
GRAIL Submits FDA PMA for Galleri Multi-Cancer Early Detection Test
GRAL submits final FDA PMA module for the Galleri MCED test, reaching a milestone in broader cancer screening and potential public health impacts.
Loading news...

GRAL submits final FDA PMA module for the Galleri MCED test, reaching a milestone in broader cancer screening and potential public health impacts.

FDA Submission Marks a Pivotal Milestone in Advancing Early Cancer Detection, Addressing Unmet Needs in Cancer Screening MENLO PARK, Calif., Jan. 29, 2026 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced the submission of the final module of the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Galleri® multi-cancer early detection (MCED) test.

SAN FRANCISCO, Jan. 26, 2026 (GLOBE NEWSWIRE) -- Surprisingly, a study of older adults is getting a lot of buzz among peak performance experts in the world of sports. The recent INHANCE neuroimaging study showed for the first time ever that there is an intervention that can upregulate the production of acetylcholine (the “pay attention” brain chemical) — known to downregulate with aging and to plummet in dementia. That intervention is brain exercises in the app BrainHQ from Posit Science. The study made headlines around the globe, garnering attention from experts who work in aging—quickly, and unexpectedly, followed by sports performance experts.

The test already has fast-growing commercial sales, and FDA approval would significantly increase them The latest update sees management give upbear guidance for 2026 and confirm an FDA submission in the first quarter of 2026. These 10 Stocks Could Mint the Next Wave of Millionaires ›

GRAIL (GRAL) offers MCED screening tests that offer employers economic value and employee health clarity. Divestiture of GRAIL by Illumina offers investors $8B valuation foundation. TAM valuation implies substantial upside, assuming eventual FDA approval and moderate market penetration.

GRAIL, Inc. (GRAL) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript

Cwm LLC lowered its stake in shares of GRAIL, Inc. (NASDAQ: GRAL) by 55.7% in the third quarter, according to its most recent 13F filing with the SEC. The fund owned 13,840 shares of the company's stock after selling 17,399 shares during the period. Cwm LLC's holdings in GRAIL were worth $818,000 at

In 2025, small-cap stocks underperformed. The Russell 2000 Index tracks the performance of 2,000 U.S. small-cap stocks, delivering a total return of around 13% in 2025.

Carnegie Investment Counsel boosted its stake in GRAIL, Inc. (NASDAQ: GRAL) by 48.1% in the third quarter, according to the company in its most recent disclosure with the SEC. The firm owned 245,315 shares of the company's stock after purchasing an additional 79,630 shares during the quarter. Carnegie Investment Counsel owned about 0.68%

Trump Media & Technology Group CEO Devin Nunes details a $6B merger with TAE Technologies to develop nuclear fusion reactors and prevent an energy crisis as high-powered data centers expand.

MENLO PARK, Calif. , Dec. 15, 2025 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced that company management will present at the 44th Annual J.P.

Caxton Associates LLP bought a new stake in GRAIL, Inc. (NASDAQ: GRAL) during the second quarter, according to its most recent filing with the Securities and Exchange Commission. The firm bought 64,560 shares of the company's stock, valued at approximately $3,320,000. Caxton Associates LLP owned about 0.18% of GRAIL as of its most

Early cancer detection is highly beneficial to sufferers, and Grail's Galleri test offers a solution. The company is the leader in the race for FDA approval, but it could benefit from being part of a larger company.

MENLO PARK, Calif. , Dec. 1, 2025 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced that it has granted equity awards in the form of restricted stock units ("RSUs") underlying an aggregate of 21,570 shares of GRAIL's common stock to 21 recently hired non-executive employees as an inducement material to their acceptance of employment with GRAIL.

Weary of being captive to geopolitics, car companies are looking for ways to replace powerful rare-earth magnets in electric motors.

Deutsche Bank appears to have set a high mark when it comes to forecasts for the S&P 500 in 2026, with a target of 8,000.

Retail investors are understandably on edge after several sessions of market volatility. But bestselling author and Oxford Club strategist Alexander Green, in his new book The American Dream, says we're still in one of the best times in history to build wealth—especially if you think long-term and stay grounded in time-tested principles.

MENLO PARK, Calif. , Nov. 18, 2025 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced that company management will present at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, Dec. 2 at 3:00 p.m.

The cancer diagnostics specialist received two price target increases from separate analysts. One more than doubled his on the company.

Grail (GRAL) reported Q3 revenues of $36.2m, up 26% YoY, but continues to post significant losses and faces commercial challenges. Galleri test's PATHFINDER 2 study showed promising early cancer detection, yet questions remain about detection rates, pricing, and broad adoption, in my view. GRAL's stock has surged 185% since my last Hold call, despite lack of FDA approval and ongoing uncertainty around reimbursement, market size, and future profitability.