Grail (NASDAQ: GRAL) stock came under even more pressure today, declining by more than 16% by 12:40 a.m. The move comes as the market continues to digest the unpalatable news that hit the market on Friday. The news wasn't good, but there is a pathway to recovery, however tenuous it might appear now. What happened to Grail stock recently I discussed the game-changing event on Friday. Simply put, the company's trial of its Galleri multi-cancer early detection (MCED) with England's National Health Service (N ...

Grail (GRAL) shares were cut in half on Feb. 20 after the biotech firm said its highly anticipated NHS-Galleri clinical trial failed to meet its primary endpoint. As retail and institutional investors bailed on GRAL today, its 14-day relative strength index (RSI) crashed to 24, indicating a technical rebound was likely in the near term. More News from Barchart Still, investors are recommended against buying the dip in Grail stock, even though it looks like a bargain at about $49. www.barchart.com Sho ...

Core Viewpoint - Grail's shares dropped nearly 50% after its three-year cancer screening trial failed to meet its primary goal, significantly impacting the company [1] Company Summary - Grail's three-year cancer screening trial aimed to demonstrate a reduction in late-stage cancer diagnoses and improve early detection within the National Health Service (NHS) [1] - The trial involved over 142,000 participants aged 50 to 77 years, but the main goal of achieving a statistically significant reduction was not met, although a favorable trend was noted over time [1] - Grail had previously filed for U.S. regulatory approval of its Galleri test based on data from a smaller U.S. trial and the first-year data from the larger trial [1] Industry Summary - The Galleri multi-cancer early detection test is recommended for adults aged 50 and older with an elevated risk for cancer [1] - The approval of Galleri by the FDA does not appear to be at material risk, but the consideration of NHS data by the Centers for Medicare and Medicaid Services (CMS) for coverage policy remains uncertain [1] - Recent legislation allows for insurance coverage of multi-cancer early detection tests under Medicare plans for older adults starting in 2028, depending on age [1]

GRAIL (NasdaqGS:GRAL) Q4 2025 Earnings call February 19, 2026 05:00 PM ET Speaker5Good day, ladies and gentlemen, and welcome to the GRAIL Fourth Quarter 2025 earnings call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. Please be advised that this conference call is being recorded. GRAIL Investor Relations, please begin.Speaker1Thank you, operator, and thank you all for joining us today. On the call are Bob Ragusa, our ...

Core Insights - GRAIL, Inc. reported significant commercial growth in 2025, with total revenue increasing by 17% year-over-year to $147.2 million and U.S. Galleri revenue growing by 26% to $136.8 million [1][4] - The company completed its Premarket Approval (PMA) submission to the FDA for the Galleri test and shared positive topline results from the NHS-Galleri trial, indicating a substantial reduction in Stage IV cancer diagnoses [1][2] - GRAIL's financial position remains strong, with cash and cash equivalents totaling $904.4 million as of December 31, 2025, providing financial flexibility for future growth [1][4] Financial Performance - For Q4 2025, total revenue was $43.6 million, a 14% increase year-over-year, while U.S. Galleri revenue reached $41.3 million, up 31% [1][4] - The net loss for Q4 2025 was $99.2 million, which includes $34.6 million in amortization related to the Illumina acquisition [1][4] - For the full year 2025, the net loss was $408.4 million, an improvement of $1.6 billion or 80% compared to the previous year [1][4] Business Highlights - GRAIL expanded access to the Galleri test through partnerships with digital health platforms, including the launch of the Hims & Hers Multi-Cancer Test [1][2] - The company completed the analysis of the full 35,000 participant PATHFINDER 2 study, demonstrating consistent performance with earlier results [1][2] - The NHS-Galleri trial results showed that adding Galleri to standard care screening significantly increased the detection rates of early-stage cancers [1][2] Cash Position - As of December 31, 2025, GRAIL had cash, cash equivalents, and short-term marketable securities totaling $904.4 million, ensuring operational sustainability into 2030 [1][4] Future Outlook - GRAIL anticipates continued commercial growth in 2026, with plans for new partnerships in digital health and further integration into health systems [1][2] - Detailed results from the PATHFINDER 2 and NHS-Galleri trials are expected to be presented in mid-2026 [1][2]

Core Insights - The NHS-Galleri trial demonstrated a significant reduction in Stage IV cancer diagnoses and an increase in the detection of Stage I and II cancers, although the primary endpoint of statistically significant reduction in Stage III-IV cancers was not met [1][2] Group 1: Trial Results - The Galleri test led to a substantial reduction in cancers detected through emergency presentations, which are linked to higher mortality and healthcare costs [1] - There was a notable increase in the absolute number of Stage I-II cancers among 12 pre-specified deadly cancer types in the intervention group [1] - The overall cancer detection rate improved four-fold when Galleri was added to standard care screening compared to standard care alone for breast, colorectal, cervical, and high-risk lung cancers [1] - A clinically meaningful reduction in Stage IV diagnoses was observed, with over a 20% decrease in the second and third rounds of sequential screening for the specified group of cancers [1][2] Group 2: Trial Design and Objectives - The NHS-Galleri trial is the largest randomized controlled trial assessing a multi-cancer early detection test, involving over 142,000 participants aged 50 to 77 [2] - The primary objective was to show a reduction in late-stage (III-IV) cancers in those receiving the Galleri test compared to those who did not [2] - Secondary objectives included evaluating the performance of the Galleri test, safety, and healthcare resource utilization [2] Group 3: Company and Product Information - GRAIL, Inc. focuses on early cancer detection using next-generation sequencing and machine learning to identify multiple cancer types at earlier stages [2] - The Galleri test can detect over 50 types of cancer through a simple blood draw, significantly increasing the number of cancers detected when used alongside standard screenings [2] - The test is recommended for adults aged 50 or older with an elevated risk for cancer and has the lowest false positive rate among multi-cancer early detection tests [2]

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]

Core Insights - Grail's stock has seen a significant increase of over 13% due to growing optimism about its future prospects, particularly for 2026, following a positive presentation at the JPMorgan Healthcare Conference [1] Financial Performance - Grail's Galleri MCED test has been commercially available for four years, generating sales with projected total revenue for 2025 estimated between $147 million and $148 million, primarily driven by Galleri, which is expected to contribute $136 million to $137 million [2] - For 2026, management anticipates Galleri revenue growth of 22% to 32%, while cash burn is expected to decrease to $274 million in 2025 from $579 million in 2024, supported by a cash position of $904 million [3] Regulatory Developments - A key driver of excitement for Grail is its planned premarket approval (PMA) submission to the FDA in the first quarter of 2026, which could enhance medical and insurance coverage for the Galleri test, as well as improve marketing and physician adoption [4] - The PMA submission will be supported by data from the Pathfinder 2 trial in the U.S. and a large-scale trial in the U.K. involving 140,000 participants, which may facilitate U.K. adoption of the test [5]

As filed with the U.S. Securities and Exchange Commission on December 12, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 20/20 BIOLABS, INC. (Exact name of registrant as specified in its charter) Delaware 8734 57-2272107 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 15810 Gaither ...

Core Insights - Grail is a leader in the multi-cancer early detection (MCED) market, with its stock rising 20.1% in November following positive third-quarter results and an analyst day [1] Company Overview - Grail's Galleri test screens for over 50 types of cancer and is the first MCED available commercially, although it has not yet received FDA approval, which management aims to achieve by the first half of 2026 [2] - The company faces competition from larger firms like Exact Sciences, which has its own MCED product, CancerGuard [2] Strategic Goals - Grail aims to grow commercial sales of Galleri while reducing cash burn, with a reported 39% year-over-year growth in Galleri tests in Q3, generating $32.6 million in revenue [3] - Cash burn has decreased to $59 million from $71.8 million in the previous quarter and $105.2 million a year ago [3] Financial Position - Following a successful private placement, Grail has a cash position of $850 million with no long-term debt, providing significant resources ahead of potential FDA approval for Galleri [4] Market Dynamics - The recent acquisition of Exact Sciences by Abbott Labs for a substantial premium underscores the attractiveness of the MCED market, raising speculation about potential acquisitions, including Grail [5] - Grail's Galleri test offers significant benefits for early cancer detection, positioning the company as a strong candidate for acquisition by larger firms [6] Acquisition Potential - Larger companies are likely to acquire firms like Grail and Exact Sciences due to their resources and market presence, with Grail being viewed as a more attractive acquisition target compared to Exact Sciences, which already has an FDA-approved product [7]