FDA Panel Schedules to Evaluate GRAIL Premarket Approval Application for Multi-Cancer Early Detection Test
The FDA's advisory committee will meet on September 23 to review the PMA application for GRAIL's Galleri multi-cancer early detection test.
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GRAIL, Inc. (NASDAQ:GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced that the U.S. Food and Drug Administration's (FDA) Molecular and Clinical Genetics Panel
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The FDA's advisory committee will meet on September 23 to review the PMA application for GRAIL's Galleri multi-cancer early detection test.
GRAIL (NASDAQ:GRAL) reported quarterly losses of $(2.56) per share which beat the analyst consensus estimate of $(2.62) by 1.92 percent. This is a 19.5 percent increase over losses of $(3.18) per share from the same
A class action lawsuit has been filed against GRAIL, Inc. alleging that the company provided materially false and misleading statements regarding its NHS Galleri trial results. The complaint claims GRAIL concealed that the trial period was insufficient to demonstrate a reduction in Stage III-IV cancers. On February 19, 2026, GRAIL announced that the primary endpoint was not achieved, causing the stock price to fall significantly. Investors who purchased shares between May 13, 2025, and February 19, 2026, have until August 4, 2026, to apply as lead plaintiff.