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STAT+: Key study of Grail’s cancer detection test fails in setback for company

A blood test for detecting cancer early being developed by the diagnostics firm Grail failed to meet its main goal in a giant study being conducted with England’s National Health Service, the company said Thursday.

Grail’s test has been the standard bearer for new technologies that promise a blood test can be used to detect many different types of cancer early and eventually even to indicate to scientists where in the body to look for tumors. The company already sells its test, called Galleri, for a list price of $1,000, although it is not yet approved by the Food and Drug Administration. Grail said Thursday it sold 185,000 tests in 2025, generating $136.8 million. 

The company’s shares were down 47% in after-hours trading.

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© Adobe

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STAT+: On Day 2 of JPM, Gilead lays outs it next test, a VC looks to raise funds, and one firm has FDA whiplash

This is the online version of The Readout, STAT’s flagship biotech newsletter. Sign up to get it in your inbox.

You’re back. We’re sort of back. It’s Day 2 of JPM and we’re definitely not exhausted or delirious yet.

This is Elaine Chen, Adam Feuerstein, Matt Herper, and Allison DeAngelis again. We’ve got a lot more news today, so let’s get to it.

The next test for Kite Pharma — and Gilead

It’s anito-cel, the CAR-T therapy for multiple myeloma that Gilead is developing in partnership with Arcellx. Gilead submitted the therapy to the FDA sometime before the end of December, Cindy Perettie, executive vice president of Kite Pharma, the cell therapy division of Gilead, told STAT at a Gilead media breakfast.

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© Alex Hogan/STAT

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STAT+: Moderna says key study of its CMV vaccine, expected to be its next big win, failed

Moderna said Wednesday afternoon that its experimental vaccine for cytomegalovirus, a cause of disability in newborns, failed in a Phase 3 trial, a significant setback for a company already facing pressure from Wall Street and the federal government.

The CMV vaccine had been the company’s lead program prior to the Covid-19 pandemic. Leadership had repeatedly said it could bring in between $2 billion and $5 billion in peak annual sales. Analysts polled by Visible Alpha forecast peak sales of $1.6 billion for the product.

“It’s obviously disappointing,” said Stephen Hoge, Moderna’s president, in an interview.

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© Ruby Wallau for STAT

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