LOGO
LOGO

Biotech Daily Dose

GRAIL's NHS-Galleri Trial Falls Short Of Primary Endpoint In Multi-Cancer Screening, Shares Slide

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

Shares of GRAIL, Inc. (GRAL) are down nearly 48% today after the company reported that its highly anticipated NHS- Galleri trial failed to meet its primary endpoint, despite showing encouraging outcomes in cancer detection.

The NHS-Galleri trial, one of the largest multi-cancer early detection studies ever conducted, enrolled more than 142,000 participants in partnership with England's National Health Service. The trial aims to see if using the Galleri blood test alongside existing cancer screening can help to find cancer early.

According to the trial findings, the trial, which evaluated multi-cancer screening with the Galleri test over three years, did not show a statistically significant reduction in Stage III-IV cancers. However, a favorable trend toward fewer late-stage cancers was observed in a pre-specified group of 12 high-risk cancers in the screening arm after the initial screening round, according to the company.

Full results are expected to be presented later in 2026, alongside data from the PATHFINDER 2 study.

Financial Results

Alongside the clinical update, GRAIL reported its fourth-quarter and full-year 2025 financial results.

For the fourth quarter, revenue rose 14% year-over-year to $43.6 million, driven by a 31% increase in U.S Galleri test sales to $41.3 million.

Net loss widened to $99.2 million in Q4, 2025, from $97 million in Q4, 2024.

For the full year 2025, revenue climbed 17% to $147.2 million compared to $125.5 million year ago, with U.S. Galleri revenue up 26% to $136.8 million.

Net loss narrowed significantly to $408.4 million, compared to $2.02 billion from the year ago, reflecting $138.3 million in amortization and $28.0 million in intangible asset impairment.

The company ended the year with $904.4 million in cash, providing runway into 2030.

Despite the trial setback, GRAIL emphasized several strategic milestones. The company completed its Premarket Approval submission to the U.S. FDA in January 2026, supported by data from PATHFINDER 2 and the first year of the NHS-Galleri trial.

Commercial adoption continued to expand, with more than 185,000 Galleri tests sold in 2025 through partnerships with Hims & Hers, Functional Health, and Everlywell.

In a significant policy development, the Medicare Multi-Cancer Early Detection Screening Coverage Act was signed into law, establishing a pathway for reimbursement of Galleri testing.

GRAL has traded between $20.44 and $118.84 over the past year. The stock is currently trading at $52, down 48%.

For comments and feedback contact: editorial@rttnews.com

Business News

Global Economics Weekly Update -May 18 – May 22, 2026

May 22, 2026 14:46 ET
Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.

Latest Updates on COVID-19