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

Dow Jones
09/23
 
 

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.

 
 

應版權方要求,你需要登入查看該內容

免責聲明:投資有風險,本文並非投資建議,以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請,作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考,不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證,投資者應自行研究並在投資前尋求專業建議。

熱議股票

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