CAMBRIDGE, Mass. & BEIJING – BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for its anti-PD-1 antibody tislelizumab...
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CAMBRIDGE, Mass. & BEIJING – BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today presented results from the interim analysis of the Phase 3 ALPINE trial comparing its BTK inhibitor BRUKINSA® (zanubrutinib) to ibrutinib in adult patients with relapsed or...
Positive opinion for TEVIMBRA in combination with chemotherapy as a first-line treatment of nasopharyngeal cancer (NPC) based on results of RATIONALE-309 study demonstrating statistically significant improvement in progression-free survival SAN CARLOS, Calif. — BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that will change its name to...
BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. — BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of tislelizumab as a treatment for...
SHANGHAI, China — Belief BioMed Group (BBM), an industry-leading biotech company focusing on innovative gene therapies, announced the completion of first subject dosing in its registrational clinical trial (CTR20233400) of BBM-H803, a gene therapy for hemophilia A, independently developed and produced by Belief BioMed. BBM-H803 is Belief BioMed’s first gene...
Designation is based on the pivotal Phase 3 DRAGON trial interim analysis results demonstrating Tinlarebant’s efficacy and favorable safety profile Trial completion expected by Q4 2025 (including a three-month follow-up period) Tinlarebant has previously been granted Fast Track and Rare Pediatric Disease Designations in the U.S., Orphan Drug Designation in...
SAN DIEGO, Calif. — Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio” or the “Company”) today announced topline results from the global Phase 3 “DRAGON” trial of Tinlarebant, marking the first successful pivotal trial in patients with Stargardt disease type 1 (STGD1). STGD1 is an eye disease that leads to progressive...
SAN DIEGO, Calif. — Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced additional findings from the 24-month Phase 2 study of Tinlarebant in adolescent Stargardt disease (STGD1) at the Association...
Phase 2 results provide a clinically meaningful reduction in pulmonary vascular resistance; Company intends to design a multi-dose Phase 2b trial Treatment was safe and well-tolerated, with no treatment-emergent adverse events observed during the acute hemodynamic dose-escalation phase of the study WARREN – Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (“Bellerophon” or...
Results from a Phase II trial led by researchers at The University of Texas MD Anderson Cancer Center showed that treatment with belzutifan, a small-molecule inhibitor of hypoxia-inducible factor (HIF)-2a, achieved strong clinical activity in patients with renal cell carcinomas (RCC) and non-renal cell carcinoma neoplasms associated with von Hippel-Lindau (VHL)...