Grail has best day in over 18 months on positive regulatory news for cancer test

Shares of mid-cap cancer test maker Grail added more than a third on Monday, posting their best performance since February 2025. The rally came after the U.S. Food and Drug Administration released documents suggesting it had no major concerns about approving the company’s test for detecting multiple types of cancer. The findings were more favorable than investors had expected, writes the Wall Street Journal.

Grail jumped almost 34% on Monday to $108.00 per share. It was the stock’s best performance since February 2025, according to Stocktwits. The FDA’s briefing documents, prepared for a Wednesday advisory committee meeting on Grail’s test for screening for multiple types of cancer, were more favorable than expected.

All cancer-screening methods recommended in the U.S. target a single type of cancer, while Grail states that its Galleri blood test can detect more than 50 types of cancer in people aged 50 and older. However, clinical trial data released in February showed that the test failed to meet its primary endpoint of a statistically significant reduction in combined stage III-IV cancer diagnoses. The news caused Grail stock to lose half its value in a single day.

The test also performs poorly at detecting early-stage cancers, identifying them in 20-30% of cases, Scott Ramsey, director of the Hutchinson Institute for Cancer Outcomes Research at Fred Hutchinson Cancer Center in Seattle, told the Wall Street Journal in March. “When the performance is that poor, it’s missing more cancer than it’s finding, particularly at an early stage,” he said.

The FDA findings released Monday indicate that regulators had no outstanding questions about the test’s analytical performance, the design of the studies, or the main safety results, Stocktwits writes. The main questions the FDA put to the committee concern whether Galleri’s benefits outweigh its risks for patients and whether it should be described as an “early detection” test or only as a cancer-detection test.

The committee will vote on whether the test is safe and effective and whether its benefits outweigh its risks. Its recommendations are not binding, but a positive assessment would increase the chances of Galleri receiving approval, Stocktwits noted.

Grail has sold Galleri since 2021. U.S. law allows the company to offer it without FDA approval, but only as a laboratory-developed test ordered by a healthcare provider and paid for out of pocket by the patient. FDA approval would make Galleri eligible for coverage under the government insurance program Medicare, which will begin covering such tests in 2028.

Grail has gained 26% year to date, including Monday’s rally. Wall Street nevertheless remains cautious on the stock, according to MarketWatch data. It has six “hold” ratings versus five “buy” calls. The average target price of $82.40 per share implies almost 24% downside from the last close.