Grail Shares Fall 50% After NHS-Galleri Trial Misses Primary Endpoint

Shares of Grail (NASDAQ: GRAL) declined sharply (-50%) Friday after the company reported that its NHS-Galleri trial did not achieve its primary endpoint of a statistically significant reduction in combined Stage III and Stage IV cancer diagnoses.

The study, conducted within England’s National Health Service, was designed to demonstrate a measurable decline in late-stage cancers among participants receiving the Galleri multi-cancer early detection test. The company said the primary endpoint was not observed. It reported, however, a favorable trend toward fewer Stage III and Stage IV cancers within a pre-specified group of 12 high-mortality cancers following the initial screening round.

By early afternoon trading, shares had fallen more than 50%, reducing the company’s market capitalization to approximately $2.1 billion.

Alongside the clinical update, the company reported fourth-quarter results. Net loss for the period totaled $99.2 million, or $2.44 per share, narrower than the consensus estimate of a $4.01 per share loss. Revenue rose 14% year over year to $43.6 million. For the full fiscal year 2025, more than 185,000 Galleri tests were sold. U.S. Galleri revenue increased 26% to $136.8 million, supported in part by partnerships with digital health platforms including Hims & Hers Health.

At year end, the company reported $904.4 million in cash, cash equivalents, and short-term marketable securities. Lease liabilities totaled $54.9 million, leaving the company with substantial net cash. Management said its liquidity is expected to fund operations into 2030.

Grail Chief Executive Officer Bob Ragusa said the company continues to see momentum in multi-cancer early detection and noted that adding the Galleri test to standard screening resulted in a four-fold improvement in overall cancer detection compared with standard screening alone.The company completed its final modular submission for Premarket Approval to the U.S. Food and Drug Administration in January. Detailed findings from both the NHS-Galleri study and the 35,000-participant PATHFINDER 2 trial are expected to be presented in mid-2026.

Grail also plans to expand its U.S. sales force and medical teams to support commercial growth and broader integration into health systems. Management intends to extend follow-up in the NHS-Galleri trial by six to 12 months to further assess the potential impact on late-stage cancer diagnoses.

About Grail

Grail (NASDAQ: GRAL) was founded in 2015 and is headquartered in Menlo Park, California. The biotechnology company focuses on multi-cancer early detection through blood-based tests, including its Galleri test designed to identify cancer signals across multiple tumor types. The company is advancing clinical studies and regulatory submissions to support broader commercial access in the United States and internationally.

At the time of publishing, Stocks.News does not hold positions in companies mentioened in the article.