Grail stock surges 55% after FDA panel backs Galleri cancer test

  • Grail stock rose 55% in one week after an FDA panel backed Galleri.
  • Kyle Mikson raised Grail’s price target from $80 to $150.
  • Grail filed for PMA in January, with an FDA decision expected within months.

Grail’s stock rose 55% in one week after an FDA advisory panel backed its Galleri multi-cancer early detection test as safe and beneficial. The recommendation advances the test toward premarket approval (PMA), although advisory-panel votes are not legally binding. Analyst Kyle Mikson raised his price target for Grail from $80 to $150. Galleri analyzes cancer-linked DNA methylation patterns to identify disease before symptoms appear and can detect cancers such as pancreatic, ovarian and esophageal cancer that lack established routine screening. The panel backed the test unanimously on safety, by 6-4 on effectiveness and by 7-2 on its benefit-risk profile, with one abstention, while members said it should supplement rather than replace existing screening. Grail filed for PMA in January, and the FDA is expected to decide within months. If approved, Galleri would become the first blood-based multi-cancer screening test authorized in the United States, according to Grail. The test is currently authorized only as a laboratory developed test, requiring consumers to pay its full $940 cost. PMA approval could open discussions over Medicare and private-insurer coverage and inclusion in screening guidelines. Galleri generated $136.8 million in U.S. revenue last year. Samsung Electronics and Samsung C&T invested $110 million in Grail.

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