BeiGene, Ltd. American Depositary Shares - BGNE STOCK NEWS

BeiGene announced that its New Drug Application (NDA) for pamiparib has received priority review status from the Center for Drug Evaluation (CDE) of the NMPA in China. Pamiparib is an investigational drug aimed at treating patients with BRCA-mutated advanced ovarian cancer who have undergone multiple chemotherapy lines. This marks BeiGene's third drug to achieve priority status in China. With over 1,200 patients enrolled in trials, pamiparib is also being explored in various solid tumors, indicating significant progress in biotechnology and cancer treatment advancement.

BeiGene has announced the acceptance of a new drug application (NDA) for pamiparib, an investigational PARP inhibitor, by the Center for Drug Evaluation in China. This NDA targets patients with deleterious or suspected deleterious BRCA-mutated advanced ovarian cancer treated with two or more chemotherapy lines. The application is backed by clinical data from a Phase 1/2 trial involving 113 patients. The company aims to offer new treatment options for this patient group and will present further clinical data soon.

BeiGene, a biotechnology company focused on cancer treatments, has successfully completed a direct offering of 145,838,979 ordinary shares at a price of $14.2308 per share, raising approximately $2.08 billion in gross proceeds. The offering, executed without an underwriter, allows BeiGene to enhance its financial position and further invest in its oncology pipeline.

The shares were provided under an automatically effective shelf registration statement previously filed with the SEC. This move signifies BeiGene's commitment to expanding its innovative cancer therapies.

BeiGene, a biotechnology company, announced a registered direct offering of 145,838,979 ordinary shares at $14.2308 each, resulting in approximately $2.08 billion in gross proceeds. The offering, made without underwriters, is set to close around July 15, 2020. Net proceeds, estimated at $2.07 billion after expenses, will be used for working capital and general corporate purposes. The offering is registered under an effective shelf registration statement filed with the SEC. Credit Suisse is advising on the offering.

BeiGene, a biotechnology company, announced the acceptance of a supplemental new drug application (sNDA) for its anti-PD-1 antibody, tislelizumab, to treat patients with previously treated unresectable hepatocellular carcinoma (HCC) in China. HCC is a prevalent type of liver cancer, especially in China, where unmet medical needs are significant. The sNDA is based on pivotal Phase 2 trial results involving 249 patients. The company aims to provide a viable treatment option for HCC patients, enhancing its oncology pipeline, which includes other ongoing trials for tislelizumab.

BeiGene has commenced the commercialization of XGEVA (denosumab) in China for treating giant cell tumor of bone (GCTB), marking a significant milestone in its strategic partnership with Amgen. XGEVA, approved by China's NMPA in May 2019, offers a novel therapy for GCTB, which typically requires surgical intervention. Clinical trials have shown promising results, with an 88% five-year progression-free survival rate. The company aims to leverage its extensive commercial organization to enhance patient access to innovative oncology treatments in China.

BeiGene, Ltd. (NASDAQ: BGNE) announced that the Center for Drug Evaluation of China's NMPA accepted a supplemental new drug application for tislelizumab in combination with chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC). This marks the second sNDA for tislelizumab in this indication. Clinical results supporting the application came from a Phase 3 trial, which showed a statistically significant improvement in progression-free survival. The drug has already secured regulatory approval for other cancer indications in China.

BeiGene, Ltd. (BGNE) announced that the European Medicines Agency has validated its marketing authorization application for BRUKINSA® (zanubrutinib) to treat Waldenström’s macroglobulinemia (WM) in patients with prior therapy or as a first-line treatment for those unsuited for chemo-immunotherapy. This marks BeiGene's first submission for WM, highlighting BRUKINSA's efficacy and safety compared to ibrutinib in the ASPEN trial. BRUKINSA has received approvals in the U.S. and China for different indications, and the company aims to expand its global development efforts.

BeiGene, Ltd. (BGNE) announced positive clinical data for its BTK inhibitor zanubrutinib and anti-PD-1 antibody tislelizumab at the 25th European Hematology Association (EHA) Virtual Congress. Zanubrutinib showed an overall response rate (ORR) of 80% in relapsed/refractory marginal zone lymphoma (MZL), with a complete response rate of 15%. The drug was well tolerated with main adverse events being grade 1 or 2. Tislelizumab presented an ORR of 31.8% in extranodal NK/T-cell lymphoma. The encouraging results provide a foundation for further trials and potential registrations.