Grail Shares Surge 35% as FDA Staff Flag No Major Concerns Over Galleri Cancer Test

Shares of Grail jumped 35% on Monday after U.S. FDA staff reviewers raised no major concerns about the accuracy and safety of its Galleri blood test, which screens for more than 50 cancers. The findings will be reviewed at an FDA external advisers' meeting on Wednesday regarding Grail's premarket approval request. The FDA has no outstanding questions for the panel on analytical performance, study design, or primary safety analyses, according to briefing documents. However, the agency asked advisers to discuss whether evidence supports Galleri's "early detection" characterization. Piper Sandler analyst David Westenberg called the development constructive and expects a favorable vote. Grail shares had fallen over 20% since February after a UK trial showed routine screening did not significantly boost early detection or reduce late-stage diagnoses. The test generated $136.8 million in U.S. revenue in 2025.