D-Wave Quantum falls nearly 3% as earnings miss overshadows revenue beat
MENLO PARK, Calif. - GRAIL, Inc. (NASDAQ:GRAL), a $1.51 billion market cap biotechnology company, announced positive top-line results from its PATHFINDER 2 study evaluating the Galleri multi-cancer early detection test in over 25,000 participants aged 50 and older. The company has shown strong momentum, with shares surging over 132% in the past six months.
According to the company’s press release, the study showed that adding Galleri to standard cancer screening substantially increased cancer detection rates compared to the previously published PATHFINDER study. The test demonstrated a higher positive predictive value (PPV) than in the earlier study, while maintaining consistent cancer signal origin accuracy and specificity.
No serious safety concerns were reported in the trial, which began in 2021 and enrolled 35,878 adults with no clinical suspicion of cancer.
"We are delighted to see very encouraging performance of the Galleri MCED test as a cancer screening tool in broad intended use populations," said Josh Ofman, President at GRAIL.
The company plans to submit the PATHFINDER 2 results to the U.S. Food and Drug Administration (FDA) as part of its premarket approval application for Galleri, which has received Breakthrough Device Designation. GRAIL expects to complete the modular submission in the first half of 2026.
Detailed results from the study will be presented at an international oncology meeting later this year.
The Galleri test uses next-generation sequencing technology to detect DNA shed by cancer cells in blood samples, potentially identifying multiple cancer types before symptoms appear. The test is intended for adults with elevated cancer risk, particularly those 50 and older, and should be used alongside standard cancer screening methods.
In other recent news, GRAIL, Inc. reported its Q1 2025 earnings, revealing a 19% year-over-year increase in revenue, totaling $31.8 million. Despite exceeding earnings per share expectations with a result of -$3.10 compared to the forecast of -$4.26, the company continues to face challenges with a net loss of $106.2 million. Additionally, Canaccord Genuity raised its price target for GRAIL to $43, maintaining a Buy rating, citing the company’s growth potential in the multi-cancer early detection market. However, a report by Ningi Research labeled GRAIL as a short, highlighting regulatory challenges and operational issues that could impact its financial health. The report questions the commercial viability of GRAIL’s Galleri test, noting its lack of FDA approval and insurance coverage, which may hinder reimbursement opportunities. Meanwhile, GRAIL’s stockholders recently elected a new director and ratified Ernst & Young LLP as the company’s independent auditor. These developments reflect ongoing investor interest and scrutiny as GRAIL navigates the competitive cancer screening market.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.