The test already has fast-growing commercial sales, and FDA approval would significantly increase them
The latest update sees management give upbear guidance for 2026 and confirm an FDA submission in the first quarter of 2026.
Shares in multi-cancer early detection (MCED) company, Grail (NASDAQ: GRAL), rose by more than 13% to 3 p.m. today. The move comes as optimism mounts over the company's prospects in 2026. An upbeat presentation at the recent JPMorgan Healthcare Conference fueled that positivity.
Grail's Galleri MCED test has been on the market for four years and has established commercial sales. I listened in on the JP Morgan presentation and the latest guidance update from the company's management calls for total 2025 revenue of $147 million to $148 million, of which Galleri is responsible for $136 million to $137 million.
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Turning to the 2026 guidance, management estimates Galleri revenue will grow by 22% to 32%. The company is doing a good job with cash burn, too, down to $274 million in 2025 from $579 million in 2024. With a cash position of $904 million (helped by private placements and $110 million in investment from Samsung) management believes it has a "runway into 2030", meaning that it has sufficient cash to run its operations until then, based on its current cash position.
That said, the real excitement about the stock stems from its planned premarket approval (PMA) submission to the Food and Drug Administration (FDA) in the first quarter. FDA approval would open up the test for medical and insurance coverage, as well as facilitate marketing efforts and physician acceptance and adoption.
Image source: Getty Images.
The submission will be backed by data from its Pathfinder 2 trial in the U.S. and a separate 140,000-person trial in the U.K. with the National Health Service – the results of which could lead to U.K. adoption of the test. All told, there's a lot to look forward to for Grail investors in 2026, and despite the usual risks around FDA approvals, the stock is attractive for enterprising investors.
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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.