Grail shares rose 36.56% to $110.30 on Monday after FDA staff released an executive summary for Galleri, the company’s multi-cancer early-detection blood test, ahead of a Sept. 23 advisory committee meeting. Staff said Galleri increased cancer detection, identified most cancers at stages offering an opportunity for curative-intent treatment, and met prespecified criteria for specificity, episode sensitivity and cancer-signal-origin prediction accuracy. The document also described a favorable safety profile, including modest and temporary effects on anxiety, no device-related adverse events, a very low false-positive rate and no adverse effect on adherence to recommended screening. The Molecular and Clinical Genetics Panel will discuss, recommend and vote on GRAIL’s premarket approval application, though the FDA retains final authority. GRAIL reported a second-quarter loss of $2.56 per share and revenue of $44.687 million, exceeding analyst expectations of a $2.62 loss and $42.76 million in sales.