Sometimes in biotech, the headline is everything. For GRAIL Inc. (GRAL), the headline on Friday was brutal: its shares cratered by nearly 48% in premarket trading. The culprit? Results from a huge, closely-watched trial for its flagship product, the Galleri multi-cancer early detection test.
Think of Galleri as a proactive scout. With just a blood draw, it's designed to screen for over 50 types of cancer before symptoms even show up. The idea is revolutionary—catch cancer early, save lives. But the latest data from a massive real-world study in England, called the NHS-Galleri trial, delivered a gut punch: it didn't meet its primary goal.
What's interesting is the stock's nosedive happened while the broader market was having a perfectly nice day, with the Nasdaq and S&P 500 both up. This wasn't a market-wide panic; this was a company-specific reckoning.
The Trial Data: A Miss With Silver Linings
Let's unpack the trial results, released Thursday. The primary endpoint wasn't met. In the high-stakes world of clinical trials, that's the official scoreboard, and GRAIL came up short. That failure was enough for Johnson Fistel, a law firm, to announce it's investigating whether GRAIL's executives complied with federal securities laws in their disclosures to investors.
But here's where it gets nuanced. The trial, which followed 142,000 people in England's National Health Service for three years, did show some genuinely encouraging trends. Adding the Galleri test to standard cancer screening led to a "substantial and clinically meaningful" drop in diagnoses of Stage IV—the latest and most serious stage—across a group of 12 deadly cancers. The reduction in these late-stage diagnoses got better each year, exceeding 20% in the second and third rounds of screening.
Even more striking: when Galleri was added to standard care, the overall cancer detection rate for common cancers like breast and colorectal was four times better than with standard screening alone in England. For a test aiming to find cancer early, that's a powerful signal.
The big question mark now swings to the U.S. The company's application for premarket approval from the FDA is still pending. GRAIL also said it finished analyzing its PATHFINDER 2 study, with results consistent with earlier data, and plans to expand its U.S. sales team based on the combined trial results. The detailed data from both big studies won't be shared until mid-2026.
Earnings Were Fine, But Nobody Cares Right Now
In another universe, GRAIL's quarterly earnings might have been the story. The company reported a loss of $2.44 per share, which was better than the $2.73 loss analysts expected. Revenue of $43.597 million was essentially right on target with estimates of $43.600 million.
But when your groundbreaking trial misses its main objective, beating earnings estimates by a few cents feels like rearranging deck chairs on the Titanic. The market's focus is squarely on the clinical data.












