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...
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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)...
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...