GRAIL reports news on its healthcare business focused on early cancer detection through the Galleri multi-cancer early detection blood test. The company uses next-generation sequencing, population-scale clinical studies, machine learning, software and automation within a targeted methylation-based platform designed to detect and identify multiple cancer types in earlier stages.
Recurring updates include Galleri revenue and test-volume trends, clinical data from programs such as NHS-Galleri and PATHFINDER 2, regulatory and evidence-generation activity, health-system access initiatives, commercial partnerships, conference presentations, equity incentive grants and governance changes. Company announcements also describe how its platform may support screening and precision oncology uses, including risk stratification, minimal residual disease detection, biomarker subtyping, treatment monitoring and recurrence monitoring.
GRAIL (Nasdaq: GRAL) reported third-quarter 2026 revenue of $37.5 million, up 4% year over year, alongside a wider net loss. Galleri revenue rose 14% to $37.3 million, with test volume up approximately 24% to more than 56,000. Net loss increased 16% to $103.6 million, while gross loss widened 32% to $18.1 million. Non-GAAP adjusted gross profit fell 20% to $15.9 million, and adjusted EBITDA loss widened 29% to $92.6 million.
An FDA advisory committee voted in favor of Galleri approval; GRAIL anticipates an FDA decision by early Q1 2027. Galleri is not yet FDA-approved. Published NHS-Galleri results showed a reduction of >20% in Stage IV diagnoses of 12 prespecified aggressive cancers and a 25% reduction in cancers diagnosed after emergency presentation in the Galleri arm versus control. Nine-month Galleri revenue grew 24% to $119.7 million, with volume up 36% to more than 174,000 tests.
GRAIL (GRAL) management will present at the UBS Global Healthcare Conference on November 10, 2026, in Palm Beach, Florida. The presentation is scheduled for 11:00 a.m. ET. A live and replay webcast will be accessible at investors.grail.com, with the replay available for at least 30 days after the event.
GRAIL (Nasdaq: GRAL) will release its third-quarter 2026 financial results after the market closes on Nov. 4, 2026.
Management will host a webcast and conference call at 1:30 p.m. PT / 4:30 p.m. ET to discuss results and business progress. The live webcast and recorded replay will be available at investors.grail.com and open to all interested parties.
GRAIL (GRAL) will present additional NHS-Galleri and PATHFINDER 2 study data at two cancer conferences in October 2026.
The company plans six abstracts at the Early Detection of Cancer Conference in Edinburgh, October 6–8, and two abstracts at the ESMO Congress in Madrid, October 23–27. Topics include diagnostic workups following multi-cancer early detection testing, detection across cancer types, performance across racial and ethnic groups, and annual screening. The ESMO rapid oral presentation on PATHFINDER 2 diagnostic workups is scheduled for October 26.
GRAIL (GRAL) received a favorable FDA advisory panel vote on its Galleri cancer-screening test on September 23, 2026.
The panel voted 7–2, with one abstention, that Galleri’s benefits outweigh its risks for screening adults aged 50 and older for multiple cancers. It voted unanimously in support of safety and 6–4 in support of effectiveness. The votes are recommendations, not FDA approval. The agency is not bound by them and is expected to decide on Galleri’s premarket approval application in the coming months.
Galleri is intended to supplement, not replace, recommended screenings. It is designed to detect cancer-specific methylation patterns and predict where a detected cancer signal originated. In clinical studies, Galleri detected approximately four to seven times more cancers than standard care alone; most Galleri-detected cancers were found at earlier stages. GRAIL submitted its application on January 29, 2026. The FDA designated Galleri a Breakthrough Device in 2018.
GRAIL (GRAL) granted employment inducement restricted stock units to new non-executive employees under Nasdaq Listing Rule 5635(c)(4), as of September 3, 2026.
The awards cover an aggregate of 55,867 RSUs tied to GRAIL common stock, issued to 59 recently hired non-executive employees as a material inducement to join the company. The RSUs were granted under GRAIL's Inducement Equity Incentive Plan and its standard restricted stock award agreement. The plan is used only for individuals who were not previously employed by GRAIL, or who return after a bona fide break in service. The RSUs vest over approximately four years, with 25% vesting on August 31, 2027 and the remaining portions vesting on each one-year anniversary thereafter, subject to continued employment with GRAIL or its affiliates.
GRAIL (Nasdaq: GRAL) announced that its management will present at the Morgan Stanley 24th Annual Global Healthcare Conference in New York on Monday, September 14, 2026, at 11:30 a.m. ET. A live and replay webcast will be available via the investor relations section of GRAIL's website for at least 30 days.
GRAIL (Nasdaq: GRAL) announced that the FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to meet on September 23, 2026 to review the Premarket Approval (PMA) application for its Galleri® multi-cancer early detection (MCED) blood test.
Galleri is designed to detect cancer-specific methylation patterns in blood, including cancers without existing screening, and to predict the cancer signal origin to guide diagnostic evaluation. According to GRAIL, the PMA focuses on test performance and safety data from 25,490 consented participants in the US-based PATHFINDER 2 study with one year of follow-up, and from more than 70,000 participants in the intervention arm of the first-year prevalent screening round of the NHS-Galleri randomized, controlled trial. Galleri was designated a Breakthrough Device by the FDA in 2018, and the submission also includes an analysis comparing earlier Galleri versions with the updated PMA version.
GRAIL (Nasdaq: GRAL) reported Q2 2026 total revenue of $44.7 million, up 26% year-over-year, driven by Galleri test revenue of $42.6 million, up 24%, on more than 61,000 tests, a 35% volume increase. First-half 2026 Galleri revenue reached $82.5 million with over 117,000 tests, rising 30% and 42% year-over-year, respectively.
Net loss for Q2 was $110.2 million, gross loss was $12.6 million, non-GAAP adjusted gross profit was $21.6 million, and adjusted EBITDA was $(90.3) million. Cash, cash equivalents and short-term marketable securities totaled $861.6 million, supported by a $110 million equity financing with Samsung entities.
GRAIL highlighted detailed NHS-Galleri and PATHFINDER 2 study results showing higher early-stage cancer detection and reduced late-stage diagnoses in certain cancers, expanded U.S. access through a Priority Health collaboration, and is anticipating an FDA advisory committee in the fall to review its Galleri PMA submission.
GRAIL (Nasdaq: GRAL) announced that company management will present at the Canaccord Genuity 46th Annual Growth Conference in Boston on Tuesday, August 11 at 10:00 a.m. ET. Live and replay webcasts of the presentation will be available through the investor relations section of GRAIL's website, with the replay archived for at least 30 days.