BeOne Medicines Ltd. Stock Price, News & Analysis

BeiGene (NASDAQ: ONC) will present 23 abstracts at the 2025 ASCO Annual Meeting (May 30-June 3) showcasing their oncology portfolio. Key highlights include:

Two rapid oral presentations featuring BRUKINSA® (zanubrutinib) data from the SEQUOIA trial in chronic lymphocytic leukemia (CLL), including: - Long-term follow-up results from Arm C in treatment-naïve CLL patients with del(17p) mutations - First results from Arm D evaluating BRUKINSA plus venetoclax combination therapy

The company will present early-phase data for novel breast cancer treatments: - BG-C9074: A B7-H4-targeting antibody-drug conjugate for advanced solid tumors - BG-68501: A CDK2 inhibitor for HR+/HER2- breast cancer - TEVIMBRA®: Final analysis showing promising efficacy in esophageal squamous cell carcinoma

The presentations demonstrate BeiGene's commitment to advancing cancer treatment across multiple fronts, from hematologic malignancies to solid tumors.

BeiGene (NASDAQ: ONC) will present extensive data from its hematology portfolio at the EHA 2025 Congress in Milan, featuring 31 abstracts, including four oral presentations. The presentations highlight data from BRUKINSA® (zanubrutinib) and two investigational assets: sonrotoclax (BCL2 inhibitor) and BGB-16673 (BTK protein degrader). The pipeline assets have enrolled over 2,500 patients globally and show promising clinical activity in B-cell malignancies. Key highlights include updated Phase 1 results for BGB-16673 in CLL/SLL and WM patients, sonrotoclax's combination with BRUKINSA in various conditions, and results from the SEQUOIA study evaluating BRUKINSA in CLL/SLL patients. The company, soon to be renamed BeOne Medicines Ltd., aims to transform treatment standards in hematology through next-generation innovation.

BeiGene (NASDAQ: ONC), a global oncology company, has announced its participation in the upcoming RBC Capital Markets Global Healthcare Conference. The company, which will be renamed to BeOne Medicines Ltd., will engage in a fireside chat on May 20, 2025, at 10 a.m. EDT. Investors can access the live webcast through the company's investor relations websites, and an archived replay will remain available for one year after the event.

BeiGene (ONC) reported strong Q1 2025 financial results with total revenues increasing 49% to $1.1 billion. BRUKINSA global sales grew 62% to $792 million, leading in U.S. CLL patient starts. The company achieved its first GAAP profitability with net income of $1.27 million, compared to a $251.2 million loss in Q1 2024. U.S. product revenue reached $563 million, while European BRUKINSA sales grew 73% to $116 million. The company maintained its 2025 guidance of $4.9-5.3 billion in total revenue. BeiGene secured shareholder approval to rename to BeOne Medicines Ltd. and redomicile to Switzerland. The company continues advancing its late-stage hematology and solid tumor pipelines, with multiple proof-of-concept readouts expected this year across antibody-drug conjugates, multispecific antibodies, and targeted protein degraders.

BeiGene has secured a significant legal victory as the U.S. Patent and Trademark Office (USPTO) invalidated all challenged claims of Pharmacyclics' Patent No. 11,672,803. This ruling comes in response to BeiGene's post-grant review petition filed on November 1, 2023, following Pharmacyclics' patent infringement lawsuit regarding BRUKINSA (zanubrutinib).

The USPTO's Final Written Decision, while appealable by Pharmacyclics, supports BeiGene's position that the '803 patent was overly broad and invalid. BRUKINSA, BeiGene's independently developed medicine for B-cell malignancies, has received approvals in over 70 countries and regions.

BeiGene, which plans to change its name to BeOne Medicines, maintains confidence in their intellectual property rights supporting BRUKINSA, which continues to establish new standards in patient care worldwide.

BeiGene (NASDAQ: ONC) announced it will release its first quarter 2025 financial results on Wednesday, May 7, 2025, before market open. The company, which plans to change its name to BeOne Medicines , will host a live management webcast at 8:00 a.m. ET on the same day.

Participants can access the webcast through the investors section of BeiGene's website and are advised to register 15 minutes before the scheduled start. The webcast recording will be archived on the company's website.

BeiGene (NASDAQ: ONC) announced the discontinuation of its clinical development program for ociperlimab (BGB-A1217), an anti-TIGIT antibody intended for lung cancer treatment. The decision follows a recommendation from the Independent Data Monitoring Committee to terminate the ongoing Phase 3 AdvanTIG-302 trial after a pre-planned futility analysis indicated the study was unlikely to meet its primary endpoint of overall survival.

The company reported no new safety signals were observed during the trial. BeiGene, which plans to change its name to BeOne Medicines , will share the study results in the future to contribute to the scientific understanding of anti-TIGIT activity. The company maintains its focus on developing innovative and accessible cancer treatments.

BeiGene (NASDAQ: ONC) received a positive CHMP opinion recommending approval of TEVIMBRA® (tislelizumab) in combination with etoposide and platinum chemotherapy for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).

The recommendation is based on the RATIONALE-312 Phase 3 study results, which demonstrated significant survival benefits. The study of 457 patients showed median overall survival of 15.5 months for TEVIMBRA with chemotherapy versus 13.5 months for placebo plus chemotherapy, representing a 25% reduction in death risk (HR 0.75).

TEVIMBRA is already approved in the EU for multiple indications including esophageal squamous cell carcinoma (ESCC), gastric/gastroesophageal junction adenocarcinoma, and non-small lung cancer. The drug has received 58 regulatory approvals in 18 months and is being studied in combination with other molecules.

BeiGene (NASDAQ: ONC) announced FDA approval for TEVIMBRA® (tislelizumab-jsgr) in combination with platinum-containing chemotherapy for first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) with PD-L1 expression (≥1).

The approval is based on the RATIONALE-306 Phase 3 study (n=649), which demonstrated significant overall survival benefits. In PD-L1 positive patients (n=481), median overall survival reached 16.8 months for TEVIMBRA plus chemotherapy compared to 9.6 months for placebo plus chemotherapy, representing a 34% reduction in death risk (HR: 0.66).

Common adverse reactions included anemia, fatigue, decreased appetite, nausea, and constipation. This marks BeiGene's third FDA approval in less than a year, with TEVIMBRA also approved for second-line ESCC treatment and first-line gastric/gastroesophageal junction cancers.