NasdaqGS:GRALBiotechs
GRAIL (GRAL) Is Down 6.5% After FDA Sets Galleri PMA Panel Review – Has The Bull Case Changed?
GRAIL announced that the FDA’s Molecular and Clinical Genetics Panel will meet on September 23, 2026, to review the Premarket Approval application for its Galleri multi-cancer early detection blood test, which targets cancer-specific methylation patterns and is intended to complement existing screening methods.
This review marks a major regulatory inflection point for what GRAIL describes as the only multi-cancer early detection test backed by large interventional and randomized, controlled...