GRAIL Reports 36% Galleri Volume Growth and $147M Revenue Despite Trial Endpoint Miss
Galleri test volume rose 36% to over 185,000 tests in 2025, generating $147.2 million in full-year revenue, while cash reserves totaled $904.4 million. The NHS-Galleri trial missed its primary endpoint yet demonstrated a fourfold increase in overall cancer detection and over 20% reduction in Stage IV diagnoses.
1. Commercial Performance and Financial Results
U.S. Galleri volume increased 36% to over 185,000 tests in 2025, driving full-year revenue of $147.2 million, up 17% year-over-year. Fourth quarter screening revenue reached $42.3 million out of total Q4 revenue of $43.6 million. Cash and equivalents stood at $904.4 million, extending runway into 2030.
2. NHS-Galleri Trial Outcomes
Top-line results from the randomized NHS-Galleri trial of more than 142,000 participants did not meet the primary endpoint of reducing combined Stage III and IV cancers but showed a fourfold increase in overall detection versus standard care. Sequential screening rounds two and three achieved over 20% reductions in Stage IV diagnoses with no serious safety concerns reported.
3. FDA Premarket Approval Submission
GRAIL completed its PMA submission to the FDA at the end of January, supported by data from the PATHFINDER 2 study and the NHS-Galleri prevalent screening round. The company expects a roughly 12-month review period and emphasized the submission’s focus on test performance and safety data.
4. Outlook and 2026 Guidance
Management reiterated 2026 guidance of 22%–32% sales growth with cash burn under $300 million, citing planned expansions in field sales, partnerships, and medical teams. Detailed NHS-Galleri data will be presented at ASCO in May, with extended follow-up analyses expected to strengthen observed stage-shift trends.