NEW YORK, February 20, 2026, 12:32 EST — Regular session
Grail shares were down 49.5% at $51.26 in midday trading on Friday, after sliding as low as $45.51 earlier in the session. More than 10 million shares had changed hands by mid-day.
The selloff followed fresh readout from the company’s NHS-Galleri trial in England. Grail said the three-year study missed its primary endpoint — the main yardstick — of a statistically significant drop in combined stage III-IV cancers, but still showed fewer stage IV diagnoses and a four-fold higher cancer detection rate when Galleri was added to standard screening in a pre-specified group of 12 deadly cancers in about 142,000 people aged 50 to 77. The company said it plans to extend follow-up by 6 to 12 months and submit detailed results for presentation at ASCO; trial investigator Charles Swanton said he “see[s] how profound the difference is between Stage III and Stage IV disease,” while CEO Bob Ragusa said Grail is “expanding our field-based sales and medical teams.” (SEC)
That matters because the NHS study is both a credibility test and a commercial lever. In a separate release, Grail described Galleri as a blood test that can detect signals from more than 50 cancers, but said it still requires a prescription and has not been cleared or approved by the U.S. Food and Drug Administration. The company said it completed the final module of its premarket approval (PMA) application in January — “Our teams completed Galleri’s PMA submission to the FDA in January,” Ragusa said — and reported 2025 revenue of $147.2 million and $904.4 million in cash, cash equivalents and short-term marketable securities at year-end. (SEC)
Canaccord Genuity analyst Kyle Mikson said FDA approval does not look to be at material risk, but flagged uncertainty around coverage decisions. “We believe it is relatively likely that CMS will emphasize U.S.-based studies,” Mikson said, referring to the Centers for Medicare and Medicaid Services. Reuters also reported that President Donald Trump this month signed a bill allowing Medicare coverage of multi-cancer early detection tests starting in 2028, depending on age. (Reuters)
The endpoint language is technical, but the stakes are simple. A “primary endpoint” is the trial’s main result set up front, and missing it can make regulators and insurers more cautious even when secondary measures look better.
For screening tests, the key question is whether earlier detection changes outcomes, not just whether the test finds cancers. Stage IV disease typically means the cancer has spread; moving diagnoses earlier can open up more treatment options, but it also raises questions about follow-up testing and how fast patients get through the system.
The risk is that the NHS decides the data are not strong enough to support a national screening program, and U.S. payers take a wait-and-see stance. That could slow uptake even if the FDA review stays on track.
Traders will also be watching how quickly Grail can frame the miss — and whether more granular data support the company’s argument that stage-shift improves with repeated screening rounds. For now, the stock is trading like a binary event.
Next up is the ASCO annual meeting in Chicago, scheduled for May 29 through June 2, where oncology data often resets sentiment. Investors will also watch for any clearer signals on timing and scope of the FDA’s PMA review. (Asco)
