BEIJING & CAMBRIDGE, Mass. – BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the China National Medical Products Administration (NMPA) has conditionally approved KYPROLIS® (carfilzomib) for injection in combination with dexamethasone for the treatment of adult patients with relapsed...
Latest News
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...
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...
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...
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)...
HAYWARD, Calif. – Benitec Biopharma Inc. (NASDAQ: BNTC), a development-stage biotechnology company focused on the advancement of novel genetic medicines, today announced significant progress regarding the regulatory interactions in Europe required to support advancement of the BB-301 development program towards the Phase 1b/2a clinical study in 2022. Benitec also confirmed the scheduling of an...
HAYWARD, Calif. — Benitec Biopharma Inc. (NASDAQ: BNTC), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference (“ddRNAi”) platform, today announces positive interim clinical data from the 90-day timepoint following the administration of BB-301 to the study’s first subject...