Welcome to our dedicated page for BeOne Medicines Ltd. news (Ticker: ONC), a resource for investors and traders seeking the latest updates and insights on BeOne Medicines Ltd. stock.
BeOne Medicines Ltd. (ONC) generates a steady flow of oncology news that reflects its focus on hematology and solid tumors. As a Switzerland‑domiciled global oncology company with listings on NASDAQ, the Hong Kong Stock Exchange and the STAR Market in Shanghai, BeOne regularly issues updates on clinical data, regulatory milestones, financial performance and corporate developments.
Investors and healthcare professionals following ONC news will see frequent announcements related to B‑cell malignancies, especially chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). The company highlights new data for its BTK inhibitor BRUKINSA, including long‑term results from Phase 3 trials such as SEQUOIA and ALPINE, as well as patient‑reported outcomes and guideline updates. News also covers sonrotoclax, an investigational BCL2 inhibitor, with items on FDA Breakthrough Therapy Designation, Priority Review for relapsed or refractory MCL, and clinical results in CLL and other B‑cell cancers. Updates on BTK degrader BGB‑16673 from the CaDAnCe clinical program appear alongside these hematology releases.
On the solid tumor side, BeOne’s news includes Phase 3 trial results for ZIIHERA (zanidatamab) plus TEVIMBRA (tislelizumab) and chemotherapy in first‑line HER2‑positive gastroesophageal adenocarcinoma, as well as regulatory plans based on these data. Additional releases describe TEVIMBRA’s expanding indications and BGB‑B2033’s FDA Fast Track Designation in hepatocellular carcinoma. Financial news items provide quarterly revenue, product sales trends for BRUKINSA and TEVIMBRA, cash flow metrics and updated guidance, while corporate updates cover conference presentations, research milestones and agreements such as the IMDELLTRA royalty purchase arrangement with Royalty Pharma.
For users tracking ONC, this news stream offers insight into BeOne’s evolving hematology and solid tumor portfolios, its regulatory interactions in major markets and its stated goal of broadening patient access to cancer therapies. Bookmarking the ONC news page on Stock Titan allows readers to follow company press releases, clinical milestones and financial disclosures in one place.
BeOne Medicines (Nasdaq: ONC) has received European Commission approval for a new film-coated tablet formulation of BRUKINSA® (zanubrutinib) across all approved indications. The new tablet version offers significant improvements in treatment administration, reducing the daily pill burden from four to two pills while maintaining the recommended 320mg daily dose.
The 160mg tablets feature a smaller size and film coating for easier swallowing, enhancing patient convenience. This development comes as BRUKINSA maintains its position as the BTK inhibitor with the broadest label in Europe, having treated more than 200,000 patients globally.
BeOne Medicines (NASDAQ: ONC) reported strong Q2 2025 financial results with total revenues increasing 42% to $1.3 billion compared to Q2 2024. The company's flagship product BRUKINSA achieved 49% growth to $950 million in global revenues. BeOne reported GAAP diluted EPS of $0.84 and non-GAAP diluted EPS of $2.25 per ADS.
The company updated its FY2025 revenue guidance to $5.0-$5.3 billion and maintained operating expense guidance. BeOne's strong performance was driven by BRUKINSA's U.S. market leadership and global expansion, with U.S. sales reaching $684 million (43% growth) and European sales hitting $150 million (85% growth). The company anticipates over 20 R&D milestones in the next 18 months across its hematology and solid tumor pipeline.
Gross margin improved to 87.4% from 85.0% year-over-year, while free cash flow reached $220 million, a significant improvement from -$206 million in Q2 2024.
BeOne Medicines (NASDAQ: ONC) has achieved a significant regulatory milestone as the European Medicines Agency (EMA) granted PRIME designation to BGB-16673, their investigational BTK degrader for treating Waldenstrom's macroglobulinemia patients previously treated with BTK inhibitors.
The company received additional regulatory support, including a positive CHMP opinion on EU Orphan Drug Designation and FDA Fast Track Designation for BGB-16673 in multiple B-cell malignancies. The PRIME designation, BeOne's first, was granted based on the drug's novel mechanism and promising anti-tumor activity data, potentially accelerating its path to marketing authorization.
BeOne Medicines (NASDAQ: ONC) received a positive CHMP opinion recommending approval of TEVIMBRA® for neoadjuvant/adjuvant treatment of resectable non-small cell lung cancer (NSCLC). The recommendation is based on the Phase 3 RATIONALE-315 study, which demonstrated significant clinical benefits.
Key results from the study include a 56.2% major pathologic response rate for TEVIMBRA plus chemotherapy versus 15.0% for placebo, and a 40.7% pathological complete response rate compared to 5.7% for placebo. The study also showed statistically significant event-free survival benefits (HR: 0.56) and a positive trend in overall survival (HR: 0.62).
The safety profile remained consistent with previous studies, with 72.1% of patients experiencing grade ≥3 treatment-related adverse events in the TEVIMBRA arm versus 66.4% in the placebo arm.
BeOne Medicines (NASDAQ: ONC), a global oncology company, has scheduled its second quarter 2025 financial results announcement for Wednesday, August 6, 2025, before market open. The company will host a live management webcast at 8:00 a.m. ET following the financial release.
Investors can access the webcast through BeOne's investor relations websites. Participants are advised to register 15 minutes before the scheduled start time. An archived version of the webcast will be available for later viewing.
BeOne Medicines (NASDAQ: ONC) has received European Commission approval for TEVIMBRA® (tislelizumab) in combination with gemcitabine and cisplatin for first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC). The approval is based on the RATIONALE-309 Phase 3 study results, which showed significant improvements in patient outcomes.
The study demonstrated a 48% reduction in disease progression or death risk, with median progression-free survival of 9.2 months for TEVIMBRA plus chemotherapy versus 7.4 months for placebo. Overall survival improved to 45.3 months compared to 31.8 months with placebo. This marks TEVIMBRA's second EU approval in 2025, adding to its existing approvals across various cancer indications.
BeOne Medicines (NASDAQ: ONC) showcased its extensive oncology pipeline during its R&D Day, highlighting significant advancements across multiple therapeutic areas. The company's portfolio includes over 40 clinical and commercial-stage assets, with 20 near-term milestones expected in the next 18 months.
Key highlights include new data from their hematologic cancer program, featuring BRUKINSA® (zanubrutinib), sonrotoclax, and BGB-16673 (BTK CDAC). In solid tumors, BeOne presented promising developments in their CDK4 inhibitor BGB-43395 for breast cancer, B7-H4 ADC for B7-H4 expressing tumors, and a novel PRMT5 inhibitor for lung cancer.
The company's global clinical development platform spans 170+ trials across 40 countries with over 25,000 patients enrolled, supported by in-house manufacturing facilities including their flagship in Hopewell, NJ.
BeOne Medicines (NASDAQ: ONC) received a positive CHMP opinion recommending approval for a new film-coated tablet formulation of BRUKINSA® (zanubrutinib) for all approved indications in Europe. The new 160 mg tablet formulation is bioequivalent to existing capsules and reduces daily pill intake from four to two tablets while maintaining the 320 mg daily dosage.
The tablet version offers several advantages including easier swallowing, flexible dosing options, and environmental benefits through 70% smaller bottle size and reduced temperature control requirements during shipping. This follows recent FDA approval of the tablet formulation, where BRUKINSA leads in new patient starts for chronic lymphocytic leukemia and overall BTK inhibitor market share.