Here's Why Grail Shares Popped Higher This Week
Key Points
Sales volumes of its multi-cancer early detection test, Galleri, continue to grow strongly.
The company continues to work toward FDA approval of Galleri, and detailed trial results are expected soon.
There is no guarantee that Grail will have good news at the ASCO meeting, and investors should be aware of the risks involved in buying the stock.
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Grail (NASDAQ: GRAL) shares rose 14% this week as the market warmed to the company's first-quarter earnings report and commentary ahead of its presentation at the American Society of Clinical Oncology (ASCO) meeting.
Grail's difficult 2026
Despite the recent rise, the stock is down almost 28% this year, largely due to the disappointing results from its 3-year trial with England's National Health Service (NHS) involving a 142,000 demographic. The trial's primary endpoint was a statistically significant reduction in late-stage cancers (Stages III and IV) among patients who used Galleri, its multi-cancer early detection (MCED) test.
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Unfortunately, the primary endpoint wasn't observed, and the stock crashed in February. The market is worried that the trial results may mean Grail won't receive Food and Drug Administration (FDA) approval, and even if it does, there's the question of insurers' willingness to cover Galleri.
Why the stock is on the comeback trail
With the negatives out of the way, it's important to understand that the aim of the trial was to detect cancers early (Stages I and II), thereby reducing the detection of late-stage cancers compared to the control group.
The good news is the trial resulted in a "Substantial increase in the absolute number of Stage I-II cancers in the 12 pre-specified deadly cancer types that are typically found in late stages were observed in the intervention arm," according to the release details in February. The bad news is "there was a higher than anticipated incidence of Stage III cancers."
As such, management is extending the trial's follow-up period by 6-12 months , and it's possible that, sadly, cancers might develop in the control group, which will prove out Galleri.
Image source: Getty Images.
What changed this week
While there's no guarantee this will happen, the recent results demonstrate that customers remain positive about Galleri, with test volume beating expectations and growing by 50% year-over-year, leading to overall company revenue growth of 28% in the first quarter.
Moreover, the company continues to seek FDA approval for Galleri and will present detailed trial results at the ASCO meeting in late May. The data presented could be pivotal in garnering market acceptance. Something for investors to look out for.
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Lee Samaha has no position in any of the stocks mentioned. The Motley Fool recommends Grail. The Motley Fool has a disclosure policy.
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