GRAIL（NL0）株式概要商業段階のヘルスケア企業であるGRAIL, Inc.は、米国内外で複数のがん早期発見検査とサービスを提供している。 詳細NL0 ファンダメンタル分析スノーフレーク・スコア評価0/6将来の成長2/6過去の実績0/6財務の健全性6/6配当金0/6報酬収益は年間23.06%増加すると予測されています 過去5年間の収益は年間6.3%増加しました。 リスク分析株式の流動性は非常に低い 今後3年間の収益は年平均5.9%減少すると予測されている。 現在は利益が出ておらず、今後3年間で利益が出る見込みはない 過去3か月間に大規模なインサイダー売却が発生 +1 さらなるリスクすべてのリスクチェックを見るNL0 Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair Value€Current Price€38.3463.6% 割高 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-4b441m2016201920222025202620282031Revenue US$440.7mEarnings US$80.1mAdvancedSet Fair ValueView all narrativesGRAIL, Inc. 競合他社Biotest GmbH KGaASymbol: HMSE:BIO0Market cap: €1.5bBiotestSymbol: XTRA:BIO3Market cap: €1.4bFormyconSymbol: XTRA:FYBMarket cap: €354.3mDextech MedicalSymbol: DB:LQ0Market cap: €184.9m価格と性能株価の高値、安値、推移の概要GRAIL過去の株価現在の株価US$38.3452週高値US$81.8052週安値US$27.90ベータ01ヶ月の変化0%3ヶ月変化n/a1年変化n/a3年間の変化n/a5年間の変化n/aIPOからの変化142.47%最新ニュースお知らせ • Apr 30GRAIL, Inc., Annual General Meeting, Jun 18, 2026GRAIL, Inc., Annual General Meeting, Jun 18, 2026.お知らせ • Apr 23GRAIL, Inc. to Report Q1, 2026 Results on May 05, 2026GRAIL, Inc. announced that they will report Q1, 2026 results After-Market on May 05, 2026お知らせ • Apr 08GRAIL, Inc. Announces Integration of Galleri Test into Epic Electronic Health Record PlatformGRAIL, Inc. announced a collaboration with Epic to bring the Galleri multi-cancer early detection test into one of the nation's most widely used electronic health record platforms, supporting broader adoption across health systems in the United States. Epic is a leading EHR platform used by many of the largest and most advanced health systems. Integration through Epic Aura will allow interested health systems and their healthcare providers to order the Galleri test directly at the point of care, receive results, and manage patient follow-up seamlessly within their existing native EHR and within their existing clinical workflows. Through this integration, clinicians using Epic can access the Galleri test within their native EHR environment, helping to eliminate administrative burden, reduce manual processes, and improve the overall provider and patient experience. Implementation planning began in the first quarter of 2026, including initial integrations and early adopter programs. GRAIL will work closely with Epic and AWS, the preferred cloud provider for GRAIL, along with any interested health systems, community healthcare providers, and retail health clinics to support workflow alignment, training and deployment success. Broad availability is expected by the end of 2026. The Galleri multi-cancer early detection test is a proactive tool to screen for cancer. With a simple blood draw, Galleri can detect more than 50 types of cancer before symptoms appear — when they can be easier to treat and are potentially curable. Galleri is the only available MCED test with demonstrated performance in patients screened for cancer. The Galleri test increases the number of cancers detected seven-fold when added to recommended screening for breast, cervical, colorectal and lung cancers, and has the lowest false positive rate of any MCED test on the market. The Galleri test doubles the number of cancers detected when added to standard of care cancer screening, and has the lowest false positive rate of any MCED test. When a cancer signal is found, Galleri provides a cancer signal of origin with high accuracy to help guide an efficient diagnostic work-up. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen test, or cervical cancer screening. The Galleri test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older.お知らせ • Mar 13+ 1 more updateGRAIL, Inc. Announces Chief Executive Officer Changes, Effective June 1, 2026GRAIL, Inc. announced that Bob Ragusa will retire as Chief Executive Officer, effective June 1, 2026. Ragusa will remain on GRAIL's Board until June 1, 2026, and plans to serve in a senior advisory role through March of 2027. GRAIL's Board of Directors has appointed the Company's President, Josh Ofman, MD, MSHS, to serve as GRAIL's Chief Executive Officer upon Ragusa's retirement. Ofman joined GRAIL in 2019 and brings extensive experience in clinical medicine, biopharmaceutical leadership, health policy and precision medicine. He has served on numerous industry Boards, including BIO and the Precision Medicine Coalition. Before joining GRAIL, Ofman spent more than 15 years at Amgen, most recently as Senior Vice President, Global Value, Access and Policy. Earlier in his career, he was a faculty member in the Department of Medicine and Health Services Research at the UCLA School of Medicine and the Division of Digestive Diseases at Cedars-Sinai Medical Center, and served as Senior Vice President of Zynx Health Inc., a subsidiary of Cerner Corp.Reported Earnings • Feb 23Full year 2025 earnings released: US$11.11 loss per share (vs US$63.54 loss in FY 2024)Full year 2025 results: US$11.11 loss per share (improved from US$63.54 loss in FY 2024). Revenue: US$147.2m (up 17% from FY 2024). Net loss: US$408.4m (loss narrowed 80% from FY 2024). Revenue is forecast to grow 22% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Europe.お知らせ • Feb 20GRAIL, Inc. Announces NHS Galleri Trial Demonstrates A Substantial Reduction in Stage IV Cancer Diagnoses, Increased Stage I and II Detection of Deadly Cancers, and Four-Fold Higher Cancer Detection RateGRAIL, Inc. announced topline results from the landmark, randomized, controlled NHS-Galleri trial, which evaluated annual multi-cancer screening with the Galleri test in England's National Health Service (NHS) over three years in 142,000 demographically representative participants aged 50 to 77. The clinical performance of Galleri has been rigorously established in several studies, and the NHS-Galleri trial was designed to demonstrate population-level impact through the reduction of late stage cancer diagnoses and increased cancer detection rate within the NHS to inform a decision about a national screening program in England. For the US market, the Galleri premarket approval application pending review by the FDA also includes metrics from the NHS-Galleri trial that are focused on test performance, clinical validation, and the clinical benefit of detection at Stages I through III, including reduction in Stage IV cancer diagnoses. Key trial results include: The primary endpoint of statistically significant Stage III-IV reduction was not observed. However, there was a favorable trend toward fewer Stage III-IV cancers in a pre-specified group of 12 deadly cancers in the intervention arm after the prevalent screening round. Adding Galleri to standard of care screening resulted in a substantial and clinically meaningful reduction in Stage IV diagnoses compared with standard of care alone across the pre-specified group of 12 deadly cancers. Stage IV diagnoses in these cancers decreased with each year of sequential screening, with a greater than 20% reduction in the second and third rounds. Similar reductions were observed across all cancers. Annual screening with the Galleri test plus standard of care screening resulted in a four-fold improvement in the overall cancer detection rate compared to standard of care screening alone in England for breast, colorectal, cervical and high risk lung cancer. Substantial increase in the absolute number of Stage I-II cancers in the 12 pre-specified deadly cancer types that are typically found in late stages were observed in the intervention arm. Screening with the Galleri test resulted in a substantial reduction in the number of cancers detected clinically through emergency presentation, which are associated with significantly higher mortality and healthcare costs. The Galleri test's performance – positive predictive value (PPV), specificity and Cancer Signal of Origin (CSO) accuracy – was consistent with the range previously reported from GRAIL's North American studies. Importantly, no serious safety concerns were reported in participants who received the Galleri test in the NHS-Galleri trial. Additional analyses are underway to better understand these rich data, and detailed results will be submitted for presentation at the ASCO 2026 Annual Meeting. Of note, there was a higher than anticipated incidence of Stage III cancers in the NHS-Galleri trial. In both the US and the NHS data, the time to diagnostic resolution appears to improve over time as physicians gain experience with the Galleri test and diagnostic workup. The number and distribution of cancer stages across screening rounds suggests the potential for a stronger effect with longer follow up as data matures, and GRAIL plans to extend the trial's follow up period by 6-12 months.最新情報をもっと見るRecent updatesお知らせ • Apr 30GRAIL, Inc., Annual General Meeting, Jun 18, 2026GRAIL, Inc., Annual General Meeting, Jun 18, 2026.お知らせ • Apr 23GRAIL, Inc. to Report Q1, 2026 Results on May 05, 2026GRAIL, Inc. announced that they will report Q1, 2026 results After-Market on May 05, 2026お知らせ • Apr 08GRAIL, Inc. Announces Integration of Galleri Test into Epic Electronic Health Record PlatformGRAIL, Inc. announced a collaboration with Epic to bring the Galleri multi-cancer early detection test into one of the nation's most widely used electronic health record platforms, supporting broader adoption across health systems in the United States. Epic is a leading EHR platform used by many of the largest and most advanced health systems. Integration through Epic Aura will allow interested health systems and their healthcare providers to order the Galleri test directly at the point of care, receive results, and manage patient follow-up seamlessly within their existing native EHR and within their existing clinical workflows. Through this integration, clinicians using Epic can access the Galleri test within their native EHR environment, helping to eliminate administrative burden, reduce manual processes, and improve the overall provider and patient experience. Implementation planning began in the first quarter of 2026, including initial integrations and early adopter programs. GRAIL will work closely with Epic and AWS, the preferred cloud provider for GRAIL, along with any interested health systems, community healthcare providers, and retail health clinics to support workflow alignment, training and deployment success. Broad availability is expected by the end of 2026. The Galleri multi-cancer early detection test is a proactive tool to screen for cancer. With a simple blood draw, Galleri can detect more than 50 types of cancer before symptoms appear — when they can be easier to treat and are potentially curable. Galleri is the only available MCED test with demonstrated performance in patients screened for cancer. The Galleri test increases the number of cancers detected seven-fold when added to recommended screening for breast, cervical, colorectal and lung cancers, and has the lowest false positive rate of any MCED test on the market. The Galleri test doubles the number of cancers detected when added to standard of care cancer screening, and has the lowest false positive rate of any MCED test. When a cancer signal is found, Galleri provides a cancer signal of origin with high accuracy to help guide an efficient diagnostic work-up. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen test, or cervical cancer screening. The Galleri test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older.お知らせ • Mar 13+ 1 more updateGRAIL, Inc. Announces Chief Executive Officer Changes, Effective June 1, 2026GRAIL, Inc. announced that Bob Ragusa will retire as Chief Executive Officer, effective June 1, 2026. Ragusa will remain on GRAIL's Board until June 1, 2026, and plans to serve in a senior advisory role through March of 2027. GRAIL's Board of Directors has appointed the Company's President, Josh Ofman, MD, MSHS, to serve as GRAIL's Chief Executive Officer upon Ragusa's retirement. Ofman joined GRAIL in 2019 and brings extensive experience in clinical medicine, biopharmaceutical leadership, health policy and precision medicine. He has served on numerous industry Boards, including BIO and the Precision Medicine Coalition. Before joining GRAIL, Ofman spent more than 15 years at Amgen, most recently as Senior Vice President, Global Value, Access and Policy. Earlier in his career, he was a faculty member in the Department of Medicine and Health Services Research at the UCLA School of Medicine and the Division of Digestive Diseases at Cedars-Sinai Medical Center, and served as Senior Vice President of Zynx Health Inc., a subsidiary of Cerner Corp.Reported Earnings • Feb 23Full year 2025 earnings released: US$11.11 loss per share (vs US$63.54 loss in FY 2024)Full year 2025 results: US$11.11 loss per share (improved from US$63.54 loss in FY 2024). Revenue: US$147.2m (up 17% from FY 2024). Net loss: US$408.4m (loss narrowed 80% from FY 2024). Revenue is forecast to grow 22% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Europe.お知らせ • Feb 20GRAIL, Inc. Announces NHS Galleri Trial Demonstrates A Substantial Reduction in Stage IV Cancer Diagnoses, Increased Stage I and II Detection of Deadly Cancers, and Four-Fold Higher Cancer Detection RateGRAIL, Inc. announced topline results from the landmark, randomized, controlled NHS-Galleri trial, which evaluated annual multi-cancer screening with the Galleri test in England's National Health Service (NHS) over three years in 142,000 demographically representative participants aged 50 to 77. The clinical performance of Galleri has been rigorously established in several studies, and the NHS-Galleri trial was designed to demonstrate population-level impact through the reduction of late stage cancer diagnoses and increased cancer detection rate within the NHS to inform a decision about a national screening program in England. For the US market, the Galleri premarket approval application pending review by the FDA also includes metrics from the NHS-Galleri trial that are focused on test performance, clinical validation, and the clinical benefit of detection at Stages I through III, including reduction in Stage IV cancer diagnoses. Key trial results include: The primary endpoint of statistically significant Stage III-IV reduction was not observed. However, there was a favorable trend toward fewer Stage III-IV cancers in a pre-specified group of 12 deadly cancers in the intervention arm after the prevalent screening round. Adding Galleri to standard of care screening resulted in a substantial and clinically meaningful reduction in Stage IV diagnoses compared with standard of care alone across the pre-specified group of 12 deadly cancers. Stage IV diagnoses in these cancers decreased with each year of sequential screening, with a greater than 20% reduction in the second and third rounds. Similar reductions were observed across all cancers. Annual screening with the Galleri test plus standard of care screening resulted in a four-fold improvement in the overall cancer detection rate compared to standard of care screening alone in England for breast, colorectal, cervical and high risk lung cancer. Substantial increase in the absolute number of Stage I-II cancers in the 12 pre-specified deadly cancer types that are typically found in late stages were observed in the intervention arm. Screening with the Galleri test resulted in a substantial reduction in the number of cancers detected clinically through emergency presentation, which are associated with significantly higher mortality and healthcare costs. The Galleri test's performance – positive predictive value (PPV), specificity and Cancer Signal of Origin (CSO) accuracy – was consistent with the range previously reported from GRAIL's North American studies. Importantly, no serious safety concerns were reported in participants who received the Galleri test in the NHS-Galleri trial. Additional analyses are underway to better understand these rich data, and detailed results will be submitted for presentation at the ASCO 2026 Annual Meeting. Of note, there was a higher than anticipated incidence of Stage III cancers in the NHS-Galleri trial. In both the US and the NHS data, the time to diagnostic resolution appears to improve over time as physicians gain experience with the Galleri test and diagnostic workup. The number and distribution of cancer stages across screening rounds suggests the potential for a stronger effect with longer follow up as data matures, and GRAIL plans to extend the trial's follow up period by 6-12 months.お知らせ • Feb 16GRAIL, Inc. to Report Q4, 2025 Results on Feb 19, 2026GRAIL, Inc. announced that they will report Q4, 2025 results After-Market on Feb 19, 2026お知らせ • Jan 30GRAIL, Inc. Submits FDA Premarket Approval Application for the Galleri®? Multi-Cancer Early Detection TestGRAIL, Inc. 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. The FDA designated the test as a Breakthrough Device in 2018. The PMA submission is focused on the test performance and safety results from 25,490 consented participants in the US-based PATHFINDER 2 study with one year of follow up and from the prevalent screening round (first year) of the NHS-Galleri trial, the largest, and only, randomized, controlled trial of any MCED test in an intended use population. The submission is also supported by a bridging analysis to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated PMA version that has been submitted to the FDA for premarket approval. About the NHS-Galleri trial (NCT05611632) The NHS-Galleri trial is the first and only prospective, randomized, controlled trial to assess the clinical utility and performance of a multi-cancer early detection test for population screening when added to standard care. PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of the Galleri in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States. The primary objectives of the study are 1) to evaluate the safety and performance of theGalleri MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result, and 2) to evaluate the performance of the Galleri MCED test across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy. Participants who receive a cancer signal detected result undergo additional diagnostic testing based on the predicted CSO to determine if a cancer is present.お知らせ • Jan 15GRAIL, Inc. Provides Earnings Guidance for the Full Year 2025GRAIL, Inc. provided earnings guidance for the full year 2025. Revenue is expected to be between $147 million and $148 million, approximately 17% to 18% growth over 2024.お知らせ • Nov 14GRAIL, Inc. has filed a Follow-on Equity Offering in the amount of $300 million.GRAIL, Inc. has filed a Follow-on Equity Offering in the amount of $300 million. Security Name: Common Stock Security Type: Common Stock Transaction Features: At the Market OfferingReported Earnings • Nov 14Third quarter 2025 earnings released: US$2.46 loss per share (vs US$3.94 loss in 3Q 2024)Third quarter 2025 results: US$2.46 loss per share (improved from US$3.94 loss in 3Q 2024). Revenue: US$36.2m (up 26% from 3Q 2024). Net loss: US$89.0m (loss narrowed 29% from 3Q 2024). Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Europe.お知らせ • Nov 08GRAIL, Inc. announced that it has received $324.999987 million in funding from Samsung Electronics Co., Ltd., Samsung Electronics Singapore Pte. Ltd., Samsung C&T CorporationOn November 7, 2025, GRAIL, Inc closed the transaction. The transaction included participation from 17 investors.お知らせ • Oct 30GRAIL, Inc. to Report Q3, 2025 Results on Nov 12, 2025GRAIL, Inc. announced that they will report Q3, 2025 results After-Market on Nov 12, 2025お知らせ • Oct 21Grail, Inc. and University of Oxford to Present Long-Term Data from the Symplify Study Evaluating the Galleri®? Multi-Cancer Early Detection Test in Symptomatic Individuals At the Early Detection of Cancer ConferenceGRAIL, Inc. and the University of Oxford announced that positive long-term results from an extended registry follow-up of the SYMPLIFY study will be presented on Oct. 21 at the Early Detection of Cancer Conference (EDCC) in Portland, Oregon. SYMPLIFY, a prospective observational study, is the first large-scale evaluation of a multi-cancer early detection (MCED) test in individuals who presented with symptoms to primary care and were referred for diagnostic follow-up for suspicion of cancer. In SYMPLIFY, the Galleri®? test was used to assess blood samples from more than 6,000 participants with symptoms of cancer who followed standard diagnostic pathways. However, as a non-interventional study, the results of the tests were unknown to physicians and did not inform the approach to diagnosis. No MCED results were returned to participants or their clinicians during the study. Previous SYMPLIFY results showed potential of MCED testing in people with symptoms suggestive of cancer Most people diagnosed with cancer visit primary care with symptoms before diagnosis1. The fact that, in all but one of the additional patients diagnosed with cancer, a Galleri CSO prediction correctly identified the cancer type, including in many cases where the symptoms were non-specific, further reinforces the value of the Galleri test's CSO capability.Recent Insider Transactions • Oct 19CEO & Director recently sold €429k worth of stockOn the 15th of October, Robert Ragusa sold around 7k shares on-market at roughly €59.21 per share. This transaction amounted to 3.3% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth €4.3m. Robert has been a net seller over the last 12 months, reducing personal holdings by €3.5m.お知らせ • Oct 18GRAIL, Inc. Announces Positive Performance and Safety Results from its Registrational Pathfind 2 StudyGRAIL, Inc. announced that positive performance and safety results from its registrational PATHFINDER 2 study are being presented at the European Society for Medical Oncology (ESMO) Congress 20251. The largest interventional study of an MCED test in the United States to date, the prospective PATHFINDER 2 study includes 35,878 enrolled participants across the United States and Canada in a broad, intended-use population of adults aged 50 and older with no clinical pinpoint of cancer. Results were presented from a pre-specified analysis of the first 25,578 participants with at least 12 months of follow-up as of Dec. 31, 2024. The likelihood of receiving a cancer diagnosis following a positive test result (positive predictive value) was 61.6%, substantially higher than in the previous PATHFINDER study of Galleri. Since PATHFINDER 2 is a prospective clinical trial where the cancer status of participants is unknown at the outset, episode sensitivity - the ability to detect cancer that could be confirmed within 12 months after the blood draw - is a performance measure of the study. Data from this study will be submitted to the U.S. Food and Drug Administration (FDA) as part of the Galleri premium approval (PMA) application, along with data from the prevalent screening round of the NHS-Galleri trial. In addition, GRAIL will submit to the FDA a bridging analysis to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated version that GRAIL plans to submit to the FDA for premarket approval. The primary objectives of the study are 1) to evaluate the safety and performance of the Galleri MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result, and 2) to evaluate the performance of the GalleriMCED test across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs, and symptoms. A test result of No Cancer Signal detected does not rule out cancer. A test result of Cancer Signal detected requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirmatory diagnostic evaluation by medically establish procedures (e.g., Imaging) to confirm cancer. The Galleri test was developed -- and its performance characteristics were determined -- by GRAIL. The Galleri test has not been cleared or approved by the Food and Drug Administration. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about GRAIL, Inc. (the "Company"), include the benefits and use of the Galleri test, the potential of the Galleri MCED tests, expectations regarding the final results of the PATHFINDER 2 Study, upcoming events and presentations, the timeline and results of a bridging analysis to the FDA, the applicability of the Galleri test, and the applicability of the Galler test, and the timeline for completion of the PMO and the timeline for completion of The PMO and the first phase of the study.お知らせ • Oct 17GRAIL, Inc. announced that it expects to receive $110.000075 million in funding from Samsung Electronics Co., Ltd., Samsung Electronics Singapore Pte. Ltd and Samsung C&T CorporationGRAIL, Inc. entered into a stock purchase agreement for issuance of 1,570,308 common shares at a price of $70.05 per share for gross proceeds of $110,000,075.4 on October 16, 2025. The transaction included participation from new investors Samsung Electronics Co., Ltd., Samsung Electronics Singapore Pte. Ltd. and Samsung C&T Corporation. The Private Placement is exempt from the registration requirements of the Securities Act, pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) and/or Rule 506 of Regulation D under the Securities Act and in reliance on similar exemptions under applicable state laws. The transaction closing is subject to regulatory approvals.Recent Insider Transactions • Oct 10President recently sold €4.3m worth of stockOn the 6th of October, Joshua Ofman sold around 81k shares on-market at roughly €53.37 per share. This transaction amounted to 33% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Joshua has been a net seller over the last 12 months, reducing personal holdings by €6.0m.Reported Earnings • Aug 13Second quarter 2025 earnings released: US$3.19 loss per share (vs US$51.06 loss in 2Q 2024)Second quarter 2025 results: US$3.19 loss per share (improved from US$51.06 loss in 2Q 2024). Revenue: US$35.5m (up 11% from 2Q 2024). Net loss: US$114.0m (loss narrowed 93% from 2Q 2024). Revenue is forecast to grow 19% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Europe.お知らせ • Aug 13GRAIL, Inc. Reports Impairment Charges for the Second Quarter Ended June 30, 2025GRAIL, Inc. reported impairment charges for the second quarter ended June 30, 2025. For the quarter, the company reported goodwill and intangible impairment of $28,000,000 against $1,420,936,000 a year ago.お知らせ • Jul 30GRAIL, Inc. to Report Q2, 2025 Results on Aug 12, 2025GRAIL, Inc. announced that they will report Q2, 2025 results After-Market on Aug 12, 2025お知らせ • Jun 30+ 4 more updatesGRAIL, Inc.(NasdaqGS:GRAL) dropped from Russell Midcap Value IndexGRAIL, Inc.(NasdaqGS:GRAL) dropped from Russell Midcap Value Indexお知らせ • Jun 18GRAIL, Inc. Announces Positive Top-Line Results from The Galleri PATHFINDER 2 Registrational StudyGRAIL, Inc. announced positive top-line performance and safety results from the pre-specified analysis of the first 25,578 participants in GRAIL's registrational PATHFINDER 2 study. PATHFINDER 2 was initiated in 2021 to evaluate the safety and performance of the Galleri®? multi-cancer early detection (MCED) test when added to standard of care single cancer screening in 35,878 adults over 50 years of age with no clinical suspicion of cancer. PATHFINDER 2 study results will be submitted to the U.S. Food and Drug Administration (FDA) as part of the Galleri premarket approval application (PMA), along with data from the prevalent screening round of the NHS-Galleri trial. In addition, GRAIL will submit to the FDA bridging analyses to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated version that GRAIL plans to submit to the FDA for premarket approval. The PMA for Galleri is currently in process with a modular submission under a Breakthrough Device Designation from the FDA. GRAIL expects to complete the PMA modular submission in the first half of 2026. Detailed results from the PATHFINDER 2 Study (NCT05155605). PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States. The primary objectives of the study are 1) to evaluate the safety and effectiveness of the Galleri MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result, and 2) to evaluate the performance of the Galleri MCED tests across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy. Participants who receive a cancer signal detected result undergo additional diagnostic testing based on the predicted CSO to determine if a cancer is present. Use of the test is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs, and symptoms. A test result of No Cancer Signal detected does not rule out cancer. A test result of Cancer Signal detected requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirmatory diagnostic evaluation by medically establish procedures (e.g., Imaging) to confirmatory diagnostic evaluation of cancer, including due to the cancer being located in a different part of the body. false negative (a cancer signal not detected when cancer is present) test results do occur. Rx only. The GRAIL clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed -- and its performance characteristics were determined -- by GRAIL. The Galleri test has not been cleared or approved by the Food and Drug Administration. The Galleri test was regulated under CLIA to perform high-complexity testing.お知らせ • Apr 30GRAIL, Inc. to Report Q1, 2025 Results on May 13, 2025GRAIL, Inc. announced that they will report Q1, 2025 results After-Market on May 13, 2025お知らせ • Apr 17GRAIL, Inc., Annual General Meeting, May 29, 2025GRAIL, Inc., Annual General Meeting, May 29, 2025.Reported Earnings • Feb 22Full year 2024 earnings releasedFull year 2024 results: US$63.54 loss per share. Revenue: US$125.6m (up 35% from FY 2023). Net loss: US$2.03b (loss widened 38% from FY 2023). Revenue is forecast to grow 14% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in Europe.お知らせ • Feb 13GRAIL, Inc. to Report Q4, 2024 Results on Feb 20, 2025GRAIL, Inc. announced that they will report Q4, 2024 results After-Market on Feb 20, 2025Board Change • Feb 05Less than half of directors are independentThere are 5 new directors who have joined the board in the last 3 years. Of these new board members, 1 was an independent director. The company's board is composed of: 1 independent director. 6 non-independent directors. Independent Director Sarah Krevans was the last independent director to join the board, commencing their role in 2024. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity.お知らせ • Jan 14GRAIL, Inc. Announces Patient-Based Outcomes (PRO) Assessing Patient Prospective from the Pathfinder StudyGRAIL, Inc. announced that patient-reported outcomes (PRO) assessing patient perspectives from the PATHFINDER study were published in Lancet Oncology. The PATHFINDER study included secondary and exploratory outcomes with the objective of assessing PRO and perceptions of multi-cancer early detection (MCED) testing. PRO assessment was conducted for eligible PATHFINDER study participants with either a cancer signal detected (CSD) or no cancer signal detected (NCSD) over a 12-month follow-up period. In the PATHFINDER study, general anxiety, distress and uncertainty after results disclosure, health-related quality of life, satisfaction with the Galleri® test, and intent towards guideline-recommended screening and repeat MCED testing were assessed. Three instruments used to assess PRO included an adapted Multidimensional Impact of Cancer Risk Assessment (MICRA) for distress, uncertainty and positive experience at MCED test result disclosure, PRO Measurement Information System (PROMIS) Anxiety short-form for anxiety symptoms, the Short Form 12-Item Health Survey (SF-12v2) for health-related quality of Life, and a satisfaction questionnaire. Overall the study demonstrated minimal patient distress associated with MCED testing. Most participants with a NCSD result responded that they were "relieved about my test result." The negative patient-reported impacts associated with a CSD test result were small and returned to baseline within 12 months. High overall satisfaction with the MCED test was reported across participant groups regardless of signal detection status and eventual diagnosis. Most participants reported they were " likely"/"very likely" to adhere to future guideline recommended screening tests as recommended by their healthcare provider.Recent Insider Transactions • Nov 21Chief Financial Officer recently sold €404k worth of stockOn the 18th of November, Aaron Freidin sold around 30k shares on-market at roughly €13.26 per share. This transaction amounted to 42% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth €1.6m. Aaron has been a net seller over the last 12 months, reducing personal holdings by €632k.お知らせ • Nov 19GRAIL Announces First Patient Tested With Blood-Based Assay in Global Phase 3 Adjuvant Lung Cancer StudyGRAIL, Inc. announced that the first patient has been tested for eligibility with the investigational GRAIL Non-Small Cell Lung Cancer (NSCLC) ctDNA Assay in the global TROPION-Lung12 Phase 3 study evaluating adjuvant treatment regimens in patients with Stage I adenocarcinoma NSCLC. The study is sponsored by AstraZeneca in collaboration with Daiichi Sankyo. The study, which is being conducted under an FDA-approved Investigational Device Exemption application, held by GRAIL, leverages GRAIL's targeted methylation platform to detect ctDNA. With GRAIL's blood-only approach, tissue analysis and bespoke panel development are not required, enabling simple integration into pharmaceutical clinical trial workflows. In TROPION-Lung12, patients will be screened with the GRAIL assay prior to surgery to inform eligibility for post-surgery randomization to an adjuvant treatment regimen (NCT06564844). Assay performance was previously reportedin the Journal of Thoracic Oncologyand presented at the 2023 North America Conference on Lung Cancer. In 2022, GRAIL announced a broad strategic collaboration with AstraZeneca to develop and commercialize companion diagnostic (CDx) assays for use with AstraZeneca's therapies. GRAIL is committed to leveraging its blood-based methylation testing for patient care by developing fit-for-purpose diagnostics to enable precision oncology strategies with biopharma partners.Reported Earnings • Nov 14Third quarter 2024 earnings releasedThird quarter 2024 results: US$3.94 loss per share. Net loss: US$125.7m (flat on 3Q 2023). Revenue is forecast to grow 18% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in Europe.お知らせ • Oct 30GRAIL, Inc. to Report Q3, 2024 Results on Nov 12, 2024GRAIL, Inc. announced that they will report Q3, 2024 results After-Market on Nov 12, 2024お知らせ • Oct 25GRAIL, Inc. Presents Initial Results from REFLECTION Real-World Evidence Study of Galleri® Multi-Cancer Early Detection (MCED) Test at the Early Detection of Cancer ConferenceGRAIL, Inc. announced early results from the REFLECTION study, which aims to understand the real-world experience of the Galleri multi-cancer early detection (MCED) test in routine clinical settings. The Galleri test is recommended for adults with an elevated risk for cancer, such as those age 50 or older. In this study, a diverse population of veterans from U.S. Department of Veterans Affairs (VA) sites with toxic exposure but with no symptoms suggestive of cancer were included in study enrollment. Initial results showed that among study participants, the veteran cohort had a cancer signal detection rate consistent with other populations that have received the MCED test. The findings were presented during a presentation at the 2024 Early Detection of Cancer Conference (EDCC). Overall, the cancer signal detection rate in this veteran cohort was 1.30% (37/2854 participants; 95% CI: 0.94% - 1.78%), which is consistent with other populations that have received the MCED test (0.88%1 and 0.95%2). Among the 37 participants with a Cancer Signal Detected (CSD) at the time of analysis, 28 completed 180 days of follow-up, and of these, 12 cancer diagnoses were confirmed. More than half of the cases were identified at early stages (I-III) and the most common cancer signal of origin prediction was lung cancer (7). A positive predictive value (PPV), meaning that the test accurately detects a signal for cancer in someone that has cancer, was 42.9%, which is consistent with PPVs from previous Galleri testing datasets. Additional cancers could be diagnosed during the remainder of the one-year follow-up period. The REFLECTION study (NCT05205967) is a multi-center, prospective, non-interventional, cohort study designed to understand the real-world experience of Galleri in clinical settings. This initial analysis included data from seven VA sites with 180 days of post-test follow-up. A total of 2,924 veterans were enrolled in the study at the time of the analysis and 2,854 are analyzable in these initial study data. Within the veteran cohort with data, 70% of participants had been exposed to one or more toxic environmental or occupational hazards during their service, including open burn pits/airborne hazards, Gulf War-related exposures, Agent Orange, radiation and others. The study included recruitment of veterans aged =22 years. The mean age of the cohort was 60 years old and the cohort was 79% male.お知らせ • Oct 24GRAIL, Inc. Announces the Appointment of Sarah Krevans to Its Board of DirectorsGRAIL, Inc. announced the appointment of Sarah Krevans to its Board of Directors, effective immediately. Ms. Krevans will also serve as a member of the Board’s Audit Committee, Compensation Committee, and Nominating and Governance Committee. Following the appointment of Ms. Krevans, the Board will be composed of five directors, four of whom are independent. Ms. Krevans served as president and CEO of Sutter Health from 2016 to 2022. She was responsible for Sutter Health’s integrated network of 14,000 clinicians, 24 hospitals, outpatient services, research facilities, and home health and hospice care. Under her leadership, Ms. Krevans advanced clinical programs, innovation, and digital health to make healthcare more accessible for patients. Previously, Ms. Krevans served as chief operating officer, and regional executive officer and president of the Sutter Health Sacramento Sierra Region. She also held executive roles at Kaiser Permanente and served as deputy director of Maine’s Bureau of Medical Services and acting director of Medicaid, health planning and licensure programs. Ms. Krevans’ experience as a board member includes serving on many not-for-profit boards and as Chair of the California Association of Hospitals. She currently serves on the board of the Acacium Group and is the incoming Chair of CaringBridge. Ms. Krevans earned master’s degrees in business administration and in public health from the University of California, Berkeley, and a bachelor’s degree from Boston University. Ms. Krevans will serve as a Class II director, for a term expiring at the annual meeting of stockholders to be held in 2026 or until her earlier death, resignation or removal.Recent Insider Transactions • Oct 20CEO & Director recently sold €1.6m worth of stockOn the 15th of October, Robert Ragusa sold around 123k shares on-market at roughly €12.86 per share. This transaction amounted to 51% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Robert's only on-market trade for the last 12 months.お知らせ • Sep 03European Court of Justice Rules in Favor of Illumina, Inc. in Relation to Relation to the European Commission's Acquisition of GRAILIllumina, Inc. announced that it welcomes the European Court of Justice's (ECJ's) judgment ruling that the European Commission did not have jurisdiction over Illumina's acquisition of GRAIL. Judgment confirms Illumina's longstanding view that the European Commission exceeded its authority by asserting jurisdiction over this merger. The basis for the 432 million euro fine has now been removed and will no longer be payable. Following Illumina's spin-off of GRAIL in June 2024, GRAIL is now an independent public company. Illumina maintains a minority share of 14.5% in GRAIL, and Illumina will continue to support the company with its sequencing technology and suite of services. In the US, the FTC Commissioners dismissed the case against Illumina and GRAIL on August 15, 2024, following the successful spinoff of GRAIL, thus ending the U.S proceedings.お知らせ • Aug 30GRAIL, Inc. Announces Results of Galleri Multi-Cancer Early Detection Blood Test in Prostate Cancer Published in JCO Precision OncologyGRAIL, Inc. announced that detailed findings of the performance of its Galleri multi-cancer early detection (MCED) test in prostate cancer were published in JCO Precision Oncology. The data support the clinical performance of the Galleri test to preferentially screen for aggressive, clinically significant prostate cancer as compared to slow-growing (indolent) cases in the Circulating Cell-free Genome Atlas (CCGA) and PATHFINDER studies. The published data is from an analysis of 420 prostate cancer patients identified in the independent clinical validation portion (substudy 3) of the multi-center, case-control observational study Circulating Cell-freeGenome Atlas (CCGA) study and 18 cases from the prospective intended-use PATHFINDER study. The data were previously presented at the American Association for Cancer Research (AACR) Annual Meeting in March 2024. Results from this analysis showed that of the prostate cancers that were detected by the MCED test, most were clinically significant (93% were intermediate or high grade and 67% were stage III or IV). For detected prostate cancers, the cancer signal of origin (CSO) prediction accuracy was > 90%. Detectability for stage I and II cancers were 4.2% across both studies combined, which is expected with low shedding prostate cancer tumor fraction and is consistent with cfDNA literature in prostate cancer. Test sensitivity of prostate cancer for all stages was 11.2% in substudy CCGA-3. Notably, the MCED test detected no low-grade cancers, 1.9% of intermediate-grade cancers, and only 4.2% of stage I and II cancers across both studies combined. Of the detected cases, 93% were Gleason grade groups 3-5. This analysis demonstrates the MCED test preferentially detects high-grade, clinically significant prostate cancer. This is important because an MCED test, when used in addition to standard-of-care screening, should not exacerbate overdiagnosis of indolent cancers. These findings also suggest that individuals with a cancer signal detected and a prostate CSO prediction should undergo a prompt diagnostic evaluation to determine the presence of aggressive disease for which treatment is generally indicated. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of No Cancer Signal detected requires confirmatory diagnostic evaluation by medically established procedures (e.g. imaging) to confirm cancer. If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. false-positive prostate cancer is expected to detect cancer signals, and the cancer signal is located.Recent Insider Transactions • Aug 29President recently sold €1.1m worth of stockOn the 21st of August, Joshua Ofman sold around 74k shares on-market at roughly €14.60 per share. This transaction amounted to 51% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Joshua's only on-market trade for the last 12 months.Board Change • Aug 29No independent directorsFollowing the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 12 non-independent directors. Director Bill Chase was the last director to join the board, commencing their role in 2024. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.Reported Earnings • Aug 15Second quarter 2024 earnings releasedSecond quarter 2024 results: US$51.06 loss per share. Net loss: US$1.59b (flat on 2Q 2023).お知らせ • Aug 14GRAIL, Inc. Reports Impairment Charges for the Second Quarter Ended June 30, 2024GRAIL, Inc. reported impairment charges for the second quarter ended June 30, 2024. For the quarter, the company reported goodwill and intangible impairment of $1,420,936,000.お知らせ • Aug 01GRAIL, Inc. to Report Q2, 2024 Results on Aug 13, 2024GRAIL, Inc. announced that they will report Q2, 2024 results at 4:00 PM, US Eastern Standard Time on Aug 13, 2024お知らせ • Jul 15GRAIL, Inc. Provides an Update on the PATHFINDER 2 and NHS-Galleri Registrational Clinical Trials Evaluating the Galleri® Multi-Cancer Early Detection (MCED) TestGRAIL, Inc. provided an update on the PATHFINDER 2 and NHS-Galleri registrational clinical trials evaluating the Galleri® multi-cancer early detection (MCED) test. GRAIL has completed the PATHFINDER 2 study's planned enrollment of more than 35,000 participants who are eligible for guideline-recommended cancer screening at more than 30 healthcare institutions in North America. In addition, GRAIL has completed the third and final round of study visits for the NHS-Galleri trial, which enrolled more than 140,000 participants. The PATHFINDER 2 and NHS-Galleri studies will significantly expand the company's existing clinical validation and performance evidence for the Galleri test. By supplementing robust clinical evidence program with more than 35,000 participants in the U.S. for PATHFINDER 2 and over 140,000 participants in England for NHS-Galleri, the company will continue generation of additional performance, safety, and clinical utility data," said Bob Ragusa, Chief Executive Officer at GRAIL. "Both studies were designed to enroll a diverse participant population, representative of socio-economic, ethnicity, gender and age differences, and the company is proud of the diversity of the study populations. The data from these studies, as well as supplemental data from other clinical studies, will support premarket approval application submission for Galleri to the FDA, which is currently in process with a modular submission under a Breakthrough Device Designation from the FDA. The company looks forward to seeing results from the first 25,000 individuals enrolled in the PATHFINDER 2 study in the second half of 2025 and final results from the NHS-Galleri trial in 2026.Board Change • Jun 27No independent directorsThere is 1 new director who has joined the board in the last 3 years. The new board member was not an independent director. The company's board is composed of: 1 new director. 9 experienced directors. 2 highly experienced directors. No independent directors (11 non-independent directors). Director Chuck Dadswell was the last director to join the board, commencing their role in 2024. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Insufficient board refreshment.株主還元NL0DE BiotechsDE 市場7D0%0.9%3.2%1Yn/a-12.2%2.5%株主還元を見る業界別リターン: NL0がGerman Biotechs業界に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。リターン対市場: NL0 German市場に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。価格変動Is NL0's price volatile compared to industry and market?NL0 volatilityNL0 Average Weekly Movementn/aBiotechs Industry Average Movement8.7%Market Average Movement6.1%10% most volatile stocks in DE Market13.6%10% least volatile stocks in DE Market2.7%安定した株価: NL0の株価は、 German市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 過去 1 年間のNL0のボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO（最高経営責任者ウェブサイト2015910Bob Ragusagrail.com商業段階のヘルスケア企業であるGRAIL, Inc.は、米国内外で複数のがん早期発見検査とサービスを提供している。50歳以上の無症状者を対象としたがんスクリーニング検査「Galleri」や、臨床的にがんが疑われる患者の診断解決を早めるためのがん検査用診断補助薬「DAC」を提供している。また、進行中の臨床試験、パイロットテスト、研究、治療法開発のサポートを含む開発サービスも提供している。さらに、最小残存病変の診断後検査も開発している。同社は2015年に法人化され、カリフォルニア州メンローパークに本社を置いている。もっと見るGRAIL, Inc. 基礎のまとめGRAIL の収益と売上を時価総額と比較するとどうか。NL0 基礎統計学時価総額€2.48b収益（TTM）-€340.61m売上高(TTM)€134.51m18.5xP/Sレシオ-7.3xPER（株価収益率NL0 は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計NL0 損益計算書（TTM）収益US$156.12m売上原価US$79.18m売上総利益US$76.94mその他の費用US$472.26m収益-US$395.32m直近の収益報告Mar 31, 2026次回決算日該当なし一株当たり利益（EPS）-9.21グロス・マージン49.28%純利益率-253.22%有利子負債／自己資本比率0%NL0 の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/23 03:05終値2026/04/13 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋GRAIL, Inc. 8 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。11 アナリスト機関Catherine Ramsey SchulteBairdKyle MiksonCanaccord GenuitySubhalaxmi NambiGuggenheim Securities, LLC8 その他のアナリストを表示
お知らせ • Apr 30GRAIL, Inc., Annual General Meeting, Jun 18, 2026GRAIL, Inc., Annual General Meeting, Jun 18, 2026.
お知らせ • Apr 23GRAIL, Inc. to Report Q1, 2026 Results on May 05, 2026GRAIL, Inc. announced that they will report Q1, 2026 results After-Market on May 05, 2026
お知らせ • Apr 08GRAIL, Inc. Announces Integration of Galleri Test into Epic Electronic Health Record PlatformGRAIL, Inc. announced a collaboration with Epic to bring the Galleri multi-cancer early detection test into one of the nation's most widely used electronic health record platforms, supporting broader adoption across health systems in the United States. Epic is a leading EHR platform used by many of the largest and most advanced health systems. Integration through Epic Aura will allow interested health systems and their healthcare providers to order the Galleri test directly at the point of care, receive results, and manage patient follow-up seamlessly within their existing native EHR and within their existing clinical workflows. Through this integration, clinicians using Epic can access the Galleri test within their native EHR environment, helping to eliminate administrative burden, reduce manual processes, and improve the overall provider and patient experience. Implementation planning began in the first quarter of 2026, including initial integrations and early adopter programs. GRAIL will work closely with Epic and AWS, the preferred cloud provider for GRAIL, along with any interested health systems, community healthcare providers, and retail health clinics to support workflow alignment, training and deployment success. Broad availability is expected by the end of 2026. The Galleri multi-cancer early detection test is a proactive tool to screen for cancer. With a simple blood draw, Galleri can detect more than 50 types of cancer before symptoms appear — when they can be easier to treat and are potentially curable. Galleri is the only available MCED test with demonstrated performance in patients screened for cancer. The Galleri test increases the number of cancers detected seven-fold when added to recommended screening for breast, cervical, colorectal and lung cancers, and has the lowest false positive rate of any MCED test on the market. The Galleri test doubles the number of cancers detected when added to standard of care cancer screening, and has the lowest false positive rate of any MCED test. When a cancer signal is found, Galleri provides a cancer signal of origin with high accuracy to help guide an efficient diagnostic work-up. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen test, or cervical cancer screening. The Galleri test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older.
お知らせ • Mar 13+ 1 more updateGRAIL, Inc. Announces Chief Executive Officer Changes, Effective June 1, 2026GRAIL, Inc. announced that Bob Ragusa will retire as Chief Executive Officer, effective June 1, 2026. Ragusa will remain on GRAIL's Board until June 1, 2026, and plans to serve in a senior advisory role through March of 2027. GRAIL's Board of Directors has appointed the Company's President, Josh Ofman, MD, MSHS, to serve as GRAIL's Chief Executive Officer upon Ragusa's retirement. Ofman joined GRAIL in 2019 and brings extensive experience in clinical medicine, biopharmaceutical leadership, health policy and precision medicine. He has served on numerous industry Boards, including BIO and the Precision Medicine Coalition. Before joining GRAIL, Ofman spent more than 15 years at Amgen, most recently as Senior Vice President, Global Value, Access and Policy. Earlier in his career, he was a faculty member in the Department of Medicine and Health Services Research at the UCLA School of Medicine and the Division of Digestive Diseases at Cedars-Sinai Medical Center, and served as Senior Vice President of Zynx Health Inc., a subsidiary of Cerner Corp.
Reported Earnings • Feb 23Full year 2025 earnings released: US$11.11 loss per share (vs US$63.54 loss in FY 2024)Full year 2025 results: US$11.11 loss per share (improved from US$63.54 loss in FY 2024). Revenue: US$147.2m (up 17% from FY 2024). Net loss: US$408.4m (loss narrowed 80% from FY 2024). Revenue is forecast to grow 22% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Europe.
お知らせ • Feb 20GRAIL, Inc. Announces NHS Galleri Trial Demonstrates A Substantial Reduction in Stage IV Cancer Diagnoses, Increased Stage I and II Detection of Deadly Cancers, and Four-Fold Higher Cancer Detection RateGRAIL, Inc. announced topline results from the landmark, randomized, controlled NHS-Galleri trial, which evaluated annual multi-cancer screening with the Galleri test in England's National Health Service (NHS) over three years in 142,000 demographically representative participants aged 50 to 77. The clinical performance of Galleri has been rigorously established in several studies, and the NHS-Galleri trial was designed to demonstrate population-level impact through the reduction of late stage cancer diagnoses and increased cancer detection rate within the NHS to inform a decision about a national screening program in England. For the US market, the Galleri premarket approval application pending review by the FDA also includes metrics from the NHS-Galleri trial that are focused on test performance, clinical validation, and the clinical benefit of detection at Stages I through III, including reduction in Stage IV cancer diagnoses. Key trial results include: The primary endpoint of statistically significant Stage III-IV reduction was not observed. However, there was a favorable trend toward fewer Stage III-IV cancers in a pre-specified group of 12 deadly cancers in the intervention arm after the prevalent screening round. Adding Galleri to standard of care screening resulted in a substantial and clinically meaningful reduction in Stage IV diagnoses compared with standard of care alone across the pre-specified group of 12 deadly cancers. Stage IV diagnoses in these cancers decreased with each year of sequential screening, with a greater than 20% reduction in the second and third rounds. Similar reductions were observed across all cancers. Annual screening with the Galleri test plus standard of care screening resulted in a four-fold improvement in the overall cancer detection rate compared to standard of care screening alone in England for breast, colorectal, cervical and high risk lung cancer. Substantial increase in the absolute number of Stage I-II cancers in the 12 pre-specified deadly cancer types that are typically found in late stages were observed in the intervention arm. Screening with the Galleri test resulted in a substantial reduction in the number of cancers detected clinically through emergency presentation, which are associated with significantly higher mortality and healthcare costs. The Galleri test's performance – positive predictive value (PPV), specificity and Cancer Signal of Origin (CSO) accuracy – was consistent with the range previously reported from GRAIL's North American studies. Importantly, no serious safety concerns were reported in participants who received the Galleri test in the NHS-Galleri trial. Additional analyses are underway to better understand these rich data, and detailed results will be submitted for presentation at the ASCO 2026 Annual Meeting. Of note, there was a higher than anticipated incidence of Stage III cancers in the NHS-Galleri trial. In both the US and the NHS data, the time to diagnostic resolution appears to improve over time as physicians gain experience with the Galleri test and diagnostic workup. The number and distribution of cancer stages across screening rounds suggests the potential for a stronger effect with longer follow up as data matures, and GRAIL plans to extend the trial's follow up period by 6-12 months.
お知らせ • Apr 30GRAIL, Inc., Annual General Meeting, Jun 18, 2026GRAIL, Inc., Annual General Meeting, Jun 18, 2026.
お知らせ • Apr 23GRAIL, Inc. to Report Q1, 2026 Results on May 05, 2026GRAIL, Inc. announced that they will report Q1, 2026 results After-Market on May 05, 2026
お知らせ • Apr 08GRAIL, Inc. Announces Integration of Galleri Test into Epic Electronic Health Record PlatformGRAIL, Inc. announced a collaboration with Epic to bring the Galleri multi-cancer early detection test into one of the nation's most widely used electronic health record platforms, supporting broader adoption across health systems in the United States. Epic is a leading EHR platform used by many of the largest and most advanced health systems. Integration through Epic Aura will allow interested health systems and their healthcare providers to order the Galleri test directly at the point of care, receive results, and manage patient follow-up seamlessly within their existing native EHR and within their existing clinical workflows. Through this integration, clinicians using Epic can access the Galleri test within their native EHR environment, helping to eliminate administrative burden, reduce manual processes, and improve the overall provider and patient experience. Implementation planning began in the first quarter of 2026, including initial integrations and early adopter programs. GRAIL will work closely with Epic and AWS, the preferred cloud provider for GRAIL, along with any interested health systems, community healthcare providers, and retail health clinics to support workflow alignment, training and deployment success. Broad availability is expected by the end of 2026. The Galleri multi-cancer early detection test is a proactive tool to screen for cancer. With a simple blood draw, Galleri can detect more than 50 types of cancer before symptoms appear — when they can be easier to treat and are potentially curable. Galleri is the only available MCED test with demonstrated performance in patients screened for cancer. The Galleri test increases the number of cancers detected seven-fold when added to recommended screening for breast, cervical, colorectal and lung cancers, and has the lowest false positive rate of any MCED test on the market. The Galleri test doubles the number of cancers detected when added to standard of care cancer screening, and has the lowest false positive rate of any MCED test. When a cancer signal is found, Galleri provides a cancer signal of origin with high accuracy to help guide an efficient diagnostic work-up. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen test, or cervical cancer screening. The Galleri test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older.
お知らせ • Mar 13+ 1 more updateGRAIL, Inc. Announces Chief Executive Officer Changes, Effective June 1, 2026GRAIL, Inc. announced that Bob Ragusa will retire as Chief Executive Officer, effective June 1, 2026. Ragusa will remain on GRAIL's Board until June 1, 2026, and plans to serve in a senior advisory role through March of 2027. GRAIL's Board of Directors has appointed the Company's President, Josh Ofman, MD, MSHS, to serve as GRAIL's Chief Executive Officer upon Ragusa's retirement. Ofman joined GRAIL in 2019 and brings extensive experience in clinical medicine, biopharmaceutical leadership, health policy and precision medicine. He has served on numerous industry Boards, including BIO and the Precision Medicine Coalition. Before joining GRAIL, Ofman spent more than 15 years at Amgen, most recently as Senior Vice President, Global Value, Access and Policy. Earlier in his career, he was a faculty member in the Department of Medicine and Health Services Research at the UCLA School of Medicine and the Division of Digestive Diseases at Cedars-Sinai Medical Center, and served as Senior Vice President of Zynx Health Inc., a subsidiary of Cerner Corp.
Reported Earnings • Feb 23Full year 2025 earnings released: US$11.11 loss per share (vs US$63.54 loss in FY 2024)Full year 2025 results: US$11.11 loss per share (improved from US$63.54 loss in FY 2024). Revenue: US$147.2m (up 17% from FY 2024). Net loss: US$408.4m (loss narrowed 80% from FY 2024). Revenue is forecast to grow 22% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Europe.
お知らせ • Feb 20GRAIL, Inc. Announces NHS Galleri Trial Demonstrates A Substantial Reduction in Stage IV Cancer Diagnoses, Increased Stage I and II Detection of Deadly Cancers, and Four-Fold Higher Cancer Detection RateGRAIL, Inc. announced topline results from the landmark, randomized, controlled NHS-Galleri trial, which evaluated annual multi-cancer screening with the Galleri test in England's National Health Service (NHS) over three years in 142,000 demographically representative participants aged 50 to 77. The clinical performance of Galleri has been rigorously established in several studies, and the NHS-Galleri trial was designed to demonstrate population-level impact through the reduction of late stage cancer diagnoses and increased cancer detection rate within the NHS to inform a decision about a national screening program in England. For the US market, the Galleri premarket approval application pending review by the FDA also includes metrics from the NHS-Galleri trial that are focused on test performance, clinical validation, and the clinical benefit of detection at Stages I through III, including reduction in Stage IV cancer diagnoses. Key trial results include: The primary endpoint of statistically significant Stage III-IV reduction was not observed. However, there was a favorable trend toward fewer Stage III-IV cancers in a pre-specified group of 12 deadly cancers in the intervention arm after the prevalent screening round. Adding Galleri to standard of care screening resulted in a substantial and clinically meaningful reduction in Stage IV diagnoses compared with standard of care alone across the pre-specified group of 12 deadly cancers. Stage IV diagnoses in these cancers decreased with each year of sequential screening, with a greater than 20% reduction in the second and third rounds. Similar reductions were observed across all cancers. Annual screening with the Galleri test plus standard of care screening resulted in a four-fold improvement in the overall cancer detection rate compared to standard of care screening alone in England for breast, colorectal, cervical and high risk lung cancer. Substantial increase in the absolute number of Stage I-II cancers in the 12 pre-specified deadly cancer types that are typically found in late stages were observed in the intervention arm. Screening with the Galleri test resulted in a substantial reduction in the number of cancers detected clinically through emergency presentation, which are associated with significantly higher mortality and healthcare costs. The Galleri test's performance – positive predictive value (PPV), specificity and Cancer Signal of Origin (CSO) accuracy – was consistent with the range previously reported from GRAIL's North American studies. Importantly, no serious safety concerns were reported in participants who received the Galleri test in the NHS-Galleri trial. Additional analyses are underway to better understand these rich data, and detailed results will be submitted for presentation at the ASCO 2026 Annual Meeting. Of note, there was a higher than anticipated incidence of Stage III cancers in the NHS-Galleri trial. In both the US and the NHS data, the time to diagnostic resolution appears to improve over time as physicians gain experience with the Galleri test and diagnostic workup. The number and distribution of cancer stages across screening rounds suggests the potential for a stronger effect with longer follow up as data matures, and GRAIL plans to extend the trial's follow up period by 6-12 months.
お知らせ • Feb 16GRAIL, Inc. to Report Q4, 2025 Results on Feb 19, 2026GRAIL, Inc. announced that they will report Q4, 2025 results After-Market on Feb 19, 2026
お知らせ • Jan 30GRAIL, Inc. Submits FDA Premarket Approval Application for the Galleri®? Multi-Cancer Early Detection TestGRAIL, Inc. 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. The FDA designated the test as a Breakthrough Device in 2018. The PMA submission is focused on the test performance and safety results from 25,490 consented participants in the US-based PATHFINDER 2 study with one year of follow up and from the prevalent screening round (first year) of the NHS-Galleri trial, the largest, and only, randomized, controlled trial of any MCED test in an intended use population. The submission is also supported by a bridging analysis to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated PMA version that has been submitted to the FDA for premarket approval. About the NHS-Galleri trial (NCT05611632) The NHS-Galleri trial is the first and only prospective, randomized, controlled trial to assess the clinical utility and performance of a multi-cancer early detection test for population screening when added to standard care. PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of the Galleri in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States. The primary objectives of the study are 1) to evaluate the safety and performance of theGalleri MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result, and 2) to evaluate the performance of the Galleri MCED test across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy. Participants who receive a cancer signal detected result undergo additional diagnostic testing based on the predicted CSO to determine if a cancer is present.
お知らせ • Jan 15GRAIL, Inc. Provides Earnings Guidance for the Full Year 2025GRAIL, Inc. provided earnings guidance for the full year 2025. Revenue is expected to be between $147 million and $148 million, approximately 17% to 18% growth over 2024.
お知らせ • Nov 14GRAIL, Inc. has filed a Follow-on Equity Offering in the amount of $300 million.GRAIL, Inc. has filed a Follow-on Equity Offering in the amount of $300 million. Security Name: Common Stock Security Type: Common Stock Transaction Features: At the Market Offering
Reported Earnings • Nov 14Third quarter 2025 earnings released: US$2.46 loss per share (vs US$3.94 loss in 3Q 2024)Third quarter 2025 results: US$2.46 loss per share (improved from US$3.94 loss in 3Q 2024). Revenue: US$36.2m (up 26% from 3Q 2024). Net loss: US$89.0m (loss narrowed 29% from 3Q 2024). Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Europe.
お知らせ • Nov 08GRAIL, Inc. announced that it has received $324.999987 million in funding from Samsung Electronics Co., Ltd., Samsung Electronics Singapore Pte. Ltd., Samsung C&T CorporationOn November 7, 2025, GRAIL, Inc closed the transaction. The transaction included participation from 17 investors.
お知らせ • Oct 30GRAIL, Inc. to Report Q3, 2025 Results on Nov 12, 2025GRAIL, Inc. announced that they will report Q3, 2025 results After-Market on Nov 12, 2025
お知らせ • Oct 21Grail, Inc. and University of Oxford to Present Long-Term Data from the Symplify Study Evaluating the Galleri®? Multi-Cancer Early Detection Test in Symptomatic Individuals At the Early Detection of Cancer ConferenceGRAIL, Inc. and the University of Oxford announced that positive long-term results from an extended registry follow-up of the SYMPLIFY study will be presented on Oct. 21 at the Early Detection of Cancer Conference (EDCC) in Portland, Oregon. SYMPLIFY, a prospective observational study, is the first large-scale evaluation of a multi-cancer early detection (MCED) test in individuals who presented with symptoms to primary care and were referred for diagnostic follow-up for suspicion of cancer. In SYMPLIFY, the Galleri®? test was used to assess blood samples from more than 6,000 participants with symptoms of cancer who followed standard diagnostic pathways. However, as a non-interventional study, the results of the tests were unknown to physicians and did not inform the approach to diagnosis. No MCED results were returned to participants or their clinicians during the study. Previous SYMPLIFY results showed potential of MCED testing in people with symptoms suggestive of cancer Most people diagnosed with cancer visit primary care with symptoms before diagnosis1. The fact that, in all but one of the additional patients diagnosed with cancer, a Galleri CSO prediction correctly identified the cancer type, including in many cases where the symptoms were non-specific, further reinforces the value of the Galleri test's CSO capability.
Recent Insider Transactions • Oct 19CEO & Director recently sold €429k worth of stockOn the 15th of October, Robert Ragusa sold around 7k shares on-market at roughly €59.21 per share. This transaction amounted to 3.3% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth €4.3m. Robert has been a net seller over the last 12 months, reducing personal holdings by €3.5m.
お知らせ • Oct 18GRAIL, Inc. Announces Positive Performance and Safety Results from its Registrational Pathfind 2 StudyGRAIL, Inc. announced that positive performance and safety results from its registrational PATHFINDER 2 study are being presented at the European Society for Medical Oncology (ESMO) Congress 20251. The largest interventional study of an MCED test in the United States to date, the prospective PATHFINDER 2 study includes 35,878 enrolled participants across the United States and Canada in a broad, intended-use population of adults aged 50 and older with no clinical pinpoint of cancer. Results were presented from a pre-specified analysis of the first 25,578 participants with at least 12 months of follow-up as of Dec. 31, 2024. The likelihood of receiving a cancer diagnosis following a positive test result (positive predictive value) was 61.6%, substantially higher than in the previous PATHFINDER study of Galleri. Since PATHFINDER 2 is a prospective clinical trial where the cancer status of participants is unknown at the outset, episode sensitivity - the ability to detect cancer that could be confirmed within 12 months after the blood draw - is a performance measure of the study. Data from this study will be submitted to the U.S. Food and Drug Administration (FDA) as part of the Galleri premium approval (PMA) application, along with data from the prevalent screening round of the NHS-Galleri trial. In addition, GRAIL will submit to the FDA a bridging analysis to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated version that GRAIL plans to submit to the FDA for premarket approval. The primary objectives of the study are 1) to evaluate the safety and performance of the Galleri MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result, and 2) to evaluate the performance of the GalleriMCED test across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs, and symptoms. A test result of No Cancer Signal detected does not rule out cancer. A test result of Cancer Signal detected requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirmatory diagnostic evaluation by medically establish procedures (e.g., Imaging) to confirm cancer. The Galleri test was developed -- and its performance characteristics were determined -- by GRAIL. The Galleri test has not been cleared or approved by the Food and Drug Administration. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about GRAIL, Inc. (the "Company"), include the benefits and use of the Galleri test, the potential of the Galleri MCED tests, expectations regarding the final results of the PATHFINDER 2 Study, upcoming events and presentations, the timeline and results of a bridging analysis to the FDA, the applicability of the Galleri test, and the applicability of the Galler test, and the timeline for completion of the PMO and the timeline for completion of The PMO and the first phase of the study.
お知らせ • Oct 17GRAIL, Inc. announced that it expects to receive $110.000075 million in funding from Samsung Electronics Co., Ltd., Samsung Electronics Singapore Pte. Ltd and Samsung C&T CorporationGRAIL, Inc. entered into a stock purchase agreement for issuance of 1,570,308 common shares at a price of $70.05 per share for gross proceeds of $110,000,075.4 on October 16, 2025. The transaction included participation from new investors Samsung Electronics Co., Ltd., Samsung Electronics Singapore Pte. Ltd. and Samsung C&T Corporation. The Private Placement is exempt from the registration requirements of the Securities Act, pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) and/or Rule 506 of Regulation D under the Securities Act and in reliance on similar exemptions under applicable state laws. The transaction closing is subject to regulatory approvals.
Recent Insider Transactions • Oct 10President recently sold €4.3m worth of stockOn the 6th of October, Joshua Ofman sold around 81k shares on-market at roughly €53.37 per share. This transaction amounted to 33% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Joshua has been a net seller over the last 12 months, reducing personal holdings by €6.0m.
Reported Earnings • Aug 13Second quarter 2025 earnings released: US$3.19 loss per share (vs US$51.06 loss in 2Q 2024)Second quarter 2025 results: US$3.19 loss per share (improved from US$51.06 loss in 2Q 2024). Revenue: US$35.5m (up 11% from 2Q 2024). Net loss: US$114.0m (loss narrowed 93% from 2Q 2024). Revenue is forecast to grow 19% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Europe.
お知らせ • Aug 13GRAIL, Inc. Reports Impairment Charges for the Second Quarter Ended June 30, 2025GRAIL, Inc. reported impairment charges for the second quarter ended June 30, 2025. For the quarter, the company reported goodwill and intangible impairment of $28,000,000 against $1,420,936,000 a year ago.
お知らせ • Jul 30GRAIL, Inc. to Report Q2, 2025 Results on Aug 12, 2025GRAIL, Inc. announced that they will report Q2, 2025 results After-Market on Aug 12, 2025
お知らせ • Jun 30+ 4 more updatesGRAIL, Inc.(NasdaqGS:GRAL) dropped from Russell Midcap Value IndexGRAIL, Inc.(NasdaqGS:GRAL) dropped from Russell Midcap Value Index
お知らせ • Jun 18GRAIL, Inc. Announces Positive Top-Line Results from The Galleri PATHFINDER 2 Registrational StudyGRAIL, Inc. announced positive top-line performance and safety results from the pre-specified analysis of the first 25,578 participants in GRAIL's registrational PATHFINDER 2 study. PATHFINDER 2 was initiated in 2021 to evaluate the safety and performance of the Galleri®? multi-cancer early detection (MCED) test when added to standard of care single cancer screening in 35,878 adults over 50 years of age with no clinical suspicion of cancer. PATHFINDER 2 study results will be submitted to the U.S. Food and Drug Administration (FDA) as part of the Galleri premarket approval application (PMA), along with data from the prevalent screening round of the NHS-Galleri trial. In addition, GRAIL will submit to the FDA bridging analyses to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated version that GRAIL plans to submit to the FDA for premarket approval. The PMA for Galleri is currently in process with a modular submission under a Breakthrough Device Designation from the FDA. GRAIL expects to complete the PMA modular submission in the first half of 2026. Detailed results from the PATHFINDER 2 Study (NCT05155605). PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States. The primary objectives of the study are 1) to evaluate the safety and effectiveness of the Galleri MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result, and 2) to evaluate the performance of the Galleri MCED tests across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy. Participants who receive a cancer signal detected result undergo additional diagnostic testing based on the predicted CSO to determine if a cancer is present. Use of the test is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs, and symptoms. A test result of No Cancer Signal detected does not rule out cancer. A test result of Cancer Signal detected requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirmatory diagnostic evaluation by medically establish procedures (e.g., Imaging) to confirmatory diagnostic evaluation of cancer, including due to the cancer being located in a different part of the body. false negative (a cancer signal not detected when cancer is present) test results do occur. Rx only. The GRAIL clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed -- and its performance characteristics were determined -- by GRAIL. The Galleri test has not been cleared or approved by the Food and Drug Administration. The Galleri test was regulated under CLIA to perform high-complexity testing.
お知らせ • Apr 30GRAIL, Inc. to Report Q1, 2025 Results on May 13, 2025GRAIL, Inc. announced that they will report Q1, 2025 results After-Market on May 13, 2025
お知らせ • Apr 17GRAIL, Inc., Annual General Meeting, May 29, 2025GRAIL, Inc., Annual General Meeting, May 29, 2025.
Reported Earnings • Feb 22Full year 2024 earnings releasedFull year 2024 results: US$63.54 loss per share. Revenue: US$125.6m (up 35% from FY 2023). Net loss: US$2.03b (loss widened 38% from FY 2023). Revenue is forecast to grow 14% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in Europe.
お知らせ • Feb 13GRAIL, Inc. to Report Q4, 2024 Results on Feb 20, 2025GRAIL, Inc. announced that they will report Q4, 2024 results After-Market on Feb 20, 2025
Board Change • Feb 05Less than half of directors are independentThere are 5 new directors who have joined the board in the last 3 years. Of these new board members, 1 was an independent director. The company's board is composed of: 1 independent director. 6 non-independent directors. Independent Director Sarah Krevans was the last independent director to join the board, commencing their role in 2024. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity.
お知らせ • Jan 14GRAIL, Inc. Announces Patient-Based Outcomes (PRO) Assessing Patient Prospective from the Pathfinder StudyGRAIL, Inc. announced that patient-reported outcomes (PRO) assessing patient perspectives from the PATHFINDER study were published in Lancet Oncology. The PATHFINDER study included secondary and exploratory outcomes with the objective of assessing PRO and perceptions of multi-cancer early detection (MCED) testing. PRO assessment was conducted for eligible PATHFINDER study participants with either a cancer signal detected (CSD) or no cancer signal detected (NCSD) over a 12-month follow-up period. In the PATHFINDER study, general anxiety, distress and uncertainty after results disclosure, health-related quality of life, satisfaction with the Galleri® test, and intent towards guideline-recommended screening and repeat MCED testing were assessed. Three instruments used to assess PRO included an adapted Multidimensional Impact of Cancer Risk Assessment (MICRA) for distress, uncertainty and positive experience at MCED test result disclosure, PRO Measurement Information System (PROMIS) Anxiety short-form for anxiety symptoms, the Short Form 12-Item Health Survey (SF-12v2) for health-related quality of Life, and a satisfaction questionnaire. Overall the study demonstrated minimal patient distress associated with MCED testing. Most participants with a NCSD result responded that they were "relieved about my test result." The negative patient-reported impacts associated with a CSD test result were small and returned to baseline within 12 months. High overall satisfaction with the MCED test was reported across participant groups regardless of signal detection status and eventual diagnosis. Most participants reported they were " likely"/"very likely" to adhere to future guideline recommended screening tests as recommended by their healthcare provider.
Recent Insider Transactions • Nov 21Chief Financial Officer recently sold €404k worth of stockOn the 18th of November, Aaron Freidin sold around 30k shares on-market at roughly €13.26 per share. This transaction amounted to 42% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth €1.6m. Aaron has been a net seller over the last 12 months, reducing personal holdings by €632k.
お知らせ • Nov 19GRAIL Announces First Patient Tested With Blood-Based Assay in Global Phase 3 Adjuvant Lung Cancer StudyGRAIL, Inc. announced that the first patient has been tested for eligibility with the investigational GRAIL Non-Small Cell Lung Cancer (NSCLC) ctDNA Assay in the global TROPION-Lung12 Phase 3 study evaluating adjuvant treatment regimens in patients with Stage I adenocarcinoma NSCLC. The study is sponsored by AstraZeneca in collaboration with Daiichi Sankyo. The study, which is being conducted under an FDA-approved Investigational Device Exemption application, held by GRAIL, leverages GRAIL's targeted methylation platform to detect ctDNA. With GRAIL's blood-only approach, tissue analysis and bespoke panel development are not required, enabling simple integration into pharmaceutical clinical trial workflows. In TROPION-Lung12, patients will be screened with the GRAIL assay prior to surgery to inform eligibility for post-surgery randomization to an adjuvant treatment regimen (NCT06564844). Assay performance was previously reportedin the Journal of Thoracic Oncologyand presented at the 2023 North America Conference on Lung Cancer. In 2022, GRAIL announced a broad strategic collaboration with AstraZeneca to develop and commercialize companion diagnostic (CDx) assays for use with AstraZeneca's therapies. GRAIL is committed to leveraging its blood-based methylation testing for patient care by developing fit-for-purpose diagnostics to enable precision oncology strategies with biopharma partners.
Reported Earnings • Nov 14Third quarter 2024 earnings releasedThird quarter 2024 results: US$3.94 loss per share. Net loss: US$125.7m (flat on 3Q 2023). Revenue is forecast to grow 18% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in Europe.
お知らせ • Oct 30GRAIL, Inc. to Report Q3, 2024 Results on Nov 12, 2024GRAIL, Inc. announced that they will report Q3, 2024 results After-Market on Nov 12, 2024
お知らせ • Oct 25GRAIL, Inc. Presents Initial Results from REFLECTION Real-World Evidence Study of Galleri® Multi-Cancer Early Detection (MCED) Test at the Early Detection of Cancer ConferenceGRAIL, Inc. announced early results from the REFLECTION study, which aims to understand the real-world experience of the Galleri multi-cancer early detection (MCED) test in routine clinical settings. The Galleri test is recommended for adults with an elevated risk for cancer, such as those age 50 or older. In this study, a diverse population of veterans from U.S. Department of Veterans Affairs (VA) sites with toxic exposure but with no symptoms suggestive of cancer were included in study enrollment. Initial results showed that among study participants, the veteran cohort had a cancer signal detection rate consistent with other populations that have received the MCED test. The findings were presented during a presentation at the 2024 Early Detection of Cancer Conference (EDCC). Overall, the cancer signal detection rate in this veteran cohort was 1.30% (37/2854 participants; 95% CI: 0.94% - 1.78%), which is consistent with other populations that have received the MCED test (0.88%1 and 0.95%2). Among the 37 participants with a Cancer Signal Detected (CSD) at the time of analysis, 28 completed 180 days of follow-up, and of these, 12 cancer diagnoses were confirmed. More than half of the cases were identified at early stages (I-III) and the most common cancer signal of origin prediction was lung cancer (7). A positive predictive value (PPV), meaning that the test accurately detects a signal for cancer in someone that has cancer, was 42.9%, which is consistent with PPVs from previous Galleri testing datasets. Additional cancers could be diagnosed during the remainder of the one-year follow-up period. The REFLECTION study (NCT05205967) is a multi-center, prospective, non-interventional, cohort study designed to understand the real-world experience of Galleri in clinical settings. This initial analysis included data from seven VA sites with 180 days of post-test follow-up. A total of 2,924 veterans were enrolled in the study at the time of the analysis and 2,854 are analyzable in these initial study data. Within the veteran cohort with data, 70% of participants had been exposed to one or more toxic environmental or occupational hazards during their service, including open burn pits/airborne hazards, Gulf War-related exposures, Agent Orange, radiation and others. The study included recruitment of veterans aged =22 years. The mean age of the cohort was 60 years old and the cohort was 79% male.
お知らせ • Oct 24GRAIL, Inc. Announces the Appointment of Sarah Krevans to Its Board of DirectorsGRAIL, Inc. announced the appointment of Sarah Krevans to its Board of Directors, effective immediately. Ms. Krevans will also serve as a member of the Board’s Audit Committee, Compensation Committee, and Nominating and Governance Committee. Following the appointment of Ms. Krevans, the Board will be composed of five directors, four of whom are independent. Ms. Krevans served as president and CEO of Sutter Health from 2016 to 2022. She was responsible for Sutter Health’s integrated network of 14,000 clinicians, 24 hospitals, outpatient services, research facilities, and home health and hospice care. Under her leadership, Ms. Krevans advanced clinical programs, innovation, and digital health to make healthcare more accessible for patients. Previously, Ms. Krevans served as chief operating officer, and regional executive officer and president of the Sutter Health Sacramento Sierra Region. She also held executive roles at Kaiser Permanente and served as deputy director of Maine’s Bureau of Medical Services and acting director of Medicaid, health planning and licensure programs. Ms. Krevans’ experience as a board member includes serving on many not-for-profit boards and as Chair of the California Association of Hospitals. She currently serves on the board of the Acacium Group and is the incoming Chair of CaringBridge. Ms. Krevans earned master’s degrees in business administration and in public health from the University of California, Berkeley, and a bachelor’s degree from Boston University. Ms. Krevans will serve as a Class II director, for a term expiring at the annual meeting of stockholders to be held in 2026 or until her earlier death, resignation or removal.
Recent Insider Transactions • Oct 20CEO & Director recently sold €1.6m worth of stockOn the 15th of October, Robert Ragusa sold around 123k shares on-market at roughly €12.86 per share. This transaction amounted to 51% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Robert's only on-market trade for the last 12 months.
お知らせ • Sep 03European Court of Justice Rules in Favor of Illumina, Inc. in Relation to Relation to the European Commission's Acquisition of GRAILIllumina, Inc. announced that it welcomes the European Court of Justice's (ECJ's) judgment ruling that the European Commission did not have jurisdiction over Illumina's acquisition of GRAIL. Judgment confirms Illumina's longstanding view that the European Commission exceeded its authority by asserting jurisdiction over this merger. The basis for the 432 million euro fine has now been removed and will no longer be payable. Following Illumina's spin-off of GRAIL in June 2024, GRAIL is now an independent public company. Illumina maintains a minority share of 14.5% in GRAIL, and Illumina will continue to support the company with its sequencing technology and suite of services. In the US, the FTC Commissioners dismissed the case against Illumina and GRAIL on August 15, 2024, following the successful spinoff of GRAIL, thus ending the U.S proceedings.
お知らせ • Aug 30GRAIL, Inc. Announces Results of Galleri Multi-Cancer Early Detection Blood Test in Prostate Cancer Published in JCO Precision OncologyGRAIL, Inc. announced that detailed findings of the performance of its Galleri multi-cancer early detection (MCED) test in prostate cancer were published in JCO Precision Oncology. The data support the clinical performance of the Galleri test to preferentially screen for aggressive, clinically significant prostate cancer as compared to slow-growing (indolent) cases in the Circulating Cell-free Genome Atlas (CCGA) and PATHFINDER studies. The published data is from an analysis of 420 prostate cancer patients identified in the independent clinical validation portion (substudy 3) of the multi-center, case-control observational study Circulating Cell-freeGenome Atlas (CCGA) study and 18 cases from the prospective intended-use PATHFINDER study. The data were previously presented at the American Association for Cancer Research (AACR) Annual Meeting in March 2024. Results from this analysis showed that of the prostate cancers that were detected by the MCED test, most were clinically significant (93% were intermediate or high grade and 67% were stage III or IV). For detected prostate cancers, the cancer signal of origin (CSO) prediction accuracy was > 90%. Detectability for stage I and II cancers were 4.2% across both studies combined, which is expected with low shedding prostate cancer tumor fraction and is consistent with cfDNA literature in prostate cancer. Test sensitivity of prostate cancer for all stages was 11.2% in substudy CCGA-3. Notably, the MCED test detected no low-grade cancers, 1.9% of intermediate-grade cancers, and only 4.2% of stage I and II cancers across both studies combined. Of the detected cases, 93% were Gleason grade groups 3-5. This analysis demonstrates the MCED test preferentially detects high-grade, clinically significant prostate cancer. This is important because an MCED test, when used in addition to standard-of-care screening, should not exacerbate overdiagnosis of indolent cancers. These findings also suggest that individuals with a cancer signal detected and a prostate CSO prediction should undergo a prompt diagnostic evaluation to determine the presence of aggressive disease for which treatment is generally indicated. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of No Cancer Signal detected requires confirmatory diagnostic evaluation by medically established procedures (e.g. imaging) to confirm cancer. If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. false-positive prostate cancer is expected to detect cancer signals, and the cancer signal is located.
Recent Insider Transactions • Aug 29President recently sold €1.1m worth of stockOn the 21st of August, Joshua Ofman sold around 74k shares on-market at roughly €14.60 per share. This transaction amounted to 51% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Joshua's only on-market trade for the last 12 months.
Board Change • Aug 29No independent directorsFollowing the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 12 non-independent directors. Director Bill Chase was the last director to join the board, commencing their role in 2024. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.
Reported Earnings • Aug 15Second quarter 2024 earnings releasedSecond quarter 2024 results: US$51.06 loss per share. Net loss: US$1.59b (flat on 2Q 2023).
お知らせ • Aug 14GRAIL, Inc. Reports Impairment Charges for the Second Quarter Ended June 30, 2024GRAIL, Inc. reported impairment charges for the second quarter ended June 30, 2024. For the quarter, the company reported goodwill and intangible impairment of $1,420,936,000.
お知らせ • Aug 01GRAIL, Inc. to Report Q2, 2024 Results on Aug 13, 2024GRAIL, Inc. announced that they will report Q2, 2024 results at 4:00 PM, US Eastern Standard Time on Aug 13, 2024
お知らせ • Jul 15GRAIL, Inc. Provides an Update on the PATHFINDER 2 and NHS-Galleri Registrational Clinical Trials Evaluating the Galleri® Multi-Cancer Early Detection (MCED) TestGRAIL, Inc. provided an update on the PATHFINDER 2 and NHS-Galleri registrational clinical trials evaluating the Galleri® multi-cancer early detection (MCED) test. GRAIL has completed the PATHFINDER 2 study's planned enrollment of more than 35,000 participants who are eligible for guideline-recommended cancer screening at more than 30 healthcare institutions in North America. In addition, GRAIL has completed the third and final round of study visits for the NHS-Galleri trial, which enrolled more than 140,000 participants. The PATHFINDER 2 and NHS-Galleri studies will significantly expand the company's existing clinical validation and performance evidence for the Galleri test. By supplementing robust clinical evidence program with more than 35,000 participants in the U.S. for PATHFINDER 2 and over 140,000 participants in England for NHS-Galleri, the company will continue generation of additional performance, safety, and clinical utility data," said Bob Ragusa, Chief Executive Officer at GRAIL. "Both studies were designed to enroll a diverse participant population, representative of socio-economic, ethnicity, gender and age differences, and the company is proud of the diversity of the study populations. The data from these studies, as well as supplemental data from other clinical studies, will support premarket approval application submission for Galleri to the FDA, which is currently in process with a modular submission under a Breakthrough Device Designation from the FDA. The company looks forward to seeing results from the first 25,000 individuals enrolled in the PATHFINDER 2 study in the second half of 2025 and final results from the NHS-Galleri trial in 2026.
Board Change • Jun 27No independent directorsThere is 1 new director who has joined the board in the last 3 years. The new board member was not an independent director. The company's board is composed of: 1 new director. 9 experienced directors. 2 highly experienced directors. No independent directors (11 non-independent directors). Director Chuck Dadswell was the last director to join the board, commencing their role in 2024. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Insufficient board refreshment.
