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BGNE BeiGene Ltd

164.44
3.88 (2.42%)
After Hours
Last Updated: 00:12:12
Delayed by 15 minutes
Name Symbol Market Type
BeiGene Ltd NASDAQ:BGNE NASDAQ Depository Receipt
  Price Change % Change Price Bid Price Offer Price High Price Low Price Open Price Traded Last Trade
  3.88 2.42% 164.44 160.00 163.47 168.46 161.38 165.49 220,950 00:12:12

FDA Gives Accelerated Approval to BeiGene's Brukinsa

14/11/2019 9:37pm

Dow Jones News


BeiGene (NASDAQ:BGNE)
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   By Stephen Nakrosis 
 

The U.S. Food and Drug Administration said Thursday it had granted accelerated approval to BeiGene Ltd.'s (BGNE) Brukinsa, or zanubrutinib, for the treatment of certain adult patients with lymphoma.

The FDA said the approval was granted "for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy."

According to the FDA, clinical trials showed 84% of patients saw tumor shrinkage with BeiGene's therapy.

BeiGene's application was given a breakthrough therapy designation, the FDA said, which "expedites the development and review of drugs that are intended to treat a serious condition."

 

--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

 

(END) Dow Jones Newswires

November 14, 2019 16:22 ET (21:22 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.

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