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Name | Symbol | Market | Type |
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BeiGene Ltd | NASDAQ:BGNE | NASDAQ | Depository Receipt |
Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
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-0.73 | -0.45% | 162.54 | 158.70 | 166.50 | 165.50 | 161.70 | 163.82 | 101,487 | 01:00:00 |
By Chris Wack
BeiGene said Friday that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval for tislelizumab to treat adults with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma.
The biotechnology company said the marketing authorization application for esophageal squamous cell carcinoma is based on results from its Phase 3 study of tislelizumab's efficacy and safety.
The study enrolled 513 patients in 11 countries in Asia, Europe and North America. The study met its primary endpoint with a statistically significant and clinically meaningful survival benefit for tislelizumab compared with chemotherapy.
Tislelizumab isn't currently authorized for use in Europe.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
July 21, 2023 08:18 ET (12:18 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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