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) will present nearly 50 abstracts at ASH 2025 (Dec 6-9), including six orals across three hematology programs: BTK inhibitor BRUKINSA (zanubrutinib), BCL2 inhibitor sonrotoclax, and BTK degrader BGB-16673. Key disclosed metrics: SEQUOIA reports an estimated 74% PFS at 6 years in treatment‑naïve CLL/SLL and sustained overall survival of 84% (88% after COVID adjustment); ALPINE long‑term extension reports up to 6 years follow‑up. New sonrotoclax and BGB-16673 data include rapid, deep responses, uMRD findings, and multi‑malignancy activity.
BeOne Medicines (Nasdaq: ONC) reported positive top-line Phase 3 HERIZON-GEA-01 results for ZIIHERA (zanidatamab) in first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma.
Both ZIIHERA+TEVIMBRA+chemotherapy and ZIIHERA+chemotherapy showed clinically meaningful and statistically significant improvements in progression-free survival (PFS) versus trastuzumab+chemotherapy; the TEVIMBRA arm also showed a statistically significant overall survival (OS) improvement, while the ZIIHERA+chemotherapy arm showed a clinically meaningful OS effect with a strong trend toward significance at the first interim analysis.
Benefits were seen in PD-L1 positive and negative subgroups; ORR and DOR also improved. Data to be presented in Q1 2026; an additional OS interim for ZIIHERA+chemotherapy is expected mid-2026.
BeOne Medicines (NASDAQ: ONC) reported Q3 2025 total revenue $1.412B, up 41% year‑over‑year, driven by BRUKINSA and in‑licensed products. Global BRUKINSA revenue rose 51% to $1.0B; U.S. product revenue was $743M. GAAP net income was $124.8M versus a loss in Q3 2024; GAAP diluted EPS was $1.09 per ADS. Gross margin was 85.9% (GAAP); adjusted diluted EPS was $2.65 per ADS. Free cash flow was $354M. Company updated FY2025 revenue guidance to $5.1–$5.3B and reiterated mid‑to‑high‑80% gross margin guidance. Key clinical and corporate milestones include FDA Breakthrough Therapy for sonrotoclax, Phase 3 starts and a royalty sale agreement up to $950M.
BeOne Medicines (NASDAQ: ONC) will participate in two investor conference fireside chats in November 2025. The company is scheduled to present at the Guggenheim Healthcare Innovation Conference on Monday, November 10, 2025 at 9:30 am ET, and at the Jefferies Global Healthcare Conference in London on Monday, November 17, 2025 at 4:00 pm GMT / 11:00 am ET. Live webcasts and archived replays will be available from the company's investor websites in the US, Hong Kong, and Shanghai.
BeOne Medicines (NASDAQ: ONC) will report its third quarter 2025 financial results on Thursday, November 6, 2025 before U.S. markets open. Management will host a live webcast at 8:00 a.m. ET following the release.
Investors can access the live webcast via the company's investor websites (U.S., HK, SSE) and are recommended to register at least 15 minutes before the scheduled start. An archived webcast will be posted on the investor site after the event.
BeOne Medicines (NASDAQ: ONC) presented new Phase 3 and Phase 1 data at ESMO 2025 on October 17-21 showing TEVIMBRA (tislelizumab) continued clinical benefit in lung cancer and early activity for investigational HPK1 inhibitor BGB-26808. RATIONALE-307 long-term data showed TEVIMBRA plus chemotherapy significantly improved overall survival in squamous NSCLC across subgroups, despite high in-study crossover. RATIONALE-312 three-year results confirmed durable OS and safety for first-line TEVIMBRA plus chemotherapy in ES-SCLC. Phase 1a BGB-26808 plus TEVIMBRA achieved an unconfirmed ORR of 15.4% with manageable safety; Grade 3/4 TRAEs for BGB-26808 were ~21%.
BeOne Medicines (NASDAQ: ONC) announced on October 13, 2025 that the U.S. FDA granted Breakthrough Therapy Designation for sonrotoclax for adult patients with relapsed or refractory mantle cell lymphoma (MCL).
The FDA also accepted BeOne for Project Orbis review. Decisions were based on early positive topline data from a Phase 1/2 study (BGB-11417-201) after prior BTKi and anti-CD20 therapy. BeOne reported sonrotoclax also holds Fast Track and Orphan Drug designations; a Phase 3 confirmatory CELESTIAL-RRMCL study is underway.
BeOne Medicines (Nasdaq: ONC) announced positive topline results from its Phase 1/2 study of sonrotoclax, a next-generation BCL2 inhibitor, for treating relapsed/refractory mantle cell lymphoma (MCL). The study, involving 125 adult patients, met its primary endpoint of overall response rate (ORR).
The trial consisted of two parts: Part 1 with 22 patients receiving 160mg or 320mg daily doses, and Part 2 with 103 patients receiving the recommended 320mg daily dose. The treatment showed promising results across secondary endpoints, including complete response rate, duration of response, and progression-free survival, with a manageable safety profile.
BeOne plans to submit the data to the FDA and other global regulatory authorities for potential approval. The drug has already received Orphan Drug Designation from the FDA for MCL treatment.
BeOne Medicines (NASDAQ: ONC) has received European Commission approval for TEVIMBRA (tislelizumab) as a neoadjuvant/adjuvant treatment for resectable non-small cell lung cancer (NSCLC). The approval is based on the Phase 3 RATIONALE-315 trial, which demonstrated significant overall survival benefits.
Key findings from the final analysis include a statistically significant improvement in overall survival (HR=0.65) with a median follow-up of 38.5 months, and sustained event-free survival benefits (HR=0.58). The drug showed consistent benefits across major sub-groups, regardless of PD-L1 expression, disease stage, and histology.
TEVIMBRA now has nine approved indications in solid tumors in the EU, including five in lung cancer, positioning it as a comprehensive treatment option throughout the care continuum.
BeOne Medicines (NASDAQ: ONC), a global oncology company, has announced its participation in the upcoming Morgan Stanley 23rd Annual Global Healthcare Conference. The company will engage in a fireside chat on September 8, 2025, at 1:50 p.m. EDT.
Investors can access the live webcast through BeOne's investor relations websites, and an archived version will be available after the event.