Shares of Grail (NASDAQ:GRAL) plunged almost 47% in premarket trading on Friday after the company announced that its landmark NHS-Galleri study did not achieve its primary endpoint — a statistically significant drop in late-stage (Stage III and IV) cancer diagnoses.
Despite the clinical setback, the California-based biotech posted fourth-quarter results that exceeded expectations. The company reported a net loss of $99.2 million, or ($2.44) per share, markedly narrower than the consensus forecast of a ($4.01) loss. Revenue totaled $43.6 million for the quarter, up 14% year over year. However, the disappointment surrounding the trial data overshadowed the stronger-than-expected financial performance.
On the commercial front, adoption of the Galleri multi-cancer early detection test continued to expand. More than 185,000 tests were sold during fiscal 2025, while U.S. Galleri revenue climbed 26% annually to $136.8 million. Growth was supported in part by partnerships with digital health providers such as Hims & Hers.
Grail closed the year with $904.4 million in cash, cash equivalents and short-term marketable securities, providing what management described as funding visibility through 2030 as it works to broaden market access.
Chief Executive Officer Bob Ragusa pointed to the “building momentum” behind multi-cancer early detection testing, even though the study missed its main objective. He noted that incorporating Galleri alongside standard screening methods led to a fourfold increase in overall cancer detection compared with routine screening alone.
In January, Grail finalized its modular Premarket Approval (PMA) submission to the U.S. Food and Drug Administration, marking an important milestone toward full regulatory approval. Comprehensive findings from both the NHS-Galleri trial and the 35,000-patient PATHFINDER 2 study are slated for presentation in mid-2026.
The company intends to scale up its U.S. sales organization and clinical teams to meet rising demand and deepen integration of its testing platform within healthcare systems. Additionally, management plans to extend follow-up in the NHS-Galleri trial by six to twelve months to further assess effects on reducing advanced-stage cancers.
“Following strong stock momentum for Grail over the past six months driven by encouraging commercial and financing updates, investors had been eagerly awaiting the NHS-Galleri readout ahead of FDA approval and CMS coverage decisions. As a result, we aren’t surprised to see shares trading meaningfully lower,” Morgan Stanley analysts wrote in a research note.