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GRAIL's Galleri Multi-Cancer Test Shows Strong Performance in PATHFINDER 2 Study, Paves Way for FDA Submission

By Maham Fatima | July 14, 2025, 11:11 AM

GRAIL Inc. (NASDAQ:GRAL) is one of the best young stocks to buy and hold for 5 years. On June 18, GRAIL announced positive top-line performance and safety results from the pre-specified analysis of the first 25,578 participants in its registrational PATHFINDER 2 study. This study was initiated in 2021 and is evaluating the safety and performance of the Galleri multi-cancer early detection/MCED test when used in addition to standard-of-care single cancer screening.

The study involves 35,878 adults over 50 years of age with no clinical suspicion of cancer. The results from PATHFINDER 2 indicate substantially greater additional cancer detection compared to the previously published PATHFINDER study, where adding Galleri more than doubled the overall number of cancers detected by screening.

GRAIL's Galleri Multi-Cancer Test Shows Strong Performance in PATHFINDER 2 Study, Paves Way for FDA Submission
A scientist in the lab, researching the development of biopharmaceutical monoclonal antibody drugs.

Importantly, no serious safety concerns were reported in PATHFINDER 2. Detailed PATHFINDER 2 data are expected to be presented at a medical congress later this year. GRAIL plans to submit the PATHFINDER 2 study results to the US FDA as part of the Galleri premarket approval application/PMA.

GRAIL Inc. (NASDAQ:GRAL) is a commercial-stage healthcare company that provides multi-cancer early detection testing and services in the US and internationally.

While we acknowledge the potential of GRAL as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you’re looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock.

READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now.

Disclosure: None. This article is originally published at Insider Monkey.

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