BeOne Medicines Ltd. Stock Price, News & Analysis

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 An archived version of the webcast will be available for later viewing.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.

BeOne Medicines (NASDAQ: ONC) presented breakthrough clinical data at EHA 2025 for their hematology assets. Their BCL2 inhibitor sonrotoclax combined with BRUKINSA showed impressive results with 96% ORR in R/R CLL and 79% ORR in R/R MCL patients. The BTK degrader BGB-16673 demonstrated strong efficacy with 84.8% ORR in R/R CLL/SLL and 84.4% ORR in Waldenström macroglobulinemia. Long-term BRUKINSA data from the SEQUOIA trial showed sustained benefits with 72.2% progression-free survival at 60 months in CLL patients with del(17p). The combination of BRUKINSA plus venetoclax achieved 97% ORR and 92% 24-month PFS rate. These results support advancement into Phase 3 studies and potential regulatory submissions.

BeOne Medicines announced FDA approval of a new tablet formulation of BRUKINSA (zanubrutinib) for all five approved indications. The new 160mg tablets reduce pill burden from four 80mg capsules to two tablets daily while maintaining the 320mg recommended daily dose. BRUKINSA has become the overall BTK inhibitor market share leader and leads in new chronic lymphocytic leukemia patient starts across all therapy lines in the U.S. The tablet formulation, which offers the same efficacy and safety as capsules based on Phase 1 studies, features a film coating for easier swallowing. BRUKINSA remains the only BTK inhibitor offering flexible once or twice daily dosing and recommended dosing for severe hepatic impairment. The tablets will replace capsules starting October 2025, with EMA approval expected later this year.

BeOne Medicines (NASDAQ: ONC) has announced an upcoming Investor R&D Day event scheduled for June 26, 2025, at 8:30 am ET, to be held in New York City with a simultaneous webcast option. The event will feature presentations from CEO John V. Oyler and the company's leadership team, along with key opinion leaders. They will provide updates on BeOne's global innovation pipeline, platforms, new assets, targets, and clinical data. The company will also share insights on its vision, capabilities, and value creation strategies. Investors can access the webcast through BeOne's investor relations websites, with registration recommended 15 minutes before the event. An archived version will be available afterward.