NEW YORK, December 30, 2025, 15:32 ET — Regular session
- GRAIL shares fell about 3.3% in afternoon trading, extending a two-session pullback.
- A university press release highlighted PATHFINDER 2 data and reiterated a first-quarter 2026 FDA submission timeline for Galleri.
- Investors are looking ahead to management’s Jan. 12 presentation at the J.P. Morgan Healthcare Conference for updated targets.
GRAIL Inc shares were down 3.3% at $84.95 in afternoon trading on Tuesday, after earlier touching $84.77.
The early-cancer detection company is trying to turn Galleri — a multi-cancer early detection (MCED) blood test that screens for signals across many cancers from a single draw — into a mainstream part of care. In its most recent quarterly update, Grail said U.S. Galleri revenue rose 28% year-on-year to $32.6 million and test volumes increased 39%, while it anticipated completing a U.S. premarket approval filing in the first quarter of 2026. GRAIL
That regulatory step matters because it can shape how quickly insurers and large health systems embrace the test. Grail said this month that management will present at the J.P. Morgan Healthcare Conference on Jan. 12, a venue investors often use to gauge near-term commercial traction and milestones. GRAIL
An Oregon Health & Science University press release on Monday highlighted PATHFINDER 2 data presented earlier this year, saying Galleri increased the number of cancers found by more than seven-fold when added to standard screenings for breast, colorectal, cervical and lung cancers. The release put the test’s positive predictive value — how often a positive result is a true cancer — at 62% and cited a false-positive rate of 0.4%; it also said data will be submitted to the FDA as part of a premarket approval (PMA) application in the first quarter of 2026, with a potential decision expected in 2027. “We are honored to partner with OHSU in the development of clinical evidence for our MCED program,” said Eric Fung, Grail’s senior vice president of clinical development, according to the release. Science X
The slide in GRAIL came as the biotech group eased, with the SPDR S&P Biotech ETF down 1.6% and the iShares Nasdaq Biotechnology ETF off 1.2%. Guardant Health fell 0.4% while Natera was little changed and Exact Sciences was fractionally lower; Illumina, which previously owned Grail, fell about 1.1%.
Grail has fallen about 7.2% from Friday’s close of $91.59 after Monday’s 4.05% drop and Tuesday’s decline, according to StockAnalysis data. The stock has traded as high as $113.80 over the past month, underscoring how quickly sentiment can swing around the name. StockAnalysis
Wall Street coverage remains limited, but the three analysts tracked by StockAnalysis show a consensus “strong buy” and an average price target of $105. Morgan Stanley analyst Tejas Savant is listed as maintaining a hold rating, with a $110 target. StockAnalysis
Grail began trading in 2024 after being spun out of Illumina following regulators’ pushback on Illumina’s deal for the company; Illumina retained a minority stake after the separation, Reuters reported. Reuters
For investors, the debate is simple to state and hard to solve: can multi-cancer blood screening move from early adopters into routine medicine without triggering costly follow-up testing from false alarms. Evidence that the test changes outcomes — and how payers treat that evidence — remains a major swing factor for the shares.
Traders are now watching for any fresh detail on the contents and timing of the FDA filing, and for management commentary at the Jan. 12 conference appearance. Any new disclosure on adoption, pricing, and how physicians use the test alongside standard screenings is likely to set the tone into early 2026.
Competition in blood-based cancer testing keeps pressure on expectations, and the group often trades more on trial updates and reimbursement signals than on near-term profitability. That dynamic can amplify moves when markets thin out around year-end.
