BeOne Medicines Ltd. Stock Price, News & Analysis

BeOne Medicines (NASDAQ: ONC) announced that on December 18, 2025 the U.S. FDA granted Fast Track Designation for BGB-B2033, a bispecific antibody targeting GPC3 and 4-1BB for treatment of adult patients with hepatocellular carcinoma (HCC) with disease progression after prior systemic therapy. The designation highlights the program's potential in an area of high unmet need.

BeOne is conducting a global, multi-center Phase 1 trial (NCT06427941) to evaluate safety and anti-tumor activity of BGB-B2033 as monotherapy and in combination with PD-1 inhibitor TEVIMBRA (tislelizumab).

BeOne Medicines (NASDAQ: ONC) presented long‑term CLL data at ASH 2025 showing BRUKINSA (zanubrutinib) achieved an estimated 74% 6‑year PFS versus 32% for bendamustine+rituximab in treatment‑naïve CLL/SLL (SEQUOIA).

Other key BRUKINSA results: 72‑month OS ~84% (88% COVID‑adjusted), durable benefit in del(17p) patients, BRUKINSA+venetoclax 36‑month PFS 87% with sustained uMRD, and ALPINE long‑term BRUKINSA median PFS 52.5 months. NCCN now lists zanubrutinib+venetoclax as a preferred first‑line option.

Investigational BTK degrader BGB‑16673 showed deep responses in heavily pretreated R/R CLL: overall ORR 85.3%, RP2D ORR 94.4%, and 12/18‑month PFS of 73.5%/65.9%.

BeOne Medicines (NASDAQ: ONC) reported ASH 2025 data showing the investigational BCL2 inhibitor sonrotoclax produced durable monotherapy responses in relapsed/refractory mantle cell lymphoma (R/R MCL) and relapsed/refractory CLL/SLL, and rapid, deep uMRD rates in treatment‑naive CLL when combined with BTK inhibitor and anti‑CD20 agents.

Key figures include ORR 52.4% in R/R MCL (n=103), median DOR 15.8 months (follow‑up 14.2 months), ORR 100% for sonrotoclax+zanubrutinib (320 mg cohort) and uMRD4 91% at 48 weeks. FDA and NMPA accelerated‑approval reviews are underway.

BeOne Medicines (Nasdaq: ONC) announced the U.S. FDA has accepted and granted Priority Review to the NDA for sonrotoclax, a next‑generation BCL2 inhibitor for adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after prior BTK inhibitor therapy.

The NDA is supported by a global Phase 1/2 single‑arm study of 125 patients that met its primary endpoint of overall response rate (IRC‑assessed) and showed promising CR, DOR, and PFS results with a manageable safety profile. Full data will be presented at ASH 2025 (oral, Dec 7).

BeOne plans Project Orbis participation and submissions to other regulators including EMA and China NMPA.

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.