Grail Trading Halted Ahead of FDA AdCom Meeting on Galleri Blood Test

Dow Jones
Sep 23
 
 

Trading in shares of Grail is halted on Wednesday ahead of a Food and Drug Administration advisory committee meeting to discuss the diagnostic company's proposed multi-cancer blood test.

Grail is seeking FDA approval of Galleri, a blood test that aims to catch cancers before symptoms appear.

Shares of the Menlo Park, Calif., company were up 34% this week through Tuesday's close after FDA briefing documents for the meeting, released on Monday, were more favorable than investors had expected.

RBC Capital Markets analyst Dan Leonard said the briefing documents suggest the FDA is less concerned with Galleri's safety and effectiveness and more focused on how to label the commercial product.

The FDA often turns to advisory committees to obtain advice from experts who work outside of the government when a scientific, technical or policy question arises, such as whether an unapproved product is safe and effective. The agency usually follows the advice of its advisory committees but it isn't bound by the recommendations.

 
 

At the request of the copyright holder, you need to log in to view this content

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10