SQUAWK/NEWS
Account
Theme
Account
Menu
Live News REGULATION FLASH L impact

BUZZ — Grail jumps as FDA raises no major concerns on cancer test

* Shares of cancer test maker Grail rise 34.6% to over seven-month high of $108.71 * U.S. FDA releases briefing documents showing no major safety or technical concerns regarding Grail's Galleri multi-cancer screening test * FDA focuses its panel discussion primarily on product labeling and whether data supports an explicit "early detection" claim * RBC Capital Markets analysts say the documents "read positively for Galleri's approval case" because questions center "mostly on labeling rather than core test validity and safety" * Brokerage Piper Sandler views the update as "constructive for GRAL" and expects "a favorable vote" * The Galleri blood test screens for signals across more than 50 cancers as a complement to existing single-cancer screening methods * The FDA's advisory committee is scheduled to meet on Wednesday * As of last close, stock up 24.45 YTD (Reporting by Kamal Choudhury in Bengaluru) ((mailto:Kamal.Choudhury@thomsonreuters.com;)

GRAL.O