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

GRAIL shares surged roughly 35% after FDA briefing materials raised no major concerns about the accuracy, study design or primary safety analyses of its Galleri blood test, which screens for more than 50 cancers. The FDA’s advisory committee is scheduled to review and vote on Galleri’s premarket approval application on September 23, though its recommendation will be nonbinding and the agency has specifically asked whether the evidence supports calling the test an “early detection” tool. Investors interpreted the documents as favorable, despite lingering questions about Galleri’s roughly one-third sensitivity and results from a U.K. trial that did not significantly improve early detection or reduce late-stage diagnoses. GRAIL reported second-quarter revenue of $44.7 million, up 26% year over year, while selling more than 61,000 tests, but it still posted a $110.2 million net loss and a wider adjusted EBITDA loss. FDA approval could expand distribution, physician adoption and insurance coverage, while a negative panel recommendation or continued operating losses could undermine the rally.