GRAIL Shares Surge 35% After FDA Briefing Raises No Major Concerns

GRAIL shares surged roughly 35 percent on September 21, 2026, rising to $108.78 from a prior close of $80.77 within a session range of $92.00 to $111.49 on volume of 2.82 million shares, or 3.31 times the 20-day average. The rally followed FDA staff briefing documents on Galleri, which screens for more than 50 cancer types including more than 45 with no standard screening. An advisory committee votes September 23 on Galleri’s premarket approval application. The vote is nonbinding, and the FDA asked whether evidence supports calling the test an early detection tool. Independent Journal Review and wire accounts said the briefing materials raised no major concerns; Seeking Alpha described a positive evaluation. CONTESTED: Wire reports put second-quarter revenue at $44.7 million, up 26 percent; AInvest put it at $42.6 million, up 24 percent. Both cite more than 61,000 tests sold and a $110.2 million net loss. GRAIL held $861.6 million in cash. A director filed a Form 144 proposed share sale during the rally. In February the NHS-Galleri trial missed its primary endpoint, the stock halved, and securities fraud suits followed. Josh Ofman said, "GRAIL continues to execute across our clinical and commercial priorities." Approval could expand distribution and coverage; a negative recommendation or continued losses could reverse the move.