FDA Briefing Doc Backs Galleri Cancer Test, GRAIL Soars 34%
GRAL has more than doubled off its 52-week low of $39.295 on elevated volume (2.9× avg).
Summary
FDA scientists released a briefing document ahead of the Sept. 23 advisory committee meeting that is broadly positive on Galleri, GRAIL's multi-cancer early detection blood test. The document highlights the test's potential to improve outcomes and notes strong specificity (99.85% in PATHFINDER 2, 99.74% in NHS-Galleri) with low false positive rates. Shares jumped ~34% on the news, reflecting a major shift in regulatory sentiment after February's NHS-Galleri trial miss. The panel will vote on safety, effectiveness, and benefit-risk on Sept. 23; CEO Joshua Ofman has guided for potential approval in the first part of 2027. This is a pivotal regulatory catalyst for GRAIL, whose $4.8B market cap hinges on Galleri's commercial viability.
At the time of this announcement, GRAL was trading at $107.76 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $4.8B. The 52-week trading range was $39.30 to $118.84. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: Seeking Alpha.