BUZZ - FDA raises no major concerns about cancer detection, Grail shares surge
路透社2026/09/21 15:56September 21 - ** 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
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