Grail's Galleri Cancer Test Misses Primary Endpoint in NHS Trial, Shares Plunge Despite Positive Trends

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GRAIL announced topline results from the NHS-Galleri trial on February 19, 2026, involving 142,000 participants aged 50-77 over three years.12

The trial failed to meet its primary endpoint of statistically significant reduction in combined Stage III-IV cancer diagnoses, though a favorable trend was observed, particularly a substantial reduction in Stage IV diagnoses.12

Galleri showed increased Stage I and II detection for deadly cancers and a four-fold higher cancer detection rate; test performance (PPV, specificity, CSO accuracy) was consistent with prior studies.1

No serious safety concerns reported; GRAIL plans U.S. sales force expansion based on these and PATHFINDER 2 results, despite analysts citing risks to FDA approval and Medicare coverage.12

Company shares tumbled about 50% following the announcement.2

Sources:

1. https://grail.com/press-releases/landmark-nhs-galleri-trial-demonstrates-a-substantial-reduction-in-stage-iv-cancer-diagnoses-increased-stage-i-and-ii-detection-of-deadly-cancers-and-four-fold-higher-cancer-detection-rate/

2. https://www.biopharmadive.com/news/grails-multi-cancer-early-detection-test-misses-study-goal/812744/