Beigene Ltd Stock Price, News & Analysis

BeiGene, Ltd. (NASDAQ: BGNE) announced Health Canada's approval of BRUKINSA (zanubrutinib) for treating adults with Waldenström’s macroglobulinemia (WM). This BTK inhibitor aims to provide deep, durable responses while minimizing side effects. Approval follows promising results from the ASPEN trial, which indicated a higher very good partial response rate than ibrutinib, although it did not meet the primary endpoint of deep response superiority. BRUKINSA is set for market availability in Canada in the coming weeks.

BeiGene, Ltd. (NASDAQ: BGNE) announced the completion of a collaboration and license agreement with Novartis Pharma AG for the anti-PD-1 antibody tislelizumab. This agreement, initially announced in January 2021, allows joint development and commercialization in several regions. BeiGene will receive $650 million upfront, with potential earnings of up to $1.3 billion for regulatory milestones. They will also receive royalties on future sales. Tislelizumab has shown positive Phase 3 trial results for advanced esophageal squamous cell carcinoma and is approved in China in combination with chemotherapy for lung cancer.

BeiGene reported significant business highlights and financial results for Q4 and full year 2020. Notable achievements include product revenues of $100 million for Q4 and $309 million for the year, marking increases of 76% and 39% year-over-year, respectively. The company announced successful Phase 3 trial results for its drug tislelizumab and a collaboration with Novartis for its development in North America and Europe. Despite these advancements, BeiGene recorded a net loss of $472.75 million for Q4 and $1.60 billion for the year, reflecting ongoing R&D expenses.

BeiGene (NASDAQ: BGNE) has entered into an option and license agreement with Boston Immune Technologies and Therapeutics (BITT) to develop TNFR2 antagonist antibodies, aimed at cancer treatment. BITT's lead candidate, BITR2101, will undergo Phase 1 clinical trials alongside BeiGene's tislelizumab. The agreement includes an upfront payment and milestone payments totaling $16.6 million, with potential additional payments up to $105 million. This collaboration is seen as a validation of BITT's antibody platform and has the potential to improve treatment options for cancer patients.

BeiGene, Ltd. (NASDAQ: BGNE) announced FDA acceptance of a supplemental new drug application for BRUKINSA® (zanubrutinib) to treat Waldenström’s Macroglobulinemia (WM) in adults. The PDUFA target action date is October 18, 2021. The sNDA is based on data from 351 patients, primarily from the Phase 3 ASPEN trial, comparing zanubrutinib's safety and efficacy against ibrutinib. BRUKINSA is under regulatory review in multiple countries, with over 20 marketing applications submitted globally. The drug is currently approved for mantle cell lymphoma in the US and China.

BeiGene, Ltd. (NASDAQ: BGNE) announced positive results from its global Phase 3 RATIONALE 302 trial for tislelizumab in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma. The trial met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) compared to chemotherapy. The safety profile was consistent with known risks, with no new safety signals. This marks BeiGene's fourth positive Phase 3 readout for tislelizumab, reinforcing its potential as a treatment option for patients with advanced esophageal cancer.

BeiGene, Ltd. (NASDAQ: BGNE) announced that its anti-PD-1 antibody, tislelizumab, received approval from the China National Medical Products Administration (NMPA) for use in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (NSCLC). This marks the third approval in China for tislelizumab and its first for lung cancer. The approval follows positive interim results from the RATIONALE 303 trial, demonstrating significant benefits in overall survival.

BeiGene, Ltd. (NASDAQ: BGNE) announced a collaboration with Novartis Pharma AG to develop and commercialize its anti-PD-1 antibody, tislelizumab, in the U.S., Canada, and several European and Asian countries. Novartis will oversee regulatory submissions and commercialization. BeiGene will receive $650 million upfront and could earn up to $1.3 billion in regulatory milestones, alongside royalties on future sales. Tislelizumab is already approved in China for specific cancer treatments, with ongoing clinical trials aimed at expanding its indications.

Strand Therapeutics and BeiGene (NASDAQ: BGNE) have entered into a licensing agreement for the development of multi-functional mRNA treatments targeting solid tumors. BeiGene gains options for exclusive licenses to two immuno-oncology programs in Asia (excluding Japan), Australia, and New Zealand. Strand will receive an upfront payment of $5 million, with potential additional payments totaling up to $28 million, and a total deal value of up to $277 million, including royalties on product sales. This collaboration aims to enhance patient access to innovative therapies.