GRAIL reports Q3 2026 results as FDA panel backs Galleri approval

GRAIL, Inc. said an FDA advisory panel, the Molecular and Clinical Genetics Panel of the Medical Device Advisory Committee, voted in favor of approval of the Galleri test in September¹. The company said it anticipates an FDA decision by early Q1 2027¹.

GRAIL also pointed to new published data backing the test. The company said it released findings from the NHS-Galleri trial in The New England Journal of Medicine and Nature Medicine, along with final results from the PATHFINDER 2 study in Nature Medicine¹. Those papers covered clinical utility, test performance and safety data drawn from roughly 175,000 participants across the UK and North America¹. GRAIL said the studies showed 4 to 6.5 times more cancers detected, with a favorable safety profile and consistent performance across the two trials¹. In the NHS-Galleri trial specifically, the company reported a reduction of more than 20% in Stage IV diagnoses among 12 prespecified aggressive cancers and a 25% drop in cancers diagnosed after emergency presentation, compared with the control arm¹. The company also said adding Galleri to standard-of-care screening found more Stage I-II cancers in the trial than the UK's national screening program found across all stages¹.

On commercial performance, GRAIL said Galleri test volume for the third quarter grew approximately 24% year-over-year to more than 56,000 tests¹, while Galleri revenue for the quarter grew 14% year-over-year to $37.3 million, with total revenue up 4% to $37.5 million¹.

GRAIL reported cash, cash equivalents and short-term marketable securities totaling $788.7 million as of September 30, 2026¹, and a net loss for the third quarter of $103.6 million¹.