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.
BeiGene Ltd (NASDAQ: BGNE) is a global biotechnology leader pioneering innovative oncology therapies through its integrated research and clinical trial model. This page serves as the definitive source for verified company developments, offering stakeholders timely access to essential updates.
Find comprehensive coverage of BeiGene's progress in cancer treatment innovation, including clinical trial milestones, regulatory submissions, and strategic collaborations. The curated news collection enables efficient tracking of the company's pipeline advancements in checkpoint inhibitors and targeted small molecule therapies.
Key updates include quarterly financial results, manufacturing expansions, and peer-reviewed research publications. All content undergoes rigorous verification to ensure accuracy in reporting scientific developments and corporate announcements.
Bookmark this page for direct access to BeiGene's latest press releases and analysis of their unique CRO-free clinical development approach, a strategic differentiator in global biopharmaceutical operations.
BeiGene (NASDAQ: ONC) received a positive CHMP opinion recommending approval of TEVIMBRA® (tislelizumab) in combination with etoposide and platinum chemotherapy for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).
The recommendation is based on the RATIONALE-312 Phase 3 study results, which demonstrated significant survival benefits. The study of 457 patients showed median overall survival of 15.5 months for TEVIMBRA with chemotherapy versus 13.5 months for placebo plus chemotherapy, representing a 25% reduction in death risk (HR 0.75).
TEVIMBRA is already approved in the EU for multiple indications including esophageal squamous cell carcinoma (ESCC), gastric/gastroesophageal junction adenocarcinoma, and non-small lung cancer. The drug has received 58 regulatory approvals in 18 months and is being studied in combination with other molecules.
BeiGene (NASDAQ: BGNE) announced FDA approval for TEVIMBRA® (tislelizumab-jsgr) in combination with chemotherapy for first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults with PD-L1 expressing tumors (≥1). The approval is based on the RATIONALE-305 Phase 3 trial results, which showed significant improvement in overall survival with TEVIMBRA plus chemotherapy (15.0 months) compared to placebo plus chemotherapy (12.9 months), representing a 20% reduction in death risk.
This marks TEVIMBRA's second FDA approval in 2024, with the drug already approved as monotherapy for esophageal squamous cell carcinoma (ESCC). An additional BLA is under review for first-line ESCC treatment.
BeiGene (NASDAQ: BGNE) announced it will change its Nasdaq ticker symbol to 'ONC' on January 2, 2025, alongside its planned name change to BeOne Medicines The new ticker reflects the company's focus on oncology and its 15-year commitment to delivering cancer medicines globally. The CUSIP number and stock codes on Hong Kong and Shanghai exchanges will remain unchanged. Additionally, the company will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025, at 1:30 pm PT, with a webcast available on their investor relations websites.
BeiGene (NASDAQ: BGNE) has entered into a global licensing agreement with CSPC for SYH2039, a novel MAT2A-inhibitor targeting solid tumors with MTAP deletion mutation. This mutation occurs in approximately 15% of all cancer types, particularly in glioblastoma, pancreatic cancer, and non-small cell lung cancer.
Under the agreement, BeiGene gains exclusive worldwide rights to develop, manufacture, and commercialize SYH2039. CSPC will receive $150 million in upfront and time-based payments, plus potential milestone payments and tiered royalties. BeiGene plans to explore SYH2039's potential in combination with their PRMT5 inhibitor, BGB-58067, which is expected to enter clinical trials by year-end.
BeiGene (NASDAQ: BGNE) presented new clinical data at ASH 2024, highlighting significant achievements in chronic lymphocytic leukemia (CLL) treatment. The 5-year SEQUOIA study showed BRUKINSA reduced progression/death risk by 71% compared to bendamustine-rituximab in treatment-naïve CLL patients.
Key findings include promising results from sonrotoclax combined with BRUKINSA, showing no progression in treatment-naïve CLL patients at 1.5 years median follow-up, with a 99% overall response rate and 92% best uMRD rate. The BTK degrader BGB-16673 demonstrated potential in treatment-resistant CLL, achieving a 94% overall response rate at 200mg dose.
BRUKINSA's safety profile remained consistent with previous studies, with notable efficacy in patients with unmutated IGHV, reducing progression/death risk by 79%.
BeiGene (NASDAQ: BGNE) has partnered with CLL Society to launch the Test Before Treat™ campaign, focusing on promoting biomarker testing for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) patients. The initiative emphasizes the importance of testing before initial treatment and retesting at subsequent treatments to ensure optimal therapy selection.
About 50% of CLL/SLL patients have high-risk molecular features that may limit treatment effectiveness. Approximately 10% have high-risk del(17p) and/or TP53 mutation before starting treatment, while 40% develop these mutations after relapsing. The campaign highlights that genetic profiles can change over time and promotes blood testing to identify mutations for better treatment guidance.
BeiGene (NASDAQ: BGNE) has announced an upcoming investor webcast scheduled for December 16, 2024 at 8:30 am EST. The company's R&D leadership team will present updates on their innovative portfolio and pipeline, specifically highlighting key presentations from the American Society of Hematology Meeting (ASH) and the San Antonio Breast Cancer Symposium. The webcast will be accessible through BeiGene's investor relations websites, with a replay available for 90 days after the event. The company also noted its intended name change to BeOne Medicines.
BeiGene's TEVIMBRA received European Commission approval for first-line treatment of advanced esophageal squamous cell carcinoma (ESCC) and gastric/gastroesophageal junction cancer in combination with chemotherapy. The approval is based on two Phase 3 studies showing significant survival benefits. In the RATIONALE-306 study for ESCC, median overall survival was 17.2 months for TEVIMBRA with chemotherapy versus 10.6 months for placebo. In the RATIONALE-305 study for G/GEJ cancer, median overall survival was 15.0 months for TEVIMBRA combination versus 12.9 months for placebo, showing a 20% reduction in death risk.
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company planning to rebrand as BeOne Medicines, has announced its participation in two upcoming investor conferences. The company will engage in fireside chats at the Citizens JMP Hematology and Oncology Summit on December 2 at 1:00 p.m. ET and Citi's Global Healthcare Conference on December 5 at 9:30 a.m. ET. Live webcasts will be available on BeiGene's investor relations websites, with recordings accessible for 90 days after the events.
Labcorp (NYSE: LH) announced that Executive Vice President and CFO Glenn Eisenberg will retire, with Julia Wang appointed as the new CFO effective December 2, 2024. Eisenberg will remain as Special Advisor to the CEO through April 2025. During Eisenberg's 10-year tenure, Labcorp doubled its revenues, completed approximately 100 acquisitions worth $11 billion, and returned over $6 billion to shareholders through repurchases and dividends. Wang joins from BeiGene, where she served as CFO and was key in driving business transformations through growth acceleration and operational efficiency.
