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BUZZ - FDA raises no major concerns about cancer detection, Grail shares surge

BUZZ - FDA raises no major concerns about cancer detection, Grail shares surge

路透社路透社2026/09/21 15:56
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- ** Cancer detection company Grail (GRAL.O) shares surged 34.6% to $108.71, reaching a seven-month high

** The US Food and Drug Administration (FDA) released briefing documents showing that Grail’s Galleri multi-cancer screening test has no significant safety or technical issues

** FDA panel discussion mainly focused on the product labeling and whether the existing data is sufficient to support a clear “early detection” claim

** RBC Capital Markets analysts stated that these documents “are positive for Galleri's approval prospects,” as concerns “mainly center around labeling issues, not the core test’s effectiveness and safety”

** Brokerage Piper Sandler believes this development is “favorable for GRAL,” and expects a “yes vote” will be obtained

** The Galleri blood test can screen for biomarkers from more than 50 types of cancer and supplements current single-cancer screening methods

** The FDA advisory committee is scheduled to meet on Wednesday

** As of the previous trading day’s close, the stock was up 24.45% year-to-date



(To assist readers whose native language is not English, Reuters has automatically translated its report into several other languages. As automated translation may contain inaccuracies or fail to capture desired context, Reuters does not guarantee the accuracy of these translations. They are provided solely for reader convenience. Reuters accepts no liability for any harm or loss arising from the use of the automated translation service.)

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