Key Takeaways GRAIL submitted the final PMA module to the FDA for its Galleri multi-cancer early detection blood test.The Galleri test holds FDA Breakthrough status, backed by U.S. PATHFINDER 2 results and the NHS-Galleri trial.The PMA includes data from 25,490 participants in PATHFINDER 2 and the first round of the NHS-Galleri trial.GRAIL, Inc. (GRAL) announced the submission of the final module of its premarket approval application to the FDA for the Galleri multi-cancer early detection (MCED) test. The F ...

Core Insights - GRAIL, Inc. has submitted the final module of the Premarket Approval (PMA) application for its Galleri multi-cancer early detection (MCED) test to the FDA, marking a significant milestone in early cancer detection [1][2] - The Galleri test has been designated as a Breakthrough Device by the FDA since 2018, highlighting its potential to improve cancer screening outcomes [1][2] Company Overview - GRAIL is focused on early cancer detection using next-generation sequencing and advanced machine learning technologies, aiming to alleviate the global burden of cancer [5] - The company is headquartered in Menlo Park, California, with additional locations in Washington, D.C., North Carolina, and the United Kingdom [5] Clinical Studies - The PMA submission is based on data from the PATHFINDER 2 study, which involved 25,490 participants, and the NHS-Galleri trial, the largest randomized controlled trial of any MCED test [2][3] - The NHS-Galleri trial recruited over 140,000 asymptomatic participants aged 50 to 77, aiming to demonstrate a reduction in late-stage cancers among those who received the Galleri test [3] - The PATHFINDER 2 study evaluates the safety and performance of the Galleri test in approximately 35,000 individuals eligible for cancer screening, focusing on diagnostic evaluations and performance metrics [4] Test Performance and Objectives - The primary objective of the NHS-Galleri trial is to show a reduction in late-stage (III-IV) cancers, particularly in a pre-specified group of 12 cancer types that account for about two-thirds of cancer deaths in England and the U.S. [3] - Secondary objectives include assessing the performance of the Galleri test in terms of positive predictive value, false positive rate, cancer detection rate, and healthcare resource utilization [3][4]

Key Points 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. 10 stocks we like better than Grail › Shares in multi-cancer early detection (MCED) company, Grail (NASDAQ: GRAL), rose by more than 13% to 3 p.m. today. The move comes as optimism mounts over the company's prospects in 2026. An upbeat presentation at the recent JPM ...

Core Insights - The article emphasizes the importance of understanding market dynamics and the potential impact of macroeconomic factors on investment strategies [2] Group 1: Market Analysis - The current market environment is characterized by volatility, influenced by geopolitical tensions and economic indicators [2] - Analysts suggest that investors should remain cautious and consider diversifying their portfolios to mitigate risks associated with market fluctuations [2] Group 2: Company Performance - Recent earnings reports indicate a mixed performance across various sectors, with some companies exceeding expectations while others fall short [2] - Specific companies have shown resilience in adapting to changing market conditions, highlighting the importance of strategic management [2]

Company Overview - GRAIL has made significant progress since launching Galleri in 2021, which allows individuals and their physicians to detect cancers before symptoms appear, often at earlier stages [3] - Galleri is recognized as the first multi-cancer early detection test, establishing a new paradigm in cancer screening [3] Product Performance - The performance of Galleri has been validated through various studies, including a recent analysis involving the first 25,000 participants [3]

Summary of GRAIL's Conference Call Company Overview - **Company**: GRAIL - **Product**: Galleri, a multi-cancer early detection test launched in 2021 - **Industry**: Cancer screening and diagnostics Key Points and Arguments Business Progress and Financials - GRAIL has completed over 800,000 Galleri tests and sold more than 185,000 tests in 2025, indicating strong commercial momentum [4][7] - Revenue for 2025 is projected to be between $147 million and $148 million, representing a growth of approximately 17%-18% over 2024 [9] - The company ended 2025 with $904 million in cash, providing a strong capital position for future growth [5] - Cash burn for 2025 was approximately $274 million, significantly reduced from $579 million in 2024 due to organizational restructuring [10] Market Expansion and Partnerships - GRAIL plans to expand Galleri in the U.S. and international markets, with partnerships established in Israel, Canada, and South Korea [9][24] - The prescriber base grew by approximately 30% in 2025, reaching over 17,000 prescribers, indicating increased adoption among healthcare providers [7] - The company is working with operational partners like Quest and Athena to streamline test ordering and execution [8] Clinical Validation and Performance - Galleri is the only multi-cancer early detection test with published validation data in the intended use population, demonstrating a positive predictive value of 62% and a false positive rate of 0.4% [14][20] - The PATHFINDER 2 study showed a seven-fold increase in cancer detection rates when Galleri was added to standard screenings, with over half of detected cancers found at early stages [19][20] - The test is designed to detect over 100 types of cancer, significantly more than the 14% detection rate of current single cancer screenings [12][15] Future Outlook and Regulatory Plans - GRAIL expects to file for PMA (Pre-Market Approval) in Q1 2026 and present full data sets from major studies in mid-2026 [6][21] - The company anticipates total Galleri revenue growth of 22%-32% in 2026, with cash burn expected to be less than $300 million [10] Strategic Vision - GRAIL aims to transform cancer screening by moving away from individual cancer tests to a comprehensive approach that detects multiple cancers simultaneously [12][13] - The company emphasizes the importance of clinical utility and aims to demonstrate the reduction of late-stage cancer incidence through its testing [22][24] Additional Important Insights - GRAIL's automated lab infrastructure allows for a testing capacity of one million samples per year, with plans for further expansion [18] - The company is focused on achieving FDA approval, which is expected to enhance market adoption and reimbursement opportunities [24] - GRAIL's strategy includes leveraging consumer empowerment trends in healthcare, which may increase self-pay market growth for preventive services like Galleri [24] This summary encapsulates the key points discussed during the conference call, highlighting GRAIL's business progress, market strategies, clinical validation, and future outlook in the cancer screening industry.

Corporate Update - GRAIL, Inc. plans to present a corporate update and preliminary financial information for the quarter and year ended December 31, 2025 at the 2026 J.P. Morgan Healthcare Conference[4] - The presentation will include results of operations and financial condition, which are expected to be detailed in Exhibit 99.1[6] Company Classification - The company is classified as an emerging growth company under the Securities Act of 1933[3]

44th Annual J.P. Morgan Healthcare Conference January 12, 2026 Bob Ragusa, Chief Executive Officer Josh Ofman, President 1 This presentation contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "should," "would," or "will," the negative of these terms, and other comparable terminology. These forward-looking stat ...

Core Insights - In 2025, small-cap stocks underperformed compared to large-cap stocks, with the Russell 2000 Index delivering a total return of approximately 13%, while the S&P 500 Index achieved around 18% [2] - Despite the overall underperformance, three small-cap stocks achieved exceptional returns of 300% or more, transitioning into mid-cap status [3] Company Performance - GRAIL, a healthcare company focused on early cancer detection, saw its stock price increase by approximately 380% in 2025, raising its market capitalization from below $1 billion to around $3.3 billion [3] - GRAIL's main product, the Galleri Multi-Cancer Early Detection test, is designed to detect over 50 types of cancer, significantly improving early detection rates [4] - The company plans to apply for Premarket Approval (PMA) from the U.S. FDA in Q1 2026, which could lead to commercial insurers covering the test, unlocking a new sales channel [5] Market Outlook - Analysts have a consensus price target of $97.50 for GRAIL, indicating an optimistic outlook with an implied upside of around 14% [6]

Group 1 - Grail Inc. (NASDAQ:GRAL) experienced a significant increase of 379.5 percent in 2025, driven by positive analyst ratings and confidence in its early cancer detection test kit, Galleri [1] - Galleri is a single blood test designed to screen over 50 types of cancer, with a reported positive predictive value of 61.6 percent from its Pathfinder 2 clinical study [1] - Samsung group has backed Grail Inc. for the exclusive distribution of Galleri in South Korea and other key Asian markets, acquiring a $110 million stake at a price of $70.05 per share [2] Group 2 - Analysts have shown optimism towards Grail Inc., with Canaccord issuing a "buy" recommendation and raising its price target to $105, while Morgan Stanley increased its target to $110, maintaining an "equal weight" rating [2] - Grail Inc. plans to seek FDA pre-market approval for Galleri within the first quarter of 2026 [2]