Grail Gains From More Focused FDA Review Before Galleri Advisory Panel, UBS Says

MT Newswires Live
09/23

Grail (GRAL) faces an "incrementally positive" shift toward a narrower and more focused Food and Drug Administration debate ahead of Wednesday's advisory committee meeting on Galleri, its multicancer early detection test, UBS Securities said in a report.

The FDA briefing documents show the agency has no major outstanding questions about Galleri's analytical performance, bridging analyses or primary safety results, UBS said Monday in the report. Instead, the panel discussion is expected to center on how the test should be positioned and labeled.

A key issue is whether Galleri's stage-specific performance supports an "early detection" claim and how broadly any clinical benefit should be reflected in the final indication, the report said. UBS said it still expects FDA approval.

UBS reiterated its buy rating on Grail stock with a $105 price target.

Price: 108.40, Change: +0.43, Percent Change: +0.40

免责声明:投资有风险,本文并非投资建议,以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请,作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考,不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证,投资者应自行研究并在投资前寻求专业建议。

热议股票

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