesBusiness WireTotal global revenues of $1.7 billion for the second quarter, an increase of 30% from the prior year BRUKINSA (zanubrutinib) global revenues of $1.2 billion for the second quarter, an increase of 31% from the
3mo agoONCBeOne Medicines Expands U.S. Manufacturing with Total Investment of More Than $1 Billion to Advance Innovative Cancer MedicinesBusiness Wire$300 million expansion of flagship manufacturing facility in Hopewell, New Jersey, adds small molecule manufacturing capacity, enhancing U.S. domestic production capabilities Creates 120 new full-time jobs to support
3mo agoONCBeOne Medicines to Announce Second Quarter 2026 Financial Results on August 5Business WireBeOne Medicines Ltd. (NASDAQ:ONC, HKEX: 06160, SSE: 688235)), a global oncology company, will report its second quarter 2026 financial results on Wednesday, August 5, 2026 before the financial markets open. Following
4mo agoONCBeOne Medicines Announces Positive Phase 3 Results for BRUKINSA in Frontline Mantle Cell LymphomaBusiness WireFoundational BTKi BRUKINSA plus rituximab reduced the risk of progression or death by 43% versus bendamustine plus rituximab (HR=0.57; p<0.0001), meeting the primary endpoint of PFS MANGROVE is the first Phase 3
5mo agoONCBeOne Medicines' Foundational Hematology Franchise Leads Next Era of B-Cell Cancer Innovation at EHA 2026Business WireTacabrutideg (BGB-16673, BTK degrader) showed durable responses in heavily pretreated R/R CLL and BTK inhibitor–naïve patients, signaling potential for earlier lines of treatment BRUKINSA plus sonrotoclax (ZS)
5mo agoONCBeOne Showcases Landmark Phase 3 Data in CLL Patients Aged 80+ at EHA 2026, Reinforcing BRUKINSA BenefitBusiness WireNearly two-thirds of patients aged 80+ treated with BRUKINSA remained progression-free at six years, despite advanced age and high-risk features New European patient research reveals safety, disease severity, and
5mo agoONCGoldman Sachs 47th Annual Global Healthcare Conference - BeOne MedicinesEarnings Call TranscriptsAll right. Thank you, everyone, for joining this session. My name is Ling Haizhang. I'm the China Biotech Analyst. Today, with great privilege, we have the opportunity to host the management from B1 Medicines. On the fur
5mo agoONCBeOne Medicines Highlights Accelerating Solid Tumor Pipeline with New Data at ASCO 2026Business WireOral and poster presentations span three priority programs in breast, gynecologic, and gastrointestinal cancers, advancing rapidly toward pivotal development Company to host investor webcast showcasing momentum across
5mo agoONCBeOne Medicines Establishes Standard for Long-Term Disease Control in CLL with BRUKINSA 78-Month Data at ASCO 2026Business WireData represents the longest reported follow-up for a next-generation BTK inhibitor in CLL, showing sustained disease control and benefit that extends beyond first-line therapy BRUKINSA plus next-generation BCL2
5mo agoONCBeOne Medicines Announces Phase 3 HERIZON-GEA Data Published in NEJM and Presented at ASCO 2026Business WireTEVIMBRA plus ZIIHERA and chemotherapy demonstrated statistically significant overall survival benefit with an unprecedented seven-month improvement in first-line HER2+ GEA Oral presentation at ASCO highlights benefit
5mo agoONCBeOne Medicines to Present at the Goldman Sachs 47th Annual Global Healthcare ConferenceBusiness WireBeOne Medicines Ltd. (NASDAQ:ONC, HKEX: 06160, SSE: 688235)), a global oncology company, today announced it will participate in the Goldman Sachs 47th Annual Global Healthcare Conference on June 8, 2026, with a fireside
5mo agoONCBeOne Medicines Sets the Pace in Oncology at ASCO and EHA 2026 with 60+ AbstractsBusiness WireLong-term and real-world evidence reinforce BRUKINSA as the foundation of CLL treatment Three oral presentations at ASCO highlight rapid acceleration of BeOne's solid tumor pipeline BeOne Medicines Ltd. (NASDAQ:ONC,
5mo agoONCBeOne Medicines Launches One Save Changes Everything, a Global Cancer Care Awareness Campaign with Soccer Legend Tim HowardBusiness WireCampaign connects the preparation, precision, and grit that define great goalkeeping to the persistent scientific, clinical, and community efforts that drive progress in cancer care Features international goalkeepers,
6mo agoONCBeOne Medicines' BEQALZI™ (sonrotoclax) Approved by U.S. FDA as First and Only BCL2 Inhibitor for R/R Mantle Cell LymphomaBusiness WireBEQALZI is a foundational BCL2 inhibitor designed for greater potency and selectivity, with potential to improve efficacy, tolerability, and convenience versus others in the class Approval of BEQALZI marks the first
6mo agoONCBEONE Q1 2026 EARNINGS CALL WEBCASTBEONE MEDICINES LTDEarnings Call TranscriptsGood day, everyone. Welcome to B1 Medicine's Q1 2026 earnings call webcast. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. At
6mo agoONCBEONE Q1 2026 EARNINGS CALL WEBCAST - BEONE MEDICINES LTDEarnings Call TranscriptsGood day, everyone. Welcome to B1 Medicine's Q1 2026 earnings call webcast. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. At
6mo agoONCBeOne Medicines Announces First Quarter 2026 Financial Results and Business UpdatesBusiness WireTotal global revenues of $1.5 billion for the first quarter, an increase of 35% from the prior year Foundational BRUKINSA (zanubrutinib) global revenues of $1.1 billion for the first quarter, an increase of 38%
6mo agoONCU.S. FDA Grants Priority Review to BeOne Medicines' TEVIMBRA in First-Line HER2+ GEABusiness WireTEVIMBRA plus ZIIHERA and chemotherapy regimen delivered statistically significant median OS of 26.4 months, an unprecedented result in this challenging disease Results from the global Phase 3 HERIZON-GEA-01 study
6mo agoONCBeOne Medicines to Announce First Quarter 2026 Financial Results on May 6Business WireBeOne Medicines Ltd. (NASDAQ:ONC, HKEX: 06160, SSE: 688235)), a global oncology company, will report its first quarter 2026 financial results on Wednesday, May 6, 2026 before the financial markets open. Following the
8mo agoONCBeOne Medicines Announces Fourth Quarter and Full Year 2025 Financial Results, Highlighting Global Success of BRUKINSA and Foundational Oncology LeadershipBusiness WireTotal global revenues of $1.5 billion and $5.3 billion for the fourth quarter and full year, increases of 33% and 40% from the prior-year periods Global BRUKINSA (zanubrutinib) revenues of $1.1 billion and $3.9
8mo agoONCBeOne Medicines to Present at Upcoming Investor ConferencesBusiness WireBeOne Medicines Ltd. (NASDAQ:ONC, HKEX: 06160, SSE: 688235)), a global oncology company, today announced that the Company will participate in fireside chats at four upcoming investor conferences: TD Cowen 46th Annual
9mo agoONCBeOne Medicines to Announce Fourth Quarter and Full Year 2025 Financial Results on February 26Business WireBeOne Medicines Ltd. (NASDAQ:ONC, HKEX: 06160, SSE: 688235)), a global oncology company, will report its fourth quarter and full year 2025 financial results on Thursday, February 26, 2026 before the financial markets
10mo agoONCBeOne Medicines to Present at the 44th Annual J.P. Morgan Healthcare ConferenceBusiness WireBeOne Medicines Ltd. (NASDAQ:ONC, HKEX: 06160, SSE: 688235)), a global oncology company, today announced it will participate in the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, with a
10mo agoONCBeOne Medicines Granted U.S. FDA Fast Track Designation for BGB-B2033 as Treatment for Hepatocellular CarcinomaBusiness WireBGB-B2033 is a bispecific antibody directed at GPC3 and 4-1BB; key targets in the most common liver cancer FDA Fast Track Designation reflects the potential of BGB-B2033 in an area of high unmet need BeOne Medicines
11mo agoONCBRUKINSA Delivers Landmark 74% 6-Year PFS in Patients with Treatment-Naïve Chronic Lymphocytic LeukemiaBusiness WireMultiple long-term follow-up studies confirm BRUKINSA's superior efficacy and favorable tolerability versus ibrutinib in relapsed or refractory CLL Additional ASH data from investigational BTK degrader, BGB-16673,
11mo agoONCSonrotoclax Data at ASH 2025 Confirm Foundational Potential Across B-cell MalignanciesBusiness WireNovel BCL2 inhibitor sonrotoclax monotherapy demonstrates deep and durable clinical responses in R/R MCL and R/R CLL Sonrotoclax in combination with BRUKINSA demonstrated rapid MRD negativity in treatment-naive CLL,
11mo agoONCU.S. FDA Grants Priority Review to Sonrotoclax for the Treatment of Relapsed or Refractory Mantle Cell LymphomaBusiness WireIf approved, sonrotoclax will become the first BCL2 inhibitor for R/R MCL in the U.S., addressing a high unmet need in an aggressive cancer Sonrotoclax previously received Breakthrough Therapy Designation based on
11mo agoONCBeOne Medicines Showcases Leadership in B-cell Malignancies at ASH 2025Business WireBRUKINSA now demonstrates best-in-class sustained efficacy and long-term benefit with a favorable safety profile over more than six years of follow-up data in treatment-naïve and R/R CLL First results from Phase 1/2
11mo agoONCPositive Phase 3 Results Support ZIIHERA® as HER2-Targeted Therapy-of-Choice and Combination with TEVIMBRA® and Chemotherapy as New Standard of Care in First-Line HER2-Positive Locally Advanced or Metastatic Gastroesophageal AdenocarcinomaBusiness WireZIIHERA plus TEVIMBRA and chemotherapy demonstrated clinically meaningful and statistically significant improvements in PFS and OS versus trastuzumab and chemotherapy ZIIHERA plus chemotherapy showed a clinically
1y agoONCBeOne Medicines Announces Third Quarter 2025 Financial Results and Business UpdatesBusiness WireThird quarter total revenues increased 41% to $1.4 billion versus third quarter 2024 Global BRUKINSA® (zanubrutinib) revenues increased 51% to $1.0 billion versus third quarter 2024 Diluted GAAP Earnings per
1y agoONCBeOne Medicines to Present at Upcoming Investor ConferencesBusiness WireBeOne Medicines Ltd. (NASDAQ:ONC, HKEX: 06160, SSE: 688235)), a global oncology company, today announced it will participate in fireside chats at two upcoming investor conferences: Guggenheim Second Annual Healthcare
1y agoONCBeOne Medicines to Announce Third Quarter 2025 Financial Results on November 6Business WireBeOne Medicines Ltd. (NASDAQ:ONC, HKEX: 06160, SSE: 688235)), a global oncology company, will report its third quarter 2025 financial results on Thursday, November 6, 2025 before the financial markets open. Following
1y agoONC ZLAB CRVS DNA+2The Institute for Follicular Lymphoma Innovation (IFLI) Appoints Innovative Leaders Mehrdad Mobasher, M.D., M.P.H., and Carol O'Hear, M.D., Ph.D., as Executive PartnersPR NewswireThe Institute for Follicular Lymphoma Innovation (IFLI), a global, non-profit, private foundation dedicated to accelerating the development of...
1y agoONCBeOne Medicines Presents New Data on TEVIMBRA in Lung Cancer at ESMO 2025Business WireNew data from two pivotal TEVIMBRA studies – RATIONALE-307 and -312 – reinforce the PD-1 inhibitor's proven clinical benefit in both NSCLC and ES-SCLC Early data from investigational HPK1 inhibitor BGB-26808, in
1y agoONCBeOne Medicines' Sonrotoclax Granted Breakthrough Therapy Designation by U.S. FDABusiness WireBreakthrough designation based on early, positive results of a Phase 1/2 study of sonrotoclax in patients with relapsed or refractory mantle cell lymphoma (MCL) BeOne to participate in Project Orbis program,
1y agoONCBeOne Medicines AG (ONC) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference (Transcript)Earnings Call Transcripts
1y agoONCBeOne Medicines Announces Positive Topline Results for Sonrotoclax in Relapsed or Refractory Mantle Cell Lymphoma (MCL)Business WireStudy met its primary endpoint of overall response rate (ORR), demonstrating clinically meaningful responses in rare B-cell lymphoma with high unmet need BeOne to submit data to global regulatory authorities for their
1y agoONCEuropean Commission Approves TEVIMBRA® as Neoadjuvant/Adjuvant NSCLC Treatment Ahead of Late-Breaking Data Presentation at WCLC 2025Business WireFinal analysis of RATIONALE-315 demonstrates clear overall survival benefit in perioperative setting in resectable non-small cell lung cancer Broad EU label with nine approved indications in solid tumors, including