Beigene Ltd Stock Price, News & Analysis

BeiGene has initiated the Phase 1 clinical trial for BGB-23339, a novel allosteric TYK2 inhibitor aimed at treating inflammation and immunology disorders. This candidate has exhibited potent inhibition of inflammatory cytokines in preclinical studies and represents the first internally developed asset in this therapeutic area. The trial aims to evaluate the drug's safety, tolerability, and preliminary efficacy in up to 115 healthy volunteers across Australia and China. This development expands BeiGene’s portfolio beyond oncology.

BeiGene has announced that BRUKINSA (zanubrutinib) received approval from the Saudi Food and Drug Authority for treating adult patients with mantle cell lymphoma (MCL) who have undergone at least one prior therapy. With this approval, BRUKINSA is now authorized in 11 countries, including the U.S., China, Canada, and Australia. The company is collaborating with NewBridge Pharmaceuticals to enhance BRUKINSA's availability in the Middle East and North Africa (MENA) region. This milestone reflects BeiGene's commitment to expanding access to effective cancer therapies.

BeiGene reported a remarkable third quarter with product revenue reaching $192.5 million, up 111% from $91.1 million year-over-year. Key approvals for BRUKINSA in the U.S. include new indications, while the FDA accepted the first BLA for tislelizumab targeting esophageal cancer. Total revenue for the quarter was $206.4 million, with a net loss of $413.9 million. Cash and equivalents totaled $3.9 billion. The company continues to expand its global footprint, emphasizing affordability and accessibility for cancer treatments.

BeiGene announced positive results from the SEQUOIA trial, showcasing that BRUKINSA (zanubrutinib) outperforms traditional chemoimmunotherapy in patients with treatment-naïve chronic lymphocytic leukemia (CLL). Achieving significant improvements in progression-free survival, the data reflects strong efficacy with low rates of atrial fibrillation, a common side effect of other treatments. Additional findings suggest BRUKINSA's potential for patients intolerant to existing BTK inhibitors. These results will be presented at the American Society of Hematology meeting from December 11-14, 2021.

BeiGene announced that BRUKINSA (zanubrutinib) received regulatory approval in Russia for treating adult patients with mantle cell lymphoma (MCL) who have undergone at least one prior therapy. This marks the first approval of BRUKINSA in Russia, expanding its reach to ten countries globally. The drug, distributed exclusively by Nanolek, showed an overall response rate of 83.7% in clinical trials. The approval reinforces BRUKINSA's status as a competitive treatment option for patients with MCL.

BeiGene announced the approval of BRUKINSA® (zanubrutinib) in Australia for adults with mantle cell lymphoma (MCL) who have undergone at least one prior therapy. This marks the second indication for BRUKINSA in Australia, following its initial approval for Waldenström’s macroglobulinemia in October 2021. Currently, BRUKINSA is authorized in nine countries for MCL. With an overall response rate of 83.7% from clinical trials, the new indication provides patients with critical treatment options as MCL is typically hard to treat and often diagnosed late.

BeiGene has announced that BRUKINSA (zanubrutinib) has received approval in Australia for treating mantle cell lymphoma (MCL) in adult patients who have undergone at least one prior therapy. This marks the drug's second approved indication in Australia, following its initial approval for Waldenström's macroglobulinemia. To date, BRUKINSA is approved in nine countries for MCL. The drug achieved an overall response rate of 83.7% in clinical trials, reflecting its potential as a new treatment option for MCL patients in Australia.

BeiGene has announced that its drug BRUKINSA (zanubrutinib) has received approval from the Australia Therapeutic Goods Administration for treating adult patients with Waldenström’s macroglobulinemia who have undergone at least one prior therapy or are first-line treatment candidates. This follows a recent approval in Singapore for the treatment of mantle cell lymphoma. The approval is based on results from the ASPEN clinical trial, which showed BRUKINSA's higher response rates and improved tolerability compared to ibrutinib.

BeiGene has received TGA approval in Australia for its BTK inhibitor BRUKINSA (zanubrutinib), aimed at treating adult patients with Waldenström’s macroglobulinemia (WM) who have had prior therapy or are unsuitable for chemo-immunotherapy. This follows a recent approval in Singapore for treating mantle cell lymphoma patients. The approval is based on the ASPEN trial, which showed BRUKINSA's efficacy versus ibrutinib. Immediate access will be provided through a BeiGene-sponsored program.