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Beigene Ltd - ONC STOCK NEWS

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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.

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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.

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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.

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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.

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BeiGene (NASDAQ: ONC) reported strong financial results for Q4 and full year 2024, with total global revenues reaching $1.1 billion in Q4 (78% increase) and $3.8 billion for the full year (55% increase). Their flagship product BRUKINSA generated revenues of $828 million in Q4 and $2.6 billion annually, showing remarkable growth of 100% and 105% respectively.

The company provided 2025 revenue guidance of $4.9-5.3 billion and expects positive GAAP operating income and cash flow. BRUKINSA has become the market leader in new CLL patient starts in the U.S., with U.S. sales reaching $616 million in Q4 and $2.0 billion for the full year. European sales showed strong growth at $113 million in Q4 and $359 million annually.

The company advanced 13 New Molecular Entities into clinical trials during 2024 and anticipates multiple data readouts for innovative solid tumor programs in 1H 2025. BeiGene plans to change its name to BeOne Medicines , reflecting its evolution as a global oncology powerhouse.

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BeiGene, (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company planning to rebrand as BeOne Medicines , has announced its participation in two upcoming investor conferences.

The company will engage in fireside chats at the TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025, at 9:10 am ET, and the Leerink Partners Global Biopharma Conference on Monday, March 10, 2025, at 1:00 pm ET.

Investors can access live webcasts of both events through BeiGene's investor relations websites. Archived replays will remain available for 90 days following each conference.

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BeiGene (NASDAQ: ONC) has scheduled the release of its fourth quarter and full year 2024 financial results for Thursday, February 27, 2025, before market open. The company, which plans to change its name to BeOne Medicines, will host a live webcast with management at 8:00 a.m. ET following the financial release.

Investors can access the webcast through BeiGene's investor relations websites. Participants are advised to register 15 minutes before the scheduled start time to ensure proper connection. An archived version of the webcast will be made available on the company's website afterward.

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BeiGene (NASDAQ: ONC) has appointed Giancarlo Benelli as Senior Vice President and Head of Europe, effective January 1st. The company, which plans to change its name to BeOne Medicines , aims to strengthen its European presence through this strategic appointment. Benelli brings over 20 years of pharmaceutical industry experience from positions at Novartis and AstraZeneca, most recently serving as Vice President and Head Radioligand Therapy International Markets at Novartis.

Benelli will lead BeiGene's European operations from Basel, Switzerland, overseeing more than 800 colleagues across the region. His previous experience includes serving as General Manager at Advanced Accelerators Applications, where he managed post-acquisition restructuring and successful product launches. He holds a Medical Doctorate and Post Graduate Diploma in Thoracic Surgery from the University of Genoa, and a Diploma in Health Economics from the University of York.

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