Grail Shares Gain as FDA Panel Votes to Support Cancer Detection Test

By Elias Schisgall

Shares of Grail rose after the healthcare company said a U.S. regulatory committee voted to approve its Galleri multi-cancer early detection test.

The stock was up 5.6% at $114.59 as of midday Thursday. Shares have risen 34% this year.

The company on Wednesday said a panel on the Food and Drug Administration's Medical Devices Advisory Committee voted to approve its premarket approval application for Galleri.

The panel voted seven to two with one abstention that the test's benefits outweigh its risks, six to four that the test was effective, and unanimously in support of its safety.

"Today's vote reinforces the strength of Galleri's clinical evidence. We believe the panel's recommendations reaffirm a high evidence bar that GRAIL has set for a multi-cancer early detection test," Grail Chief Executive Josh Ofman said. "GRAIL is committed to working with the FDA as it completes its review of Galleri, the first PMA submission for a multi-cancer early detection test."

Galleri received a breakthrough devices designation from the FDA in 2018. The company submitted its PMA application to the FDA early this year, and the agency is expected to make a final decision in the coming months.

Write to Elias Schisgall at elias.schisgall@wsj.com

(END) Dow Jones Newswires

September 24, 2026 12:37 ET (16:37 GMT)