Particle.news

Grail Shares Plunge About 50% After NHS-Galleri Trial Misses Primary Endpoint

Grail highlights subgroup signals as its PMA undergoes FDA review.

Overview

  • The 142,000-plus person NHS-Galleri study in England did not show a statistically significant reduction in Stage III–IV cancers across the full cohort.
  • In a pre-specified set of 12 high-mortality cancers, Stage IV diagnoses fell by more than 20% in the second and third screening rounds.
  • Adding the Galleri blood test to standard care reduced cancers first detected through emergency presentation, which are typically diagnosed later.
  • First-year NHS data were included in Grail’s January premarket approval filing, and the company plans to present detailed analyses at ASCO 2026.
  • Grail reported Q4 results of a $2.44 per-share loss and $43.6 million in revenue and said it is expanding field-based sales and medical teams.