FDA Galleri briefing package lifts GRAIL 16% at open ahead of Wednesday panel

 

• FDA posted Galleri materials before the September 23 advisory-committee vote
• PATHFINDER 2 and NHS-Galleri specificity reached 99.85% and 99.74%, respectively
• Positive predictive values were 77.0% and 66.2%; origin accuracy exceeded 91%
• FDA reported no outstanding questions on study design, safety analysis, or assay concordance
• Agency still highlighted modest overall sensitivity of 35.0% and 31.6%
• Investors appeared to interpret the package as less negative than feared
• Shares opened near $92, approximately 13.9% above Friday’s $80.77 close
• Only 1.6% followed the opening gap, confirming a predominantly premarket reaction

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