On September 28, GRAIL, Inc. rose 5.69% in regular trading, trading at $130.05 per share, with turnover of $17.95 million. The stock extended its recent uptrend following a landmark vote by the FDA advisory committee in support of its Galleri multi-cancer early detection blood test.

The FDA Molecular and Clinical Genetics Devices Panel voted unanimously (10-0) to approve Galleri's safety profile, six-to-four in favor of its efficacy, and seven-to-two with one abstention on the benefit-risk assessment for detecting multiple cancers in adults aged 50 and older. The vote marks a critical milestone for what would be the first-ever multi-cancer early detection product to receive FDA premarket approval.

Galleri uses AI to analyze cell-free DNA methylation patterns in a single blood draw, screening for signals across more than 50 cancer types. Key data from the PATHFINDER 2 study showed a 6.5-fold increase in cancer detection when combined with standard screening, with specificity of 99.6%. While the NHS-Galleri trial missed its primary endpoint, Stage IV cancer diagnoses were notably reduced. Formal FDA approval is expected in the first half of next year. UBS maintains a buy rating with a $105 price target, while RBC has an $84 target.

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