GRAIL, Inc. GRAL

Nasdaq · oncology · unclear · EDGAR · Updated Nov 6, 2026

GRAIL, Inc. (Nasdaq: GRAL) is an oncology diagnostics company. Its next catalyst on record is Galleri: FDA PMA decision (Q1 2027).

Upcoming catalysts

No catalyst is dated to the next 30 days or to an FDA action date.

Next further out: Galleri — FDA PMA decision (Q1 2027). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.

Program	Indication	Modality	Stage
Galleri	multi-cancer early detection screening	unclear	NA_NON_THERAPEUTIC

Sep 30, 2026
adcomm positive FDA Advisory Committee voted in favor of approval of GRAIL's Galleri Multi-Cancer Early Detection Test in September 2026.Announced a favorable vote for approval of the Galleri test from the FDA's Molecular and Clinical Genetics Panel of the Medical Device Advisory Committee (the 'Advisory Committee') in September. Filing
Feb 19, 2026
missed Randomized NHS-Galleri trial (142,000 participants) did not meet its primary endpoint of a statistically significant reduction in Stage III-IV cancers, though Stage IV diagnoses fell by more than 20% in rounds two and three and cancer detection rate rose four-fold.The primary endpoint of statistically significant Stage III-IV reduction was not observed. Filing
Jan 1, 2026
submitted GRAIL completed submission of the final module of the Galleri PMA application to FDA in January 2026.Completed submission of the final module of the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Galleri in January. Filing

Cash runway against each catalyst, with the company's own runway statement
Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
Expected move for each dated catalyst, from comparable past events
Phase 2 evidence behind each Phase 3 readout
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