GRAIL（GRAL）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GRAL 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23.91%増加すると予測されています 過去5年間の収益は年間20.5%増加しました。 リスク分析今後3年間の収益は年平均6.7%減少すると予測されている。 過去1年間で株主の希薄化が進んだ 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 すべてのリスクチェックを見るGRAL Community Fair Values Create NarrativeSee what 27 others think this stock is worth. Follow their fair value or set your own to get alerts.Analyst Price TargetsAN2.8% overvaluedAnalystConsensusTarget•1mo agoGRAL: Execution Risks Remain High Amid PATHFINDER 2 Progress And Regulatory Shifts1.1k018AN22.9% undervaluedAnalystHighTarget•27d agoNHS Trial Momentum And Medicare Pathway Will Support Long Term Multi Cancer Screening Adoption5601AN21.2% overvaluedAnalystLowTarget•13d agoClinical Trial Setbacks And Reimbursement Delays Will Eventually Support Early Cancer Detection Potential2300Top Analyst NarrativesAN2.8% overvaluedAnalystConsensusTarget•1mo agoGRAL: Execution Risks Remain High Amid PATHFINDER 2 Progress And Regulatory Shifts1.1k018AN22.9% undervaluedAnalystHighTarget•27d agoNHS Trial Momentum And Medicare Pathway Will Support Long Term Multi Cancer Screening Adoption5601AN21.2% overvaluedAnalystLowTarget•13d agoClinical Trial Setbacks And Reimbursement Delays Will Eventually Support Early Cancer Detection Potential2300View all narrativesGRAIL, Inc. 競合他社Iovance BiotherapeuticsSymbol: NasdaqGM:IOVAMarket cap: US$3.2bZai LabSymbol: NasdaqGM:ZLABMarket cap: US$2.9bArcutis BiotherapeuticsSymbol: NasdaqGS:ARQTMarket cap: US$3.3bVeracyteSymbol: NasdaqGM:VCYTMarket cap: US$3.3b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$67.8752週高値US$118.8452週安値US$29.95ベータ3.251ヶ月の変化-6.54%3ヶ月変化11.79%1年変化109.28%3年間の変化n/a5年間の変化n/aIPOからの変化396.85%最新ニュースSeeking Alpha • Aug 12GRAIL: Looking Beyond The NHS-Galleri HeadlineSummary GRAIL faces a binary FDA approval event for Galleri, with significant stock movement expected based on the outcome. Despite disappointing NHS-Galleri trial results, I believe the true value of the test would have been apparent with a longer monitoring period. While GRAL has a solid cash position, commercialization delays could see the company having to raise a large amount of capital on unfavorable terms. GRAL's valuation remains modest relative to peers and the size of the MCED opportunity, meaning positive news from the AdCom in September could see the stock move significantly higher. Read the full article on Seeking AlphaPrice Target Changed • Aug 11Price target increased by 9.7% to US$72.38Up from US$66.00, the current price target is an average from 8 analysts. New target price is approximately in line with last closing price of US$75.48. Stock is up 125% over the past year. The company is forecast to post a net loss per share of US$10.03 next year compared to a net loss per share of US$11.11 last year.お知らせ • Aug 09GRAIL Announces FDA Advisory Committee Meeting To Review Premarket Approval Application For The Galleri Multi-Cancer Early Detection TestGRAIL announced that the U.S. Food and Drug Administration's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to meet on September 23, 2026 to review the Premarket Approval application for the Galleri multi-cancer early detection blood test. The Galleri test is designed to detect cancer-specific methylation patterns shared by many types of cancer before symptoms appear, including cancers that do not have recommended screening. When a cancer signal is detected, Galleri is designed to predict the cancer signal origin with high accuracy to help guide diagnostic evaluation. The test is intended to be used in addition to, and not as a replacement for, guideline-recommended screenings. The Galleri technology is unique in how it is designed to examine the methylome using proprietary technology and artificial intelligence. Extensive data has been generated in multiple studies to evaluate the impact of adding Galleri to standard of care screening with positive results showing evidence of increases in screen detected cancers, a low false positive rate and high signal origin prediction accuracy. Galleri is the only MCED test supported by large interventional and randomized, controlled studies in intended use populations. GRAIL submitted its PMA application for Galleri to the FDA on January 29, 2026. The FDA designated Galleri as a Breakthrough Device in 2018. The PMA submission is focused on the test performance and safety results from 25,490 consented participants with one year of follow up in the US-based PATHFINDER 2 study as well as data from over 70,000 participants from the intervention arm of the prevalent screening round (first year) of the NHS-Galleri trial, the largest and only randomized, controlled trial of an MCED test in an intended use population. The submission is also supported by an 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.ライブニュース • Aug 09FDA Panel to Review GRAIL’s Galleri Multi-Cancer Test Application This SeptemberGRAIL said the FDA’s Molecular and Clinical Genetics Panel will meet on 23 September 2026 to review the Premarket Approval application for its Galleri multi-cancer early detection blood test, which has held Breakthrough Device designation since 2018. The Galleri test is designed to identify cancer-specific methylation patterns before symptoms appear and indicate the likely tissue of origin to guide further diagnostic workups. This advisory committee review is a key regulatory step for one of GRAIL’s flagship products. GRAIL’s stock recently traded at $69.48, with the share price down 21.8% year to date, putting extra focus on regulatory milestones such as the upcoming FDA panel meeting. This FDA panel date provides a clear timeline for the next major regulatory risk event, since the committee’s discussion and voting outcomes often frame expectations for any subsequent FDA decision on a device like Galleri.Reported Earnings • Aug 06Second quarter 2026 earnings: EPS and revenues exceed analyst expectationsSecond quarter 2026 results: US$2.56 loss per share (improved from US$3.19 loss in 2Q 2025). Revenue: US$44.7m (up 26% from 2Q 2025). Net loss: US$110.2m (loss narrowed 3.3% from 2Q 2025). Revenue exceeded analyst estimates by 5.4%. Earnings per share (EPS) also surpassed analyst estimates by 3.6%. Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 23% growth forecast for the Biotechs industry in the US.ナラティブ更新 • Aug 03GRAL: Regulatory And Lawsuit Overhang Will Drive Future Downside RiskGRAIL's analyst price target has shifted modestly in recent weeks, with research citing large addressable markets, strong volume trends, better pricing, and ongoing payor and regulatory uncertainty that keeps some firms on the sidelines while others lift targets into the $60 to $88 range. Analyst Commentary Recent Street research on GRAIL highlights a split view.最新情報をもっと見るRecent updatesSeeking Alpha • Aug 12GRAIL: Looking Beyond The NHS-Galleri HeadlineSummary GRAIL faces a binary FDA approval event for Galleri, with significant stock movement expected based on the outcome. Despite disappointing NHS-Galleri trial results, I believe the true value of the test would have been apparent with a longer monitoring period. While GRAL has a solid cash position, commercialization delays could see the company having to raise a large amount of capital on unfavorable terms. GRAL's valuation remains modest relative to peers and the size of the MCED opportunity, meaning positive news from the AdCom in September could see the stock move significantly higher. Read the full article on Seeking AlphaPrice Target Changed • Aug 11Price target increased by 9.7% to US$72.38Up from US$66.00, the current price target is an average from 8 analysts. New target price is approximately in line with last closing price of US$75.48. Stock is up 125% over the past year. The company is forecast to post a net loss per share of US$10.03 next year compared to a net loss per share of US$11.11 last year.お知らせ • Aug 09GRAIL Announces FDA Advisory Committee Meeting To Review Premarket Approval Application For The Galleri Multi-Cancer Early Detection TestGRAIL announced that the U.S. Food and Drug Administration's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to meet on September 23, 2026 to review the Premarket Approval application for the Galleri multi-cancer early detection blood test. The Galleri test is designed to detect cancer-specific methylation patterns shared by many types of cancer before symptoms appear, including cancers that do not have recommended screening. When a cancer signal is detected, Galleri is designed to predict the cancer signal origin with high accuracy to help guide diagnostic evaluation. The test is intended to be used in addition to, and not as a replacement for, guideline-recommended screenings. The Galleri technology is unique in how it is designed to examine the methylome using proprietary technology and artificial intelligence. Extensive data has been generated in multiple studies to evaluate the impact of adding Galleri to standard of care screening with positive results showing evidence of increases in screen detected cancers, a low false positive rate and high signal origin prediction accuracy. Galleri is the only MCED test supported by large interventional and randomized, controlled studies in intended use populations. GRAIL submitted its PMA application for Galleri to the FDA on January 29, 2026. The FDA designated Galleri as a Breakthrough Device in 2018. The PMA submission is focused on the test performance and safety results from 25,490 consented participants with one year of follow up in the US-based PATHFINDER 2 study as well as data from over 70,000 participants from the intervention arm of the prevalent screening round (first year) of the NHS-Galleri trial, the largest and only randomized, controlled trial of an MCED test in an intended use population. The submission is also supported by an 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.ライブニュース • Aug 09FDA Panel to Review GRAIL’s Galleri Multi-Cancer Test Application This SeptemberGRAIL said the FDA’s Molecular and Clinical Genetics Panel will meet on 23 September 2026 to review the Premarket Approval application for its Galleri multi-cancer early detection blood test, which has held Breakthrough Device designation since 2018. The Galleri test is designed to identify cancer-specific methylation patterns before symptoms appear and indicate the likely tissue of origin to guide further diagnostic workups. This advisory committee review is a key regulatory step for one of GRAIL’s flagship products. GRAIL’s stock recently traded at $69.48, with the share price down 21.8% year to date, putting extra focus on regulatory milestones such as the upcoming FDA panel meeting. This FDA panel date provides a clear timeline for the next major regulatory risk event, since the committee’s discussion and voting outcomes often frame expectations for any subsequent FDA decision on a device like Galleri.Reported Earnings • Aug 06Second quarter 2026 earnings: EPS and revenues exceed analyst expectationsSecond quarter 2026 results: US$2.56 loss per share (improved from US$3.19 loss in 2Q 2025). Revenue: US$44.7m (up 26% from 2Q 2025). Net loss: US$110.2m (loss narrowed 3.3% from 2Q 2025). Revenue exceeded analyst estimates by 5.4%. Earnings per share (EPS) also surpassed analyst estimates by 3.6%. Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 23% growth forecast for the Biotechs industry in the US.ナラティブ更新 • Aug 03GRAL: Regulatory And Lawsuit Overhang Will Drive Future Downside RiskGRAIL's analyst price target has shifted modestly in recent weeks, with research citing large addressable markets, strong volume trends, better pricing, and ongoing payor and regulatory uncertainty that keeps some firms on the sidelines while others lift targets into the $60 to $88 range. Analyst Commentary Recent Street research on GRAIL highlights a split view.お知らせ • Jul 30GRAIL, Inc. to Report Q2, 2026 Results on Aug 05, 2026GRAIL, Inc. announced that they will report Q2, 2026 results After-Market on Aug 05, 2026ナラティブ更新 • Jul 20GRAL: Future Reimbursement Progress Will Drive Confidence Despite Trial And Legal HeadwindsGRAIL's analyst price target has shifted from $80 to $88, with analysts citing large addressable markets, strong volume trends, and improving pricing, while still acknowledging a more challenging near-term risk and reward setup and a mixed sector backdrop. Analyst Commentary Recent Street research on Grail reflects a mix of optimism around the company’s testing portfolio and caution around sector and reimbursement risks.ライブニュース • Jul 17GRAIL Expands Galleri Cancer Test Access With Priority Health Employer Coverage In MichiganGRAIL announced a collaboration with Priority Health to offer its Galleri multi-cancer early detection blood test to Priority Health’s self-insured employer groups, extending prior availability beyond Medicare Advantage plans and making Priority Health the first Michigan health plan to cover Galleri for employer groups. The expansion into employer health plans widens potential access to Galleri, giving GRAIL another channel to reach commercially insured patients through workplace benefits rather than relying only on Medicare Advantage coverage. GRAIL’s stock last traded at US$71.96, with the share price up 39.2% over the past 90 days, while the news reflects further commercial traction for its Galleri testing offering. The key takeaway is that broader employer coverage could support wider use of GRAIL’s test, while also introducing execution risks related to employer uptake, clinical integration, and long-term reimbursement support.ナラティブ更新 • Jul 06GRAL: Future Reimbursement Progress Will Drive Confidence After Trial SetbackThe updated analyst price target for GRAIL has shifted from $130 to $80, reflecting a more cautious stance from analysts who highlight regulatory uncertainty around multi cancer early detection tests and the need for clearer reimbursement support before the story can fully play out. Analyst Commentary Recent Street research on Grail has centered on how quickly the company can broaden use of its Galleri multi cancer early detection test beyond the self pay market and into reimbursed channels.ライブニュース • Jul 01GRAIL Faces Securities Fraud Suit After Cancer Trial Disclosures QuestionedGRAIL, Inc. and certain senior executives are facing a securities fraud class action in the U.S. District Court for the Northern District of California, alleging they misrepresented the design and results of the NHS-Galleri cancer detection trial and its failure to meet the primary endpoint of reducing late-stage cancers, following a stock price decline of more than 50%. The complaint also claims GRAIL did not disclose concerns that the trial duration might be too short to show the intended endpoint, and investors who believe they were harmed have until August 4, 2026, to seek to join the lawsuit. GRAIL’s stock last traded at US$68.27, with the share price down 23.2% year to date, which illustrates how legal and disclosure risks can feed directly into valuation pressure and raise the bar for investor confidence in clinical data.お知らせ • Jun 26GRAIL, Inc. announced that it has received $110.000075 million in funding from Samsung Electronics Co., Ltd., Samsung Electronics Singapore Pte. Ltd., Samsung C&T CorporationOn June 25, 2026, GRAIL, Inc. closed the transaction.ライブニュース • Jun 22Grail Faces Class Action Over NHS-Galleri Trial Disclosures and Data ConcernsMultiple law firms have launched a securities class action against GRAIL, alleging the company made false and misleading statements about its NHS-Galleri cancer detection trial between May 13, 2025 and February 19, 2026, including claims it concealed adverse internal data and misrepresented the trial’s design and timeframe. The lawsuit follows disclosures that the NHS-Galleri trial did not meet its primary endpoint of reducing late-stage (Stage III–IV) cancers, after which GRAIL’s stock reportedly fell about 50% in one session, creating substantial claimed losses for shareholders in the defined class period. GRAIL shares most recently traded at $63.74, with the stock down 28.3% year to date, indicating a period of pressure as the company faces both clinical questions and securities litigation risk. This type of suit can be lengthy and costly, and it adds an extra layer of uncertainty on top of trial outcomes that are central to GRAIL’s business model.ナラティブ更新 • Jun 22GRAL: Future Returns Will Hinge On Trial Outcomes And Reimbursement ClarityThe GRAIL analyst price target has been modestly reset, slipping from $66.86 to $66.00 as analysts factor in a slightly higher discount rate and ongoing uncertainty around regulatory review and payor reimbursement for the Galleri test. Analyst Commentary Recent Street research on GRAIL points to a cautious but engaged stance, with Goldman Sachs and several other firms sitting at the middle of the spectrum as they weigh the commercial opportunity for the Galleri test against open questions on regulation and reimbursement.分析記事 • Jun 20GRAIL (GRAL) Stock Could Be 4.7% Undervalued After NHS Galleri Trial SetbackGRAIL (GRAL) is under pressure after disclosing that its NHS Galleri trial did not achieve the expected statistically significant reduction in late stage cancers, triggering multiple securities class action lawsuits and sharp investor concern. See our latest analysis for GRAIL. The failed NHS Galleri trial and subsequent lawsuits came after a sharp one day drop earlier in the year. Since then, the stock has shown mixed momentum, with a 90 day share price return of 36.08%, a year to date share...ライブニュース • Jun 10Grail Faces Investor Lawsuits Over Alleged Misleading Cancer Trial DisclosuresMultiple law firms have filed securities class action lawsuits against Grail, Inc. on behalf of investors who bought GRAL between May 13, 2025 and February 19, 2026. The suits allege Grail made false and misleading statements about the effectiveness and primary endpoint results of its NHS-Galleri cancer screening trial. Investors are being encouraged to seek compensation and to consider moving for lead plaintiff status, with an August 4, 2026 deadline to participate. The key issue is whether Grail’s disclosures around the NHS-Galleri trial results were sufficiently accurate and complete, which now sits at the center of this litigation. Investors considering GRAL or already holding it may want to track legal updates and company communications closely, since class action outcomes can affect legal costs, management focus and market perception.ナラティブ更新 • Jun 04GRAL: Future Returns Will Reflect Trial Evidence And Reimbursement ProgressGRAIL's analyst price target has been reduced by about $1 per share as analysts factor in more balanced assumptions on reimbursement progress, profitability, and long-term P/E expectations, following a mix of cautious initiations and price target changes across the Street. Analyst Commentary Recent Street research on GRAIL points to a more balanced stance, with a mix of cautious initiations, price target reductions, and a smaller number of positive adjustments that keep expectations in check.お知らせ • Jun 02+ 1 more updateGRAIL, Inc. Reports Full Results From NHS-Galleri Trial Demonstrating Substantial Reduction In Stage IV Cancer DiagnosesGRAIL, Inc. announced detailed clinical utility, performance and safety results from its landmark NHS-Galleri trial in an oral presentation at the 2026 American Society of Clinical Oncology Annual Meeting. The NHS-Galleri trial is the first and only randomized, controlled trial of a multi-cancer early detection (MCED) test and evaluated annual screening with the Galleri test in England's National Health Service (NHS) over three years in 142,250 demographically representative participants aged 50 to 77 at enrollment. The NHS-Galleri trial evaluated a combined primary endpoint of Stage III and IV diagnoses in a pre-specified group of 12 deadly cancers when the Galleri test was added to standard of care screening in England (breast, bowel, cervical and high risk lung cancers) versus standard of care screening alone; however, there was no statistically significant difference within a 1-year follow up window after the last appointment. Follow-up will continue, with further results published as available. One of the aims of screening is to reduce the incidence of metastatic late stage cancer. In the Galleri arm, Stage IV cancer diagnoses decreased with each year of sequential screening, with a 9% reduction in the first screening round, a 22% reduction in the second round, and a 26% reduction in the third round in the pre-specified group of 12 cancers. The prevalent round detects undiagnosed cancers already present in the population at the time of initial screening, while subsequent incident rounds detect cancers that develop or progress between screening rounds and become detectable. Thus, the incident rounds most closely approximate the likely steady-state impact of an annual screening program. Overall, in this pre-specified secondary endpoint, a 14% reduction in Stage IV cancers was observed. These results were nominally statistically significant. Similar reductions of 20% or more were observed in the second and third screening rounds for all stageable cancers. Within the overall trend of Stage IV reduction, in an exploratory analysis, meaningful reductions in Stage IV diagnoses were observed in cancer types where 5-year survival is substantially higher when diagnosed at Stage III versus IV. For example, Stage IV diagnoses were reduced by 57.1% in esophageal cancer and 34.4% in colorectal cancer in the incident rounds. The five-year survival rates in England are significantly higher in Stage III than Stage IV for each of these cancers: 24.7% vs 6.2% for esophageal cancer, 64.2% vs 11.0% for colorectal cancer. Relative Incidence Rate of Combined Stage III/IV Cancers Decreased After the First Round of Screening in the Pre-Specified Group of 12 Cancers; Relative Incidence Rate of Stage IV Cancers Decreased Each Screening Round. Stage III/IV Cancers Diagnosed Incidence Rate Ratio Intervention vs Control (% Difference): After 3 Screening Rounds 1.03 (0.92, 1.14) ?3%, p=0.6324; First Screening Round (Prevalent) 1.19 (0.98, 1.43) ?19%; Second Screening Round (Incident) 0.95 (0.77, 1.17) ?5%; Third Screening Round (Incident) 0.88 (0.73, 1.07) ?12%. Stage IV Cancers Diagnosed Incidence Rate Ratio Intervention vs Control (% Difference): After 3 Screening Rounds 0.86 (0.744, 0.998) ?14%; First Screening Round (Prevalent) 0.91 (0.71, 1.18) ?9%; Second Screening Round (Incident) 0.78 (0.57, 1.06) ?22%; Third Screening Round (Incident) 0.74 (0.57, 0.95) ?26%. Along with the decrease in Stage IV cancer incidence, Stage I and II cancers diagnosed increased by 16% for the 12 prespecified cancer types after three rounds of screening, including large increases in many types typically diagnosed late, such as ovarian, esophageal, pancreatic and liver cancers. The addition of the Galleri test to standard-of-care cancer screenings led to a four-fold increase in screen-detected cancers and a 21% decrease in the number of clinically detected cancers after symptomatic presentation. Further, the addition of MCED screening was associated with cancers diagnosed after emergency presentation decreasing by 25%. 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. Over three screening rounds, 1,801 participants (0.91%) had a positive MCED test result and 937 were diagnosed with cancer, for a cancer detection rate of 0.48%. PPV was 52.0% overall and 58.0% in the first screening round. Specificity was 99.55%, resulting in a low false positive rate of 0.45%. CSO accuracy was 92.5%. Episode sensitivity – the ability to detect cancers that were diagnosed within 12 months after each Galleri screening blood draw - was 54.7% for the 12 prespecified cancer types and 30.7% across all cancer types. There were no serious related adverse events reported in the trial, reaffirming the safety profile of the test. The results of the NHS-Galleri trial will be submitted for publication in a peer-reviewed medical journal.分析記事 • May 08Here's What Analysts Are Forecasting For GRAIL, Inc. (NASDAQ:GRAL) After Its First-Quarter ResultsA week ago, GRAIL, Inc. ( NASDAQ:GRAL ) came out with a strong set of first-quarter numbers that could potentially lead...ナラティブ更新 • May 07GRAL: Future Returns Will Reflect Trial Outcomes And Reimbursement ProgressNarrative Update on GRAIL Analysts have trimmed their average price target for GRAIL by incorporating lower profit margin assumptions and a slightly higher future P/E of about 101x, following mixed reactions to recent study readouts and reimbursement uncertainty. Analyst Commentary Recent research updates on GRAIL reflect a split tape, with some firms trimming price targets after the NHS Galleri readout and reimbursement uncertainty, while others still see room for upside based on the company’s test portfolio and addressable market.Reported Earnings • May 06First quarter 2026 earnings: EPS and revenues exceed analyst expectationsFirst quarter 2026 results: US$2.29 loss per share (improved from US$3.10 loss in 1Q 2025). Revenue: US$40.8m (up 28% from 1Q 2025). Net loss: US$93.2m (loss narrowed 12% from 1Q 2025). Revenue exceeded analyst estimates by 4.2%. Earnings per share (EPS) also surpassed analyst estimates by 17%. Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US.お知らせ • Apr 30GRAIL, Inc., Annual General Meeting, Jun 18, 2026GRAIL, Inc., Annual General Meeting, Jun 18, 2026.Board Change • Apr 29High number of new and inexperienced directorsThere are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. No experienced directors. No highly experienced directors. Independent Director Bill Chase is the most experienced director on 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 board continuity. Lack of experienced directors.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ナラティブ更新 • Apr 19GRAL: Future Returns Will Depend On Upcoming FDA Approval DecisionAnalysts have trimmed GRAIL's average price target to about $67.71 from $72.40. They cited updated models that factor in recent price target cuts following the NHS-Galleri topline readout and lingering uncertainty around broad reimbursement, even as revenue growth and margin assumptions are slightly adjusted.Recent Insider Transactions • Apr 17CEO & Director recently sold US$6.2m worth of stockOn the 8th of April, Robert Ragusa sold around 124k shares on-market at roughly US$49.92 per share. This transaction amounted to 29% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Robert has been a net seller over the last 12 months, reducing personal holdings by US$15m.Recent Insider Transactions Derivative • Apr 08CEO & Director notifies of intention to sell stockRobert Ragusa intends to sell 133k shares in the next 90 days after lodging an Intent To Sell Form on the 6th of April. If the sale is conducted around the recent share price of US$51.74, it would amount to US$6.9m. For the year to December 2022, Robert's total compensation was 10% salary and 90% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since June 2025, Robert's direct individual holding has increased from 205.85k shares to 218.25k. Company insiders have collectively sold US$23m more than they bought, via options and on-market transactions in the last 12 months.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.ナラティブ更新 • Apr 05GRAL: Future Returns Will Hinge On Upcoming Regulatory And Coverage MilestonesNarrative Update on GRAIL The analyst price target for GRAIL has been reduced by $11.00. This change reflects recent cuts across firms citing the NHS Galleri study missing its primary endpoint and greater uncertainty around broad reimbursement, even as analysts still reference GRAIL's position in multi cancer early detection and upcoming regulatory and coverage milestones.Price Target Changed • Mar 29Price target decreased by 18% to US$72.40Down from US$88.00, the current price target is an average from 5 analysts. New target price is 49% above last closing price of US$48.49. Stock is up 80% over the past year. The company is forecast to post a net loss per share of US$11.02 next year compared to a net loss per share of US$11.11 last year.ナラティブ更新 • Mar 21GRAL: Future Returns Will Depend On NHS Study OutcomeNarrative Update: GRAIL Analyst Price Target Shift The updated analyst fair value estimate for GRAIL has moved from $88.00 to $83.40 as analysts factor in lower published price targets following the NHS Galleri study missing its primary endpoint and increased uncertainty around broad reimbursement, while still modeling higher revenue, stronger profit margins, and a lower future P/E multiple. Analyst Commentary Recent Street research shows a mix of optimism and caution around GRAIL, with several firms revising price targets after the NHS Galleri study update and recent quarterly results.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.Recent Insider Transactions • Mar 11CEO & Director recently sold US$409k worth of stockOn the 9th of March, Robert Ragusa sold around 8k shares on-market at roughly US$48.48 per share. This transaction amounted to 1.3% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Robert has been a net seller over the last 12 months, reducing personal holdings by US$7.4m.新しいナラティブ • Mar 08Clinical Trial Setbacks And Reimbursement Delays Will Eventually Support Early Cancer Detection PotentialCatalysts About GRAIL GRAIL focuses on multi cancer early detection through its Galleri screening test and related clinical programs. What are the underlying business or industry changes driving this perspective?ナラティブ更新 • Mar 06GRAL: Future Returns Will Hinge On NHS Study And FDA DecisionThe analyst fair value estimate for Grail has been trimmed from $114.50 to $88.00 as analysts factor in lower revenue growth and profit margin assumptions following the NHS Galleri readout and increased uncertainty around broad reimbursement. Analyst Commentary Street research on Grail has shifted meaningfully following the NHS Galleri top line readout, with several firms reducing price targets and reassessing the risk and reward profile around Galleri adoption and reimbursement.Recent Insider Transactions Derivative • Mar 03CEO & Director notifies of intention to sell stockRobert Ragusa intends to sell 41k shares in the next 90 days after lodging an Intent To Sell Form on the 2nd of March. If the sale is conducted around the recent share price of US$53.23, it would amount to US$2.2m. For the year to December 2022, Robert's total compensation was 10% salary and 90% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2025, Robert's direct individual holding has increased from 127.65k shares to 173.43k. Company insiders have collectively sold US$20m more than they bought, via options and on-market transactions in the last 12 months.新しいナラティブ • Feb 22NHS Trial Momentum And Medicare Pathway Will Support Long Term Multi Cancer Screening AdoptionCatalysts About GRAIL GRAIL develops and commercializes Galleri, a blood based multi cancer early detection test aimed at finding cancers at earlier stages. What are the underlying business or industry changes driving this perspective?Price Target Changed • Feb 22Price target decreased by 13% to US$101Down from US$115, the current price target is an average from 4 analysts. New target price is 100% above last closing price of US$50.21. Stock is up 23% over the past year. The company is forecast to post a net loss per share of US$10.95 next year compared to a net loss per share of US$11.11 last year.New Risk • Feb 21New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 12% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings are forecast to decline by an average of 3.7% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$539m net loss in 3 years). Shareholders have been diluted in the past year (19% increase in shares outstanding). Significant insider selling over the past 3 months (US$7.6m sold).Reported Earnings • Feb 20Full year 2025 earnings: EPS exceeds analyst expectationsFull 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 was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 2.6%. Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US.ナラティブ更新 • Feb 20GRAL: Future Returns Will Hinge On Upcoming NHS Trial ReadoutThe average analyst price target for Grail has edged down by $0.50 to about $114.50, as analysts balance optimism around upcoming trial readouts and potential regulatory milestones with a more cautious stance after the stock's very large move earlier in 2025 and ongoing execution risks. Analyst Commentary Recent research on Grail reflects a mix of enthusiasm for its position in multi cancer early detection and caution around valuation and execution timelines.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ナラティブ更新 • Feb 04GRAL: Future Returns Will Depend On NHS Readout And Execution ConsistencyNarrative Update Analysts have lifted their price target on GRAIL from $105 to $115, citing refreshed models that reflect updated assumptions for growth, margins and future P/E. Recent research highlights steady execution, the long term Galleri opportunity, and the absence of thesis changing developments in recent results.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.ナラティブ更新 • Jan 20GRAL: Future Returns Will Hinge On NHS Trial And Execution RisksAnalysts have nudged their price target on GRAIL up to $110 from $85, citing steady execution, a modest Q4 revenue beat, and the longer term opportunity for the Galleri test, despite the inherent risks that come with new technologies. Analyst Commentary Analysts see GRAIL's recent results as an incremental step rather than a major reset, with views split between confidence in execution and caution around key milestones like the NHS Galleri trial readout.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.ナラティブ更新 • Jan 06GRAL: Long Term MCED Opportunity And Execution Risks Will Shape Future ReturnsAnalysts have raised their price target range for GRAIL to about $85 from around $38, citing updated post-Q3 estimates and what they view as a significant long-term commercial opportunity for the Galleri multi-cancer early detection test, while also highlighting the risks associated with this type of novel technology. Analyst Commentary Bullish Takeaways Bullish analysts see the increase in the price target range to about $85 as a reflection of what they view as a sizeable commercial runway for the Galleri multi cancer early detection test over the long term.ナラティブ更新 • Dec 16GRAL: Future MCED Policy Shifts Will Drive Upside Despite Execution RisksAnalysts have raised their price target on GRAIL to $105 from $96.67, citing updated post earnings estimates and growing confidence in the long term commercial potential of the Galleri multi cancer early detection platform, despite ongoing technology and regulatory risks. Analyst Commentary Recent Street research reflects a meaningful reset in expectations for GRAIL, with multiple price target increases grounded in updated post earnings models and a clearer view of Galleri's commercial runway.Recent Insider Transactions • Dec 07CEO & Director recently sold US$3.8m worth of stockOn the 3rd of December, Robert Ragusa sold around 40k shares on-market at roughly US$95.24 per share. This transaction amounted to 19% 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 US$5.1m. Robert has been a net seller over the last 12 months, reducing personal holdings by US$7.8m.Recent Insider Transactions Derivative • Dec 04Chief Financial Officer notifies of intention to sell stockAaron Freidin intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 3rd of December. If the sale is conducted around the recent share price of US$99.15, it would amount to US$2.5m. Since March 2025, Aaron's direct individual holding has increased from 45.05k shares to 78.95k. Company insiders have collectively sold US$13m more than they bought, via options and on-market transactions in the last 12 months.ナラティブ更新 • Dec 01GRAL: Risks From Clinical Data and Execution Will Remain a Key ConcernAnalysts have raised their price target for GRAIL from approximately $90 to $97 per share, citing strengthened confidence in the company’s long-term growth prospects. This outlook is driven by recent developments and opportunities in multi-cancer early detection.ナラティブ更新 • Nov 17GRAL: Confidence Will Increase With Upcoming Clinical Data and Legislative ProgressAnalysts have raised their price target for GRAIL from $61.50 to $90.00. This change reflects increased confidence in the company’s long-term prospects and growth potential, following recent updates and a positive outlook on its multi-cancer early detection technology.New Risk • Nov 14New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 16% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 3.8% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$538m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (16% increase in shares outstanding). Significant insider selling over the past 3 months (US$5.7m sold).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: EPS and revenues exceed analyst expectationsThird 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 exceeded analyst estimates by 2.2%. Earnings per share (EPS) also surpassed analyst estimates by 29%. Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US.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.ナラティブ更新 • Nov 01GRAL: Execution Risks Remain High Amid PATHFINDER 2 Progress And Regulatory ShiftsAnalysts have raised GRAIL's fair value estimate from $56.50 to $61.50 per share, citing greater confidence in the company's platforms, ongoing clinical milestones, and evolving market opportunities as key drivers for the upward revision. Analyst Commentary Bullish Takeaways Bullish analysts highlight growing confidence in GRAIL's platforms.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.ナラティブ更新 • Oct 18FDA Approval And NHS Studies Will Transform Cancer DetectionAnalysts have raised their price target on GRAIL significantly, from $43 to $75. They cite growing confidence in the company's platforms, anticipated improvements in test performance, and the potential impact of future legislative changes as reasons for this adjustment.Recent Insider Transactions • Oct 18CEO & Director recently sold US$499k worth of stockOn the 15th of October, Robert Ragusa sold around 7k shares on-market at roughly US$68.88 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 US$5.1m. Robert has been a net seller over the last 12 months, reducing personal holdings by US$4.0m.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 Derivative • Oct 16President notifies of intention to sell stockJoshua Ofman intends to sell 15k shares in the next 90 days after lodging an Intent To Sell Form on the 15th of October. If the sale is conducted around the recent share price of US$69.29, it would amount to US$1.0m. Since March 2025, Joshua's direct individual holding has increased from 76.44k shares to 166.72k. Company insiders have collectively sold US$12m more than they bought, via options and on-market transactions in the last 12 months.Recent Insider Transactions • Oct 10President recently sold US$5.1m worth of stockOn the 6th of October, Joshua Ofman sold around 81k shares on-market at roughly US$62.50 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 US$6.9m.ナラティブ更新 • Oct 04FDA Approval And NHS Studies Will Transform Cancer DetectionAnalysts have raised their price target for GRAIL from $40.50 to $56.50. They cite strengthened confidence in the company's platforms, positive expectations for future study results, and anticipation of supportive legislative developments.Recent Insider Transactions Derivative • Oct 03President notifies of intention to sell stockJoshua Ofman intends to sell 10k shares in the next 90 days after lodging an Intent To Sell Form on the 2nd of October. If the sale is conducted around the recent share price of US$62.06, it would amount to US$601k. Since December 2024, Joshua's direct individual holding has increased from 72.25k shares to 104.99k. Company insiders have collectively sold US$9.0m more than they bought, via options and on-market transactions in the last 12 months.New Risk • Sep 29New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 0.2% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$501m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (16% increase in shares outstanding).Reported Earnings • Aug 13Second quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behindSecond 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 missed analyst estimates by 3.7%. Earnings per share (EPS) exceeded analyst estimates by 13%. Revenue is forecast to grow 19% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US.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, 2025Recent Insider Transactions Derivative • Jul 16Chief Financial Officer notifies of intention to sell stockAaron Freidin intends to sell 8k shares in the next 90 days after lodging an Intent To Sell Form on the 15th of July. If the sale is conducted around the recent share price of US$40.18, it would amount to US$321k. Since September 2024, Aaron's direct individual holding has increased from 15.01k shares to 83.87k. Company insiders have collectively sold US$10m more than they bought, via options and on-market transactions in the last 12 months.Recent Insider Transactions Derivative • Jul 01President notifies of intention to sell stockJoshua Ofman intends to sell 10k shares in the next 90 days after lodging an Intent To Sell Form on the 30th of June. If the sale is conducted around the recent share price of US$48.39, it would amount to US$469k. Since September 2024, Joshua's direct individual holding has increased from 72.25k shares to 110.81k. Company insiders have collectively sold US$10m more than they bought, via options and on-market transactions in the last 12 months.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.新しいナラティブ • Jun 15Overvaluation Risks And NHS Trials Will Spur Future Resilience Market optimism may overestimate Galleri's near-term adoption and pricing power due to regulatory, payer, and competitive pressures. Recent Insider Transactions Derivative • Jun 13President notifies of intention to sell stockJoshua Ofman intends to sell 10k shares in the next 90 days after lodging an Intent To Sell Form on the 12th of June. If the sale is conducted around the recent share price of US$43.87, it would amount to US$425k. Since June 2024, Joshua's direct individual holding has increased from 7.93k shares to 120.50k. Company insiders have collectively sold US$10m more than they bought, via options and on-market transactions in the last 12 months.Reported Earnings • May 14First quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behindFirst quarter 2025 results: US$3.10 loss per share. Revenue: US$31.8m (up 19% from 1Q 2024). Net loss: US$106.2m (loss narrowed 52% from 1Q 2024). Revenue missed analyst estimates by 9.6%. Earnings per share (EPS) exceeded analyst estimates by 22%. Revenue is forecast to grow 18% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US.Recent Insider Transactions • May 08CEO & Director recently sold US$3.2m worth of stockOn the 2nd of May, Robert Ragusa sold around 94k shares on-market at roughly US$33.93 per share. This transaction amounted to 31% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Robert has been a net seller over the last 12 months, reducing personal holdings by US$5.2m.Recent Insider Transactions Derivative • May 01CEO & Director notifies of intention to sell stockRobert Ragusa intends to sell 96k shares in the next 90 days after lodging an Intent To Sell Form on the 1st of May. If the sale is conducted around the recent share price of US$36.81, it would amount to US$3.5m. For the year to December 2022, Robert's total compensation was 10% salary and 90% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since June 2024, Robert's direct individual holding has increased from 857.00 shares to 127.65k. Company insiders have collectively sold US$4.1m more than they bought, via options and on-market transactions in the last 12 months.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.Recent Insider Transactions • Mar 16CEO & Director recently sold US$238k worth of stockOn the 7th of March, Robert Ragusa sold around 8k shares on-market at roughly US$31.21 per share. This transaction amounted to 6.3% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Robert has been a net seller over the last 12 months, reducing personal holdings by US$2.0m.Reported Earnings • Feb 21Full year 2024 earnings: EPS and revenues exceed analyst expectationsFull 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 exceeded analyst estimates by 2.7%. Earnings per share (EPS) also surpassed analyst estimates by 4.7%. Revenue is forecast to grow 14% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US.New Risk • Feb 13New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 19% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (19% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$608m net loss in 3 years). Significant insider selling over the past 3 months (US$427k sold).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, 2025Seeking Alpha • Jan 22GRAIL: Cash Burn And Commercialization Timeline Are ProblematicSummary GRAIL is a developer of blood-based cancer tests and is initially targeting the multi-cancer early detection market. This market will be large due to the prevalence of cancer, along with the lack of screening options for some cancers and poor compliance rates with current screening methods. GRAIL's flagship product, Galleri, has enormous potential but faces competition and is years away from generating meaningful revenue. Regulatory approval and reimbursement are critical, with key trials ongoing in support of this. Read the full article on Seeking Alpha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.分析記事 • Dec 24Here's Why We're Watching GRAIL's (NASDAQ:GRAL) Cash Burn SituationThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, although Amazon.com...New Risk • Dec 18New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$572m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Significant insider selling over the past 3 months (US$2.2m sold).Seeking Alpha • Dec 16Grail: Lack Of Near Term Catalyst; Market Likely To Lose Interest SoonSummary Grail's net cash balance of $25.71 per share suggests potential undervaluation as it trades at ~$21 per share. However, this cash balance is already part of ongoing expenditure. The risk of failing current NHS trials further complicates the investment outlook. Given these factors, entry at current prices is not favorable. Read the full article on Seeking AlphaRecent Insider Transactions • Nov 21Chief Financial Officer recently sold US$427k worth of stockOn the 18th of November, Aaron Freidin sold around 30k shares on-market at roughly US$14.02 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 US$1.7m. Aaron has been a net seller over the last 12 months, reducing personal holdings by US$681k.株主還元GRALUS BiotechsUS 市場7D-2.3%0.5%0.6%1Y109.3%35.8%20.1%株主還元を見る業界別リターン: GRAL過去 1 年間で35.8 % の収益を上げたUS Biotechs業界を上回りました。リターン対市場: GRAL過去 1 年間で20.1 % の収益を上げたUS市場を上回りました。価格変動Is GRAL's price volatile compared to industry and market?GRAL volatilityGRAL Average Weekly Movement10.8%Biotechs Industry Average Movement9.9%Market Average Movement7.1%10% most volatile stocks in US Market16.3%10% least volatile stocks in US Market3.1%安定した株価: GRAL 、 US市場と比較して、過去 3 か月間で大きな価格変動はありませんでした。時間の経過による変動: GRALの 週次ボラティリティ ( 11% ) は過去 1 年間安定しています。会社概要設立従業員CEO（最高経営責任者ウェブサイト2015910Josh Ofmangrail.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歳以上の無症状の人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、同社のプレシジョン・オンコロジー・ポートフォリオは、疾患予後予測、リスク層別化、最小残存病変検出、再発・再燃モニタリングへの応用を可能にするn RUO標的メチル化ベースのプラットフォームで構成されている。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。GRAL 基礎統計学時価総額US$3.03b収益（TTM）-US$391.59m売上高(TTM)US$165.26m18.3xP/Sレシオ-7.7xPER（株価収益率GRAL 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GRAL 損益計算書（TTM）収益US$165.26m売上原価US$83.12m売上総利益US$82.15mその他の費用US$473.73m収益-US$391.59m直近の収益報告Jun 30, 2026次回決算日該当なし一株当たり利益（EPS）-8.77グロス・マージン49.71%純利益率-236.95%有利子負債／自己資本比率0%GRAL 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2026/08/16 13:28終値2026/08/14 00:00収益2026/06/30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この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、レポートの活用方法に関するガイドやYouTubeのチュートリアルも用意しています。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. 9 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。14 アナリスト機関Catherine Ramsey SchulteBairdRobert BambergerBairdKyle MiksonCanaccord Genuity11 その他のアナリストを表示
Seeking Alpha • Aug 12GRAIL: Looking Beyond The NHS-Galleri HeadlineSummary GRAIL faces a binary FDA approval event for Galleri, with significant stock movement expected based on the outcome. Despite disappointing NHS-Galleri trial results, I believe the true value of the test would have been apparent with a longer monitoring period. While GRAL has a solid cash position, commercialization delays could see the company having to raise a large amount of capital on unfavorable terms. GRAL's valuation remains modest relative to peers and the size of the MCED opportunity, meaning positive news from the AdCom in September could see the stock move significantly higher. Read the full article on Seeking Alpha
Price Target Changed • Aug 11Price target increased by 9.7% to US$72.38Up from US$66.00, the current price target is an average from 8 analysts. New target price is approximately in line with last closing price of US$75.48. Stock is up 125% over the past year. The company is forecast to post a net loss per share of US$10.03 next year compared to a net loss per share of US$11.11 last year.
お知らせ • Aug 09GRAIL Announces FDA Advisory Committee Meeting To Review Premarket Approval Application For The Galleri Multi-Cancer Early Detection TestGRAIL announced that the U.S. Food and Drug Administration's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to meet on September 23, 2026 to review the Premarket Approval application for the Galleri multi-cancer early detection blood test. The Galleri test is designed to detect cancer-specific methylation patterns shared by many types of cancer before symptoms appear, including cancers that do not have recommended screening. When a cancer signal is detected, Galleri is designed to predict the cancer signal origin with high accuracy to help guide diagnostic evaluation. The test is intended to be used in addition to, and not as a replacement for, guideline-recommended screenings. The Galleri technology is unique in how it is designed to examine the methylome using proprietary technology and artificial intelligence. Extensive data has been generated in multiple studies to evaluate the impact of adding Galleri to standard of care screening with positive results showing evidence of increases in screen detected cancers, a low false positive rate and high signal origin prediction accuracy. Galleri is the only MCED test supported by large interventional and randomized, controlled studies in intended use populations. GRAIL submitted its PMA application for Galleri to the FDA on January 29, 2026. The FDA designated Galleri as a Breakthrough Device in 2018. The PMA submission is focused on the test performance and safety results from 25,490 consented participants with one year of follow up in the US-based PATHFINDER 2 study as well as data from over 70,000 participants from the intervention arm of the prevalent screening round (first year) of the NHS-Galleri trial, the largest and only randomized, controlled trial of an MCED test in an intended use population. The submission is also supported by an 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.
ライブニュース • Aug 09FDA Panel to Review GRAIL’s Galleri Multi-Cancer Test Application This SeptemberGRAIL said the FDA’s Molecular and Clinical Genetics Panel will meet on 23 September 2026 to review the Premarket Approval application for its Galleri multi-cancer early detection blood test, which has held Breakthrough Device designation since 2018. The Galleri test is designed to identify cancer-specific methylation patterns before symptoms appear and indicate the likely tissue of origin to guide further diagnostic workups. This advisory committee review is a key regulatory step for one of GRAIL’s flagship products. GRAIL’s stock recently traded at $69.48, with the share price down 21.8% year to date, putting extra focus on regulatory milestones such as the upcoming FDA panel meeting. This FDA panel date provides a clear timeline for the next major regulatory risk event, since the committee’s discussion and voting outcomes often frame expectations for any subsequent FDA decision on a device like Galleri.
Reported Earnings • Aug 06Second quarter 2026 earnings: EPS and revenues exceed analyst expectationsSecond quarter 2026 results: US$2.56 loss per share (improved from US$3.19 loss in 2Q 2025). Revenue: US$44.7m (up 26% from 2Q 2025). Net loss: US$110.2m (loss narrowed 3.3% from 2Q 2025). Revenue exceeded analyst estimates by 5.4%. Earnings per share (EPS) also surpassed analyst estimates by 3.6%. Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 23% growth forecast for the Biotechs industry in the US.
ナラティブ更新 • Aug 03GRAL: Regulatory And Lawsuit Overhang Will Drive Future Downside RiskGRAIL's analyst price target has shifted modestly in recent weeks, with research citing large addressable markets, strong volume trends, better pricing, and ongoing payor and regulatory uncertainty that keeps some firms on the sidelines while others lift targets into the $60 to $88 range. Analyst Commentary Recent Street research on GRAIL highlights a split view.
Seeking Alpha • Aug 12GRAIL: Looking Beyond The NHS-Galleri HeadlineSummary GRAIL faces a binary FDA approval event for Galleri, with significant stock movement expected based on the outcome. Despite disappointing NHS-Galleri trial results, I believe the true value of the test would have been apparent with a longer monitoring period. While GRAL has a solid cash position, commercialization delays could see the company having to raise a large amount of capital on unfavorable terms. GRAL's valuation remains modest relative to peers and the size of the MCED opportunity, meaning positive news from the AdCom in September could see the stock move significantly higher. Read the full article on Seeking Alpha
Price Target Changed • Aug 11Price target increased by 9.7% to US$72.38Up from US$66.00, the current price target is an average from 8 analysts. New target price is approximately in line with last closing price of US$75.48. Stock is up 125% over the past year. The company is forecast to post a net loss per share of US$10.03 next year compared to a net loss per share of US$11.11 last year.
お知らせ • Aug 09GRAIL Announces FDA Advisory Committee Meeting To Review Premarket Approval Application For The Galleri Multi-Cancer Early Detection TestGRAIL announced that the U.S. Food and Drug Administration's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to meet on September 23, 2026 to review the Premarket Approval application for the Galleri multi-cancer early detection blood test. The Galleri test is designed to detect cancer-specific methylation patterns shared by many types of cancer before symptoms appear, including cancers that do not have recommended screening. When a cancer signal is detected, Galleri is designed to predict the cancer signal origin with high accuracy to help guide diagnostic evaluation. The test is intended to be used in addition to, and not as a replacement for, guideline-recommended screenings. The Galleri technology is unique in how it is designed to examine the methylome using proprietary technology and artificial intelligence. Extensive data has been generated in multiple studies to evaluate the impact of adding Galleri to standard of care screening with positive results showing evidence of increases in screen detected cancers, a low false positive rate and high signal origin prediction accuracy. Galleri is the only MCED test supported by large interventional and randomized, controlled studies in intended use populations. GRAIL submitted its PMA application for Galleri to the FDA on January 29, 2026. The FDA designated Galleri as a Breakthrough Device in 2018. The PMA submission is focused on the test performance and safety results from 25,490 consented participants with one year of follow up in the US-based PATHFINDER 2 study as well as data from over 70,000 participants from the intervention arm of the prevalent screening round (first year) of the NHS-Galleri trial, the largest and only randomized, controlled trial of an MCED test in an intended use population. The submission is also supported by an 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.
ライブニュース • Aug 09FDA Panel to Review GRAIL’s Galleri Multi-Cancer Test Application This SeptemberGRAIL said the FDA’s Molecular and Clinical Genetics Panel will meet on 23 September 2026 to review the Premarket Approval application for its Galleri multi-cancer early detection blood test, which has held Breakthrough Device designation since 2018. The Galleri test is designed to identify cancer-specific methylation patterns before symptoms appear and indicate the likely tissue of origin to guide further diagnostic workups. This advisory committee review is a key regulatory step for one of GRAIL’s flagship products. GRAIL’s stock recently traded at $69.48, with the share price down 21.8% year to date, putting extra focus on regulatory milestones such as the upcoming FDA panel meeting. This FDA panel date provides a clear timeline for the next major regulatory risk event, since the committee’s discussion and voting outcomes often frame expectations for any subsequent FDA decision on a device like Galleri.
Reported Earnings • Aug 06Second quarter 2026 earnings: EPS and revenues exceed analyst expectationsSecond quarter 2026 results: US$2.56 loss per share (improved from US$3.19 loss in 2Q 2025). Revenue: US$44.7m (up 26% from 2Q 2025). Net loss: US$110.2m (loss narrowed 3.3% from 2Q 2025). Revenue exceeded analyst estimates by 5.4%. Earnings per share (EPS) also surpassed analyst estimates by 3.6%. Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 23% growth forecast for the Biotechs industry in the US.
ナラティブ更新 • Aug 03GRAL: Regulatory And Lawsuit Overhang Will Drive Future Downside RiskGRAIL's analyst price target has shifted modestly in recent weeks, with research citing large addressable markets, strong volume trends, better pricing, and ongoing payor and regulatory uncertainty that keeps some firms on the sidelines while others lift targets into the $60 to $88 range. Analyst Commentary Recent Street research on GRAIL highlights a split view.
お知らせ • Jul 30GRAIL, Inc. to Report Q2, 2026 Results on Aug 05, 2026GRAIL, Inc. announced that they will report Q2, 2026 results After-Market on Aug 05, 2026
ナラティブ更新 • Jul 20GRAL: Future Reimbursement Progress Will Drive Confidence Despite Trial And Legal HeadwindsGRAIL's analyst price target has shifted from $80 to $88, with analysts citing large addressable markets, strong volume trends, and improving pricing, while still acknowledging a more challenging near-term risk and reward setup and a mixed sector backdrop. Analyst Commentary Recent Street research on Grail reflects a mix of optimism around the company’s testing portfolio and caution around sector and reimbursement risks.
ライブニュース • Jul 17GRAIL Expands Galleri Cancer Test Access With Priority Health Employer Coverage In MichiganGRAIL announced a collaboration with Priority Health to offer its Galleri multi-cancer early detection blood test to Priority Health’s self-insured employer groups, extending prior availability beyond Medicare Advantage plans and making Priority Health the first Michigan health plan to cover Galleri for employer groups. The expansion into employer health plans widens potential access to Galleri, giving GRAIL another channel to reach commercially insured patients through workplace benefits rather than relying only on Medicare Advantage coverage. GRAIL’s stock last traded at US$71.96, with the share price up 39.2% over the past 90 days, while the news reflects further commercial traction for its Galleri testing offering. The key takeaway is that broader employer coverage could support wider use of GRAIL’s test, while also introducing execution risks related to employer uptake, clinical integration, and long-term reimbursement support.
ナラティブ更新 • Jul 06GRAL: Future Reimbursement Progress Will Drive Confidence After Trial SetbackThe updated analyst price target for GRAIL has shifted from $130 to $80, reflecting a more cautious stance from analysts who highlight regulatory uncertainty around multi cancer early detection tests and the need for clearer reimbursement support before the story can fully play out. Analyst Commentary Recent Street research on Grail has centered on how quickly the company can broaden use of its Galleri multi cancer early detection test beyond the self pay market and into reimbursed channels.
ライブニュース • Jul 01GRAIL Faces Securities Fraud Suit After Cancer Trial Disclosures QuestionedGRAIL, Inc. and certain senior executives are facing a securities fraud class action in the U.S. District Court for the Northern District of California, alleging they misrepresented the design and results of the NHS-Galleri cancer detection trial and its failure to meet the primary endpoint of reducing late-stage cancers, following a stock price decline of more than 50%. The complaint also claims GRAIL did not disclose concerns that the trial duration might be too short to show the intended endpoint, and investors who believe they were harmed have until August 4, 2026, to seek to join the lawsuit. GRAIL’s stock last traded at US$68.27, with the share price down 23.2% year to date, which illustrates how legal and disclosure risks can feed directly into valuation pressure and raise the bar for investor confidence in clinical data.
お知らせ • Jun 26GRAIL, Inc. announced that it has received $110.000075 million in funding from Samsung Electronics Co., Ltd., Samsung Electronics Singapore Pte. Ltd., Samsung C&T CorporationOn June 25, 2026, GRAIL, Inc. closed the transaction.
ライブニュース • Jun 22Grail Faces Class Action Over NHS-Galleri Trial Disclosures and Data ConcernsMultiple law firms have launched a securities class action against GRAIL, alleging the company made false and misleading statements about its NHS-Galleri cancer detection trial between May 13, 2025 and February 19, 2026, including claims it concealed adverse internal data and misrepresented the trial’s design and timeframe. The lawsuit follows disclosures that the NHS-Galleri trial did not meet its primary endpoint of reducing late-stage (Stage III–IV) cancers, after which GRAIL’s stock reportedly fell about 50% in one session, creating substantial claimed losses for shareholders in the defined class period. GRAIL shares most recently traded at $63.74, with the stock down 28.3% year to date, indicating a period of pressure as the company faces both clinical questions and securities litigation risk. This type of suit can be lengthy and costly, and it adds an extra layer of uncertainty on top of trial outcomes that are central to GRAIL’s business model.
ナラティブ更新 • Jun 22GRAL: Future Returns Will Hinge On Trial Outcomes And Reimbursement ClarityThe GRAIL analyst price target has been modestly reset, slipping from $66.86 to $66.00 as analysts factor in a slightly higher discount rate and ongoing uncertainty around regulatory review and payor reimbursement for the Galleri test. Analyst Commentary Recent Street research on GRAIL points to a cautious but engaged stance, with Goldman Sachs and several other firms sitting at the middle of the spectrum as they weigh the commercial opportunity for the Galleri test against open questions on regulation and reimbursement.
分析記事 • Jun 20GRAIL (GRAL) Stock Could Be 4.7% Undervalued After NHS Galleri Trial SetbackGRAIL (GRAL) is under pressure after disclosing that its NHS Galleri trial did not achieve the expected statistically significant reduction in late stage cancers, triggering multiple securities class action lawsuits and sharp investor concern. See our latest analysis for GRAIL. The failed NHS Galleri trial and subsequent lawsuits came after a sharp one day drop earlier in the year. Since then, the stock has shown mixed momentum, with a 90 day share price return of 36.08%, a year to date share...
ライブニュース • Jun 10Grail Faces Investor Lawsuits Over Alleged Misleading Cancer Trial DisclosuresMultiple law firms have filed securities class action lawsuits against Grail, Inc. on behalf of investors who bought GRAL between May 13, 2025 and February 19, 2026. The suits allege Grail made false and misleading statements about the effectiveness and primary endpoint results of its NHS-Galleri cancer screening trial. Investors are being encouraged to seek compensation and to consider moving for lead plaintiff status, with an August 4, 2026 deadline to participate. The key issue is whether Grail’s disclosures around the NHS-Galleri trial results were sufficiently accurate and complete, which now sits at the center of this litigation. Investors considering GRAL or already holding it may want to track legal updates and company communications closely, since class action outcomes can affect legal costs, management focus and market perception.
ナラティブ更新 • Jun 04GRAL: Future Returns Will Reflect Trial Evidence And Reimbursement ProgressGRAIL's analyst price target has been reduced by about $1 per share as analysts factor in more balanced assumptions on reimbursement progress, profitability, and long-term P/E expectations, following a mix of cautious initiations and price target changes across the Street. Analyst Commentary Recent Street research on GRAIL points to a more balanced stance, with a mix of cautious initiations, price target reductions, and a smaller number of positive adjustments that keep expectations in check.
お知らせ • Jun 02+ 1 more updateGRAIL, Inc. Reports Full Results From NHS-Galleri Trial Demonstrating Substantial Reduction In Stage IV Cancer DiagnosesGRAIL, Inc. announced detailed clinical utility, performance and safety results from its landmark NHS-Galleri trial in an oral presentation at the 2026 American Society of Clinical Oncology Annual Meeting. The NHS-Galleri trial is the first and only randomized, controlled trial of a multi-cancer early detection (MCED) test and evaluated annual screening with the Galleri test in England's National Health Service (NHS) over three years in 142,250 demographically representative participants aged 50 to 77 at enrollment. The NHS-Galleri trial evaluated a combined primary endpoint of Stage III and IV diagnoses in a pre-specified group of 12 deadly cancers when the Galleri test was added to standard of care screening in England (breast, bowel, cervical and high risk lung cancers) versus standard of care screening alone; however, there was no statistically significant difference within a 1-year follow up window after the last appointment. Follow-up will continue, with further results published as available. One of the aims of screening is to reduce the incidence of metastatic late stage cancer. In the Galleri arm, Stage IV cancer diagnoses decreased with each year of sequential screening, with a 9% reduction in the first screening round, a 22% reduction in the second round, and a 26% reduction in the third round in the pre-specified group of 12 cancers. The prevalent round detects undiagnosed cancers already present in the population at the time of initial screening, while subsequent incident rounds detect cancers that develop or progress between screening rounds and become detectable. Thus, the incident rounds most closely approximate the likely steady-state impact of an annual screening program. Overall, in this pre-specified secondary endpoint, a 14% reduction in Stage IV cancers was observed. These results were nominally statistically significant. Similar reductions of 20% or more were observed in the second and third screening rounds for all stageable cancers. Within the overall trend of Stage IV reduction, in an exploratory analysis, meaningful reductions in Stage IV diagnoses were observed in cancer types where 5-year survival is substantially higher when diagnosed at Stage III versus IV. For example, Stage IV diagnoses were reduced by 57.1% in esophageal cancer and 34.4% in colorectal cancer in the incident rounds. The five-year survival rates in England are significantly higher in Stage III than Stage IV for each of these cancers: 24.7% vs 6.2% for esophageal cancer, 64.2% vs 11.0% for colorectal cancer. Relative Incidence Rate of Combined Stage III/IV Cancers Decreased After the First Round of Screening in the Pre-Specified Group of 12 Cancers; Relative Incidence Rate of Stage IV Cancers Decreased Each Screening Round. Stage III/IV Cancers Diagnosed Incidence Rate Ratio Intervention vs Control (% Difference): After 3 Screening Rounds 1.03 (0.92, 1.14) ?3%, p=0.6324; First Screening Round (Prevalent) 1.19 (0.98, 1.43) ?19%; Second Screening Round (Incident) 0.95 (0.77, 1.17) ?5%; Third Screening Round (Incident) 0.88 (0.73, 1.07) ?12%. Stage IV Cancers Diagnosed Incidence Rate Ratio Intervention vs Control (% Difference): After 3 Screening Rounds 0.86 (0.744, 0.998) ?14%; First Screening Round (Prevalent) 0.91 (0.71, 1.18) ?9%; Second Screening Round (Incident) 0.78 (0.57, 1.06) ?22%; Third Screening Round (Incident) 0.74 (0.57, 0.95) ?26%. Along with the decrease in Stage IV cancer incidence, Stage I and II cancers diagnosed increased by 16% for the 12 prespecified cancer types after three rounds of screening, including large increases in many types typically diagnosed late, such as ovarian, esophageal, pancreatic and liver cancers. The addition of the Galleri test to standard-of-care cancer screenings led to a four-fold increase in screen-detected cancers and a 21% decrease in the number of clinically detected cancers after symptomatic presentation. Further, the addition of MCED screening was associated with cancers diagnosed after emergency presentation decreasing by 25%. 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. Over three screening rounds, 1,801 participants (0.91%) had a positive MCED test result and 937 were diagnosed with cancer, for a cancer detection rate of 0.48%. PPV was 52.0% overall and 58.0% in the first screening round. Specificity was 99.55%, resulting in a low false positive rate of 0.45%. CSO accuracy was 92.5%. Episode sensitivity – the ability to detect cancers that were diagnosed within 12 months after each Galleri screening blood draw - was 54.7% for the 12 prespecified cancer types and 30.7% across all cancer types. There were no serious related adverse events reported in the trial, reaffirming the safety profile of the test. The results of the NHS-Galleri trial will be submitted for publication in a peer-reviewed medical journal.
分析記事 • May 08Here's What Analysts Are Forecasting For GRAIL, Inc. (NASDAQ:GRAL) After Its First-Quarter ResultsA week ago, GRAIL, Inc. ( NASDAQ:GRAL ) came out with a strong set of first-quarter numbers that could potentially lead...
ナラティブ更新 • May 07GRAL: Future Returns Will Reflect Trial Outcomes And Reimbursement ProgressNarrative Update on GRAIL Analysts have trimmed their average price target for GRAIL by incorporating lower profit margin assumptions and a slightly higher future P/E of about 101x, following mixed reactions to recent study readouts and reimbursement uncertainty. Analyst Commentary Recent research updates on GRAIL reflect a split tape, with some firms trimming price targets after the NHS Galleri readout and reimbursement uncertainty, while others still see room for upside based on the company’s test portfolio and addressable market.
Reported Earnings • May 06First quarter 2026 earnings: EPS and revenues exceed analyst expectationsFirst quarter 2026 results: US$2.29 loss per share (improved from US$3.10 loss in 1Q 2025). Revenue: US$40.8m (up 28% from 1Q 2025). Net loss: US$93.2m (loss narrowed 12% from 1Q 2025). Revenue exceeded analyst estimates by 4.2%. Earnings per share (EPS) also surpassed analyst estimates by 17%. Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US.
お知らせ • Apr 30GRAIL, Inc., Annual General Meeting, Jun 18, 2026GRAIL, Inc., Annual General Meeting, Jun 18, 2026.
Board Change • Apr 29High number of new and inexperienced directorsThere are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. No experienced directors. No highly experienced directors. Independent Director Bill Chase is the most experienced director on 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 board continuity. Lack of experienced directors.
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
ナラティブ更新 • Apr 19GRAL: Future Returns Will Depend On Upcoming FDA Approval DecisionAnalysts have trimmed GRAIL's average price target to about $67.71 from $72.40. They cited updated models that factor in recent price target cuts following the NHS-Galleri topline readout and lingering uncertainty around broad reimbursement, even as revenue growth and margin assumptions are slightly adjusted.
Recent Insider Transactions • Apr 17CEO & Director recently sold US$6.2m worth of stockOn the 8th of April, Robert Ragusa sold around 124k shares on-market at roughly US$49.92 per share. This transaction amounted to 29% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Robert has been a net seller over the last 12 months, reducing personal holdings by US$15m.
Recent Insider Transactions Derivative • Apr 08CEO & Director notifies of intention to sell stockRobert Ragusa intends to sell 133k shares in the next 90 days after lodging an Intent To Sell Form on the 6th of April. If the sale is conducted around the recent share price of US$51.74, it would amount to US$6.9m. For the year to December 2022, Robert's total compensation was 10% salary and 90% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since June 2025, Robert's direct individual holding has increased from 205.85k shares to 218.25k. Company insiders have collectively sold US$23m more than they bought, via options and on-market transactions in the last 12 months.
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.
ナラティブ更新 • Apr 05GRAL: Future Returns Will Hinge On Upcoming Regulatory And Coverage MilestonesNarrative Update on GRAIL The analyst price target for GRAIL has been reduced by $11.00. This change reflects recent cuts across firms citing the NHS Galleri study missing its primary endpoint and greater uncertainty around broad reimbursement, even as analysts still reference GRAIL's position in multi cancer early detection and upcoming regulatory and coverage milestones.
Price Target Changed • Mar 29Price target decreased by 18% to US$72.40Down from US$88.00, the current price target is an average from 5 analysts. New target price is 49% above last closing price of US$48.49. Stock is up 80% over the past year. The company is forecast to post a net loss per share of US$11.02 next year compared to a net loss per share of US$11.11 last year.
ナラティブ更新 • Mar 21GRAL: Future Returns Will Depend On NHS Study OutcomeNarrative Update: GRAIL Analyst Price Target Shift The updated analyst fair value estimate for GRAIL has moved from $88.00 to $83.40 as analysts factor in lower published price targets following the NHS Galleri study missing its primary endpoint and increased uncertainty around broad reimbursement, while still modeling higher revenue, stronger profit margins, and a lower future P/E multiple. Analyst Commentary Recent Street research shows a mix of optimism and caution around GRAIL, with several firms revising price targets after the NHS Galleri study update and recent quarterly results.
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.
Recent Insider Transactions • Mar 11CEO & Director recently sold US$409k worth of stockOn the 9th of March, Robert Ragusa sold around 8k shares on-market at roughly US$48.48 per share. This transaction amounted to 1.3% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Robert has been a net seller over the last 12 months, reducing personal holdings by US$7.4m.
新しいナラティブ • Mar 08Clinical Trial Setbacks And Reimbursement Delays Will Eventually Support Early Cancer Detection PotentialCatalysts About GRAIL GRAIL focuses on multi cancer early detection through its Galleri screening test and related clinical programs. What are the underlying business or industry changes driving this perspective?
ナラティブ更新 • Mar 06GRAL: Future Returns Will Hinge On NHS Study And FDA DecisionThe analyst fair value estimate for Grail has been trimmed from $114.50 to $88.00 as analysts factor in lower revenue growth and profit margin assumptions following the NHS Galleri readout and increased uncertainty around broad reimbursement. Analyst Commentary Street research on Grail has shifted meaningfully following the NHS Galleri top line readout, with several firms reducing price targets and reassessing the risk and reward profile around Galleri adoption and reimbursement.
Recent Insider Transactions Derivative • Mar 03CEO & Director notifies of intention to sell stockRobert Ragusa intends to sell 41k shares in the next 90 days after lodging an Intent To Sell Form on the 2nd of March. If the sale is conducted around the recent share price of US$53.23, it would amount to US$2.2m. For the year to December 2022, Robert's total compensation was 10% salary and 90% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2025, Robert's direct individual holding has increased from 127.65k shares to 173.43k. Company insiders have collectively sold US$20m more than they bought, via options and on-market transactions in the last 12 months.
新しいナラティブ • Feb 22NHS Trial Momentum And Medicare Pathway Will Support Long Term Multi Cancer Screening AdoptionCatalysts About GRAIL GRAIL develops and commercializes Galleri, a blood based multi cancer early detection test aimed at finding cancers at earlier stages. What are the underlying business or industry changes driving this perspective?
Price Target Changed • Feb 22Price target decreased by 13% to US$101Down from US$115, the current price target is an average from 4 analysts. New target price is 100% above last closing price of US$50.21. Stock is up 23% over the past year. The company is forecast to post a net loss per share of US$10.95 next year compared to a net loss per share of US$11.11 last year.
New Risk • Feb 21New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 12% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings are forecast to decline by an average of 3.7% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$539m net loss in 3 years). Shareholders have been diluted in the past year (19% increase in shares outstanding). Significant insider selling over the past 3 months (US$7.6m sold).
Reported Earnings • Feb 20Full year 2025 earnings: EPS exceeds analyst expectationsFull 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 was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 2.6%. Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US.
ナラティブ更新 • Feb 20GRAL: Future Returns Will Hinge On Upcoming NHS Trial ReadoutThe average analyst price target for Grail has edged down by $0.50 to about $114.50, as analysts balance optimism around upcoming trial readouts and potential regulatory milestones with a more cautious stance after the stock's very large move earlier in 2025 and ongoing execution risks. Analyst Commentary Recent research on Grail reflects a mix of enthusiasm for its position in multi cancer early detection and caution around valuation and execution timelines.
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
ナラティブ更新 • Feb 04GRAL: Future Returns Will Depend On NHS Readout And Execution ConsistencyNarrative Update Analysts have lifted their price target on GRAIL from $105 to $115, citing refreshed models that reflect updated assumptions for growth, margins and future P/E. Recent research highlights steady execution, the long term Galleri opportunity, and the absence of thesis changing developments in recent results.
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.
ナラティブ更新 • Jan 20GRAL: Future Returns Will Hinge On NHS Trial And Execution RisksAnalysts have nudged their price target on GRAIL up to $110 from $85, citing steady execution, a modest Q4 revenue beat, and the longer term opportunity for the Galleri test, despite the inherent risks that come with new technologies. Analyst Commentary Analysts see GRAIL's recent results as an incremental step rather than a major reset, with views split between confidence in execution and caution around key milestones like the NHS Galleri trial readout.
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.
ナラティブ更新 • Jan 06GRAL: Long Term MCED Opportunity And Execution Risks Will Shape Future ReturnsAnalysts have raised their price target range for GRAIL to about $85 from around $38, citing updated post-Q3 estimates and what they view as a significant long-term commercial opportunity for the Galleri multi-cancer early detection test, while also highlighting the risks associated with this type of novel technology. Analyst Commentary Bullish Takeaways Bullish analysts see the increase in the price target range to about $85 as a reflection of what they view as a sizeable commercial runway for the Galleri multi cancer early detection test over the long term.
ナラティブ更新 • Dec 16GRAL: Future MCED Policy Shifts Will Drive Upside Despite Execution RisksAnalysts have raised their price target on GRAIL to $105 from $96.67, citing updated post earnings estimates and growing confidence in the long term commercial potential of the Galleri multi cancer early detection platform, despite ongoing technology and regulatory risks. Analyst Commentary Recent Street research reflects a meaningful reset in expectations for GRAIL, with multiple price target increases grounded in updated post earnings models and a clearer view of Galleri's commercial runway.
Recent Insider Transactions • Dec 07CEO & Director recently sold US$3.8m worth of stockOn the 3rd of December, Robert Ragusa sold around 40k shares on-market at roughly US$95.24 per share. This transaction amounted to 19% 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 US$5.1m. Robert has been a net seller over the last 12 months, reducing personal holdings by US$7.8m.
Recent Insider Transactions Derivative • Dec 04Chief Financial Officer notifies of intention to sell stockAaron Freidin intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 3rd of December. If the sale is conducted around the recent share price of US$99.15, it would amount to US$2.5m. Since March 2025, Aaron's direct individual holding has increased from 45.05k shares to 78.95k. Company insiders have collectively sold US$13m more than they bought, via options and on-market transactions in the last 12 months.
ナラティブ更新 • Dec 01GRAL: Risks From Clinical Data and Execution Will Remain a Key ConcernAnalysts have raised their price target for GRAIL from approximately $90 to $97 per share, citing strengthened confidence in the company’s long-term growth prospects. This outlook is driven by recent developments and opportunities in multi-cancer early detection.
ナラティブ更新 • Nov 17GRAL: Confidence Will Increase With Upcoming Clinical Data and Legislative ProgressAnalysts have raised their price target for GRAIL from $61.50 to $90.00. This change reflects increased confidence in the company’s long-term prospects and growth potential, following recent updates and a positive outlook on its multi-cancer early detection technology.
New Risk • Nov 14New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 16% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 3.8% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$538m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (16% increase in shares outstanding). Significant insider selling over the past 3 months (US$5.7m sold).
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: EPS and revenues exceed analyst expectationsThird 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 exceeded analyst estimates by 2.2%. Earnings per share (EPS) also surpassed analyst estimates by 29%. Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US.
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.
ナラティブ更新 • Nov 01GRAL: Execution Risks Remain High Amid PATHFINDER 2 Progress And Regulatory ShiftsAnalysts have raised GRAIL's fair value estimate from $56.50 to $61.50 per share, citing greater confidence in the company's platforms, ongoing clinical milestones, and evolving market opportunities as key drivers for the upward revision. Analyst Commentary Bullish Takeaways Bullish analysts highlight growing confidence in GRAIL's platforms.
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.
ナラティブ更新 • Oct 18FDA Approval And NHS Studies Will Transform Cancer DetectionAnalysts have raised their price target on GRAIL significantly, from $43 to $75. They cite growing confidence in the company's platforms, anticipated improvements in test performance, and the potential impact of future legislative changes as reasons for this adjustment.
Recent Insider Transactions • Oct 18CEO & Director recently sold US$499k worth of stockOn the 15th of October, Robert Ragusa sold around 7k shares on-market at roughly US$68.88 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 US$5.1m. Robert has been a net seller over the last 12 months, reducing personal holdings by US$4.0m.
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 Derivative • Oct 16President notifies of intention to sell stockJoshua Ofman intends to sell 15k shares in the next 90 days after lodging an Intent To Sell Form on the 15th of October. If the sale is conducted around the recent share price of US$69.29, it would amount to US$1.0m. Since March 2025, Joshua's direct individual holding has increased from 76.44k shares to 166.72k. Company insiders have collectively sold US$12m more than they bought, via options and on-market transactions in the last 12 months.
Recent Insider Transactions • Oct 10President recently sold US$5.1m worth of stockOn the 6th of October, Joshua Ofman sold around 81k shares on-market at roughly US$62.50 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 US$6.9m.
ナラティブ更新 • Oct 04FDA Approval And NHS Studies Will Transform Cancer DetectionAnalysts have raised their price target for GRAIL from $40.50 to $56.50. They cite strengthened confidence in the company's platforms, positive expectations for future study results, and anticipation of supportive legislative developments.
Recent Insider Transactions Derivative • Oct 03President notifies of intention to sell stockJoshua Ofman intends to sell 10k shares in the next 90 days after lodging an Intent To Sell Form on the 2nd of October. If the sale is conducted around the recent share price of US$62.06, it would amount to US$601k. Since December 2024, Joshua's direct individual holding has increased from 72.25k shares to 104.99k. Company insiders have collectively sold US$9.0m more than they bought, via options and on-market transactions in the last 12 months.
New Risk • Sep 29New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 0.2% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$501m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (16% increase in shares outstanding).
Reported Earnings • Aug 13Second quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behindSecond 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 missed analyst estimates by 3.7%. Earnings per share (EPS) exceeded analyst estimates by 13%. Revenue is forecast to grow 19% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US.
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
Recent Insider Transactions Derivative • Jul 16Chief Financial Officer notifies of intention to sell stockAaron Freidin intends to sell 8k shares in the next 90 days after lodging an Intent To Sell Form on the 15th of July. If the sale is conducted around the recent share price of US$40.18, it would amount to US$321k. Since September 2024, Aaron's direct individual holding has increased from 15.01k shares to 83.87k. Company insiders have collectively sold US$10m more than they bought, via options and on-market transactions in the last 12 months.
Recent Insider Transactions Derivative • Jul 01President notifies of intention to sell stockJoshua Ofman intends to sell 10k shares in the next 90 days after lodging an Intent To Sell Form on the 30th of June. If the sale is conducted around the recent share price of US$48.39, it would amount to US$469k. Since September 2024, Joshua's direct individual holding has increased from 72.25k shares to 110.81k. Company insiders have collectively sold US$10m more than they bought, via options and on-market transactions in the last 12 months.
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.
新しいナラティブ • Jun 15Overvaluation Risks And NHS Trials Will Spur Future Resilience Market optimism may overestimate Galleri's near-term adoption and pricing power due to regulatory, payer, and competitive pressures.
Recent Insider Transactions Derivative • Jun 13President notifies of intention to sell stockJoshua Ofman intends to sell 10k shares in the next 90 days after lodging an Intent To Sell Form on the 12th of June. If the sale is conducted around the recent share price of US$43.87, it would amount to US$425k. Since June 2024, Joshua's direct individual holding has increased from 7.93k shares to 120.50k. Company insiders have collectively sold US$10m more than they bought, via options and on-market transactions in the last 12 months.
Reported Earnings • May 14First quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behindFirst quarter 2025 results: US$3.10 loss per share. Revenue: US$31.8m (up 19% from 1Q 2024). Net loss: US$106.2m (loss narrowed 52% from 1Q 2024). Revenue missed analyst estimates by 9.6%. Earnings per share (EPS) exceeded analyst estimates by 22%. Revenue is forecast to grow 18% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US.
Recent Insider Transactions • May 08CEO & Director recently sold US$3.2m worth of stockOn the 2nd of May, Robert Ragusa sold around 94k shares on-market at roughly US$33.93 per share. This transaction amounted to 31% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Robert has been a net seller over the last 12 months, reducing personal holdings by US$5.2m.
Recent Insider Transactions Derivative • May 01CEO & Director notifies of intention to sell stockRobert Ragusa intends to sell 96k shares in the next 90 days after lodging an Intent To Sell Form on the 1st of May. If the sale is conducted around the recent share price of US$36.81, it would amount to US$3.5m. For the year to December 2022, Robert's total compensation was 10% salary and 90% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since June 2024, Robert's direct individual holding has increased from 857.00 shares to 127.65k. Company insiders have collectively sold US$4.1m more than they bought, via options and on-market transactions in the last 12 months.
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.
Recent Insider Transactions • Mar 16CEO & Director recently sold US$238k worth of stockOn the 7th of March, Robert Ragusa sold around 8k shares on-market at roughly US$31.21 per share. This transaction amounted to 6.3% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Robert has been a net seller over the last 12 months, reducing personal holdings by US$2.0m.
Reported Earnings • Feb 21Full year 2024 earnings: EPS and revenues exceed analyst expectationsFull 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 exceeded analyst estimates by 2.7%. Earnings per share (EPS) also surpassed analyst estimates by 4.7%. Revenue is forecast to grow 14% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US.
New Risk • Feb 13New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 19% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (19% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$608m net loss in 3 years). Significant insider selling over the past 3 months (US$427k sold).
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
Seeking Alpha • Jan 22GRAIL: Cash Burn And Commercialization Timeline Are ProblematicSummary GRAIL is a developer of blood-based cancer tests and is initially targeting the multi-cancer early detection market. This market will be large due to the prevalence of cancer, along with the lack of screening options for some cancers and poor compliance rates with current screening methods. GRAIL's flagship product, Galleri, has enormous potential but faces competition and is years away from generating meaningful revenue. Regulatory approval and reimbursement are critical, with key trials ongoing in support of this. Read the full article on Seeking Alpha
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.
分析記事 • Dec 24Here's Why We're Watching GRAIL's (NASDAQ:GRAL) Cash Burn SituationThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, although Amazon.com...
New Risk • Dec 18New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$572m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Significant insider selling over the past 3 months (US$2.2m sold).
Seeking Alpha • Dec 16Grail: Lack Of Near Term Catalyst; Market Likely To Lose Interest SoonSummary Grail's net cash balance of $25.71 per share suggests potential undervaluation as it trades at ~$21 per share. However, this cash balance is already part of ongoing expenditure. The risk of failing current NHS trials further complicates the investment outlook. Given these factors, entry at current prices is not favorable. Read the full article on Seeking Alpha
Recent Insider Transactions • Nov 21Chief Financial Officer recently sold US$427k worth of stockOn the 18th of November, Aaron Freidin sold around 30k shares on-market at roughly US$14.02 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 US$1.7m. Aaron has been a net seller over the last 12 months, reducing personal holdings by US$681k.
