A securities class action has been filed against Grail, Inc. (GRAL) on behalf of all investors who purchased or otherwise acquired Grail common stock between May 13, 2025 through February 19, 2026. This case has been filed in the USDC – NDCA.
The complaint alleges Grail provided investors with material information concerning the likelihood of success of Grail’s NHS-Galleri trial achieving its primary endpoint of a statistically significant reduction in Stage III & IV cancers. Defendants’ statements included, among other things, confidence in the success of Galleri, consistently promoting its effectiveness “in the real world” and the positive predictive value (“PPV”) observed in the Pathfinder studies and in NHS-Galleri’s top-line results as sources of confidence for its potential. Defendants further routinely touted the design of the NHS-Galleri and how three years were necessary to demonstrate the achievability of the primary endpoint.
Grail provided these overwhelmingly positive statements to investors while, at the same time, disseminating materially false and misleading statements and/or concealing material adverse facts concerning the true state of Grail’s NHS-Galleri trial following the reveal of the top-line results covering the first screening round. Notably, as Grail have since attested, the trial as executed within the three-year follow-up period was insufficient to demonstrate the achievability of a reduction in Stage III-IV cancers; Grail disclosed the trial period, and thus the screening duration, was apparently insufficient to demonstrate whether the primary endpoint was achievable. Grail further repeatedly refused to provide detailed top-line results or other data from the NHS-Galleri study, potentially concealing known trendlines which arguably suggested either a longer timeline would be necessary or otherwise that the probability of achieving the statistical reduction in Stage III & IV cancers by the trial’s end had been reduced.
On February 19, 2026, Grail announced that the “primary endpoint of statistically significant Stage III-IV reduction was not observed” in the NHS-Galleri Trial. The Company attributed this shortcoming, in part, on “probably need[ing] a longer follow-up time to be able to [compare the study arms] adequately.”
Investors and analysts reacted immediately to Grail’s revelation. The price of Grail’s common stock declined dramatically. From a closing market price of $101.53 per share on February 19, 2026, Grail’s stock price fell to $50.21 per share on February 20, 2026, a decline of about 50.55% in the span of just a single day.