Beigene Ltd Stock Price, News & Analysis

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Investors can access the live webcast through BeOne's investor relations websites, and an archived version will be available after the event.

BeOne Medicines (Nasdaq: ONC) has entered into a significant royalty purchase agreement with Royalty Pharma for up to $950 million for IMDELLTRA® worldwide sales rights (excluding China). The deal includes an $885 million upfront payment and a potential additional $65 million within 12 months.

IMDELLTRA® is a groundbreaking DLL-3 targeting bispecific T-cell engager approved for treating extensive-stage small cell lung cancer (ES-SCLC) patients who have progressed after platinum-based chemotherapy. BeOne will retain a portion of royalties on annual sales above $1.5 billion and maintain rights to other assets under its Amgen collaboration, including xaluritamig.

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.