New York, Feb 20, 2026, 05:10 EST — Premarket
GRAIL Inc shares were down sharply in U.S. premarket trade on Friday after the cancer test maker reported mixed topline results from its flagship NHS-Galleri study. The Nasdaq-listed stock was last down 47.6% at $53.20, compared with a prior close of $101.53. (Public)
The reaction matters because the Galleri blood test sits at the center of Grail’s commercial story, and the NHS-Galleri readout is one of the few large, randomized datasets investors have been waiting on. A clean win would have helped the company’s pitch to doctors, payers and regulators; a miss on the main goal tends to bring the timeline back into view.
Galleri is already sold in the U.S. at a list price of about $1,000, but it is not approved by the Food and Drug Administration, STAT News reported. That leaves uptake and reimbursement tied to evidence — and to how comfortable insurers get with what the trial did, and did not, show. (STAT)
Grail said the NHS-Galleri trial, run in England’s National Health Service and enrolling about 142,000 people aged 50 to 77, did not meet its primary endpoint — its main target — of a statistically significant drop in combined Stage III and Stage IV cancers. Still, the company said adding Galleri to standard screening cut Stage IV diagnoses by more than 20% in the second and third rounds within a pre-specified group of 12 deadly cancers and delivered a four-fold improvement in overall cancer detection versus standard screening alone; it also reported no serious safety concerns and said it plans to extend follow-up by 6 to 12 months. Professor Charles Swanton, one of the trial’s chief investigators, said “the difference is between Stage III and Stage IV disease.” (PR Newswire)
More detail may not land for a while. The company said it plans to submit results for presentation at the 2026 American Society of Clinical Oncology annual meeting, scheduled for May 29-June 2 in Chicago. (ASCO)
On the numbers, Grail said fourth-quarter revenue rose 14% to $43.6 million while its net loss narrowed to $99.2 million. For full-year 2025, it reported revenue of $147.2 million and a net loss of $408.4 million, and said it ended 2025 with $904.4 million in cash, cash equivalents and short-term marketable securities. CEO Bob Ragusa said “2025 was a year of significant commercial growth for GRAIL,” and the company said it completed the final modular submission for a premarket approval application to the FDA in January. (PR Newswire)
Premarket approval, or PMA, is the route the company is taking to seek U.S. clearance for Galleri. Investors will be looking for any hint of how the agency might view a trial that missed its primary endpoint but showed fewer metastatic, Stage IV cancers — the cases with the bleakest outlook.
There is a straightforward downside case. The primary miss gives skeptics room to argue that earlier detection does not yet translate cleanly into a population-level reduction in advanced disease, and payers can stay cautious while the company keeps spending to build demand and gather follow-up.
The read-through also lands beyond Grail. Blood-based cancer screening is a crowded, watchful corner of diagnostics, and any stumble in one of the biggest trials can chill sentiment toward the broader “multi-cancer early detection” push.
Analyst commentary has been mixed even before the readout. TD Cowen initiated coverage of Grail on Feb. 19 with a Hold rating and a $114 price target, according to MT Newswires. (MarketScreener)
For traders, the next checkpoint is simpler: whether the slide holds after the opening bell at 9:30 a.m. EST. For longer-horizon investors, the market will keep circling the same dates — the FDA review clock, and the fuller NHS-Galleri dataset the company says it plans to take to ASCO in late May.
