BeiGene, Ltd. American Depositary Shares - BGNE STOCK NEWS

BeiGene announced positive interim results from the Phase 3 ALPINE trial, which compares BRUKINSA to ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The trial included 415 patients, with BRUKINSA showing non-inferiority in objective response rate (ORR) and statistically significant lower risk of atrial fibrillation compared to ibrutinib. The results will be presented at EHA2021, with further details discussed in an investor call.

BeiGene announced that its Phase 3 RATIONALE 309 trial evaluating tislelizumab, an anti-PD-1 antibody, in combination with chemotherapy for recurrent or metastatic nasopharyngeal cancer (NPC) successfully met its primary endpoint of progression-free survival (PFS). The interim analysis indicated a statistically significant improvement in PFS compared to chemotherapy alone. The trial included 263 patients, and the safety profile of tislelizumab remained consistent. This marks the fifth positive Phase 3 readout for tislelizumab, emphasizing its potential as a differentiated treatment option.

BeiGene, Ltd. (NASDAQ: BGNE) announced the presentation of clinical results at the 2021 ASCO Annual Meeting from June 4-8, showcasing advancements in its cancer treatment portfolio. Key highlights include initial reports from Phase 3 and Phase 2 trials of tislelizumab in various cancers and ongoing evaluations of next-generation BTK inhibitor, BRUKINSA. The company emphasizes its commitment to health equity and innovative treatments aimed at improving patient access and affordability. Presentations will be available starting June 4 at 9:00 a.m. ET via ASCO Digital Program.

BeiGene announced that the FDA has accepted a supplemental new drug application for BRUKINSA (zanubrutinib) aimed at treating adult patients with marginal zone lymphoma (MZL) who have undergone at least one prior anti-CD20 therapy. The FDA has prioritized the review, with a target action date set for September 19, 2021. This marks a significant step as MZL lacks a clear standard of care, affecting over 2,000 patients annually in the U.S. Clinical trials demonstrated promising efficacy and safety for BRUKINSA.

BeiGene, Ltd. (NASDAQ: BGNE) announced that key clinical results from its hematology program will be showcased at the EHA2021 Virtual Congress from June 9-17, 2021. The data includes promising results from the ALPINE and ASPEN trials, highlighting BRUKINSA's efficacy and tolerability across multiple B-cell malignancies. Additionally, long-term efficacy data for tislelizumab in classical Hodgkin’s lymphoma will be presented. New preliminary data for the BCL-2 inhibitor BGB-11417 is also anticipated. These updates aim to enhance patient outcomes and address unmet medical needs.

BeiGene, Ltd. (NASDAQ: BGNE) has received conditional approval from China's NMPA for pamiparib, a PARP inhibitor for gBRCA mutation-associated recurrent ovarian cancer post-chemotherapy. This marks BeiGene's third internally developed medicine to gain marketing authorization. The approval follows a pivotal Phase 2 trial showing an objective response rate of 68.3% for platinum-sensitive cases and 31.6% for platinum-resistant cases. Pamiparib is set to launch this month, and further trials are ongoing for additional indications.

BeiGene reported strong Q1 2021 results with a 104% increase in global product revenue to $106.1 million. Total revenue surged to $605.9 million, driven by a $650 million upfront payment from Novartis and positive outcomes from the ALPINE trial for BRUKINSA. The company achieved significant growth in China following NRDL inclusion for tislelizumab, BRUKINSA, and XGEVA. Net income stood at $66.5 million, a turnaround from last year's loss of $363.7 million. Cash and short-term investments totaled $4.8 billion.

BeiGene (NASDAQ: BGNE) reported positive interim results from the Phase 3 ALPINE trial, comparing BRUKINSA^® (zanubrutinib) with ibrutinib in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). BRUKINSA met the primary endpoint, showing non-inferiority in objective response rate (ORR) (p < 0.0001), and a statistically significant superior ORR compared to ibrutinib (p = 0.0006). Safety analysis indicated a lower risk of atrial fibrillation with BRUKINSA. The trial is ongoing with future assessments planned for progression-free survival.

BeiGene (NASDAQ: BGNE) has announced promising results from the interim analysis of its Phase 3 RATIONALE 303 trial, comparing the efficacy of its anti-PD-1 antibody, tislelizumab, to docetaxel in patients with advanced or metastatic non-small cell lung cancer (NSCLC). The trial showed an overall survival (OS) median of 17.2 months for tislelizumab versus 11.9 months for docetaxel, with significant improvements across various metrics. These findings support a supplemental biologics application currently under regulatory review in China.