Home / Business and Economy / Grail Cancer Test Trial Misses Key Goal
Grail Cancer Test Trial Misses Key Goal
20 Feb
Summary
- Grail's shares dropped nearly 50% after a trial failed.
- The three-year cancer screening trial did not meet its primary goal.
- The Galleri test's success is crucial for potential Medicare coverage.
Grail (GRAL.O) experienced a significant stock decline, with shares falling nearly 50% in premarket trading on Friday, February 20, 2026. This sharp drop followed the news that the company's extensive three-year cancer screening trial had failed to achieve its main objective.
The trial, conducted across the National Health Service (NHS) with over 142,000 participants aged 50 to 77, was designed to assess if Grail's Galleri test could reduce late-stage cancer diagnoses and improve early detection. This data was intended to inform a potential screening program in England.
Grail announced after market close on Thursday, February 19, 2026, that the trial did not reach statistical significance for its primary endpoint. However, the company noted that a favorable trend was observed over time within the study.
This outcome presents a major blow to the blood test maker, especially as Grail had recently filed for U.S. regulatory approval of its Galleri test. The application utilized data from a smaller U.S. trial and the first year of the larger NHS trial.
Analysts suggest that while U.S. Food and Drug Administration (FDA) approval for Galleri may not be at material risk, the Centers for Medicare and Medicaid Services (CMS) will decide on coverage policies. CMS's decision might prioritize U.S.-based studies over the specific endpoints evaluated in the NHS trial. A recent U.S. law mandates insurance coverage for multi-cancer early detection tests under Medicare plans for older adults, set to begin in 2028.
