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GRAIL highlights Galleri growth ahead of key FDA advisory meeting. August 14, 2026 GRAIL NASDAQ: GRAL Chief Financial Officer Aaron Freidin said the company's Galleri multi-cancer early detection test recorded strong first-half growth as it expanded distribution through digital health platforms, employers and physician offices. Speaking at the Canaccord Genuity Growth Conference, Freidin said GRAIL generated approximately 30% revenue growth and 42% test-volume growth in the first half, with more than 117,000 tests completed. The company has been focused on building a market for Galleri through self-pay and reimbursement-related channels, including digital health providers, self-insured employers and traditional physician practices. "The things really driving growth right now are traction in those channels, and then the education of those sales reps now having the ASCO data in hand," Freidin said, referring to data from the NHS-Galleri study presented at the American Society of Clinical Oncology meeting. Sales force and digital health expansion. GRAIL expanded its sales force during the second quarter and completed training by the end of the period, Freidin said. Sales representatives have also been trained on the NHS-Galleri results and are using the data in physician discussions. The company's integrations with Quest Diagnostics and athenahealth have been in place for more than a year, according to Freidin. He said ordering becomes easier once physicians are familiar with the test and have experience detecting cancers through it. GRAIL expects to integrate with Epic by the end of the year, which Freidin said should further reduce ordering friction. Discover more Stock profit calculator Stock market news Digital health represents a significant opportunity, he said. GRAIL's partner Function targets consumers who are proactive about their health, a customer profile that aligns with cancer screening before symptoms emerge. Freidin said digital-health channel volumes doubled year over year on a quarterly basis. GRAIL also launched with Hims & Hers earlier in the year, though Freidin said that company's attention has been more focused on its GLP-1 business than its laboratory offerings. He characterized additional investment by Hims & Hers in its labs business as a potential source of future upside. Pricing, margins and capacity. Galleri's patient-pay price is about $950, while GRAIL reported an average selling price of roughly $700 per test, according to the conference discussion. Freidin said the company began using volume-based contracts with physicians, health systems and employers last year, lowering prices as volumes rise. He said GRAIL expects the eventual Centers for Medicare & Medicaid Services reimbursement rate to be around $500. At that price, the company believes it can operate with gross margins of 50% to 60% at scale using the current version of its test. GRAIL's laboratory can process more than 1 million tests annually, Freidin said, compared with an implied annualized volume of about 240,000 tests based on first-half activity. The company is therefore focused on gaining leverage from its fixed-cost infrastructure. He described the lab as highly automated, with limited manual handling after sample tubes enter the processing workflow. FDA review and clinical data. Freidin said GRAIL's upcoming Food and Drug Administration advisory committee meeting is expected to focus on Galleri's performance and efficacy data. The company submitted Galleri for premarket approval in January 2026, and the advisory committee meeting is scheduled for Sept. 23. He said GRAIL has had an "iterative and collaborative" review process with the FDA and expects the advisory committee discussion to address measures such as positive predictive value, specificity and cancer signal detection rate. Freidin said the company is preparing for a range of possible outcomes from the meeting. GRAIL has emphasized results from the NHS-Galleri trial, which did not meet its primary endpoint but showed more than a 20% reduction in stage IV cancers, according to Freidin. The study also found more stage I and II cancers, and he said the results reflected a greater-than-expected amount of stage III cancer already present in the population at baseline. Freidin said the findings have resonated with oncologists because earlier-stage cancers may more often be treated with curative intent. He added that the company plans an additional 12 months of follow-up in the NHS-Galleri study, with data expected in the first half of 2027. A nested mortality analysis is expected to read out sometime in 2028. The company also submitted results from its PATHFINDER 2 study to the FDA. Freidin said the study, which included about 35,000 participants, showed that Galleri's performance in an intended-use screening population remained consistent with or improved from the earlier PATHFINDER study. Reimbursement and international plans. Freidin said GRAIL is in early discussions with CMS regarding potential national coverage after FDA approval. He said the REACH study, designed for the Medicare population, will be important to those discussions because it is evaluating clinical utility and reductions in late-stage disease. The study was originally designed to read out in 2030 or 2031, although GRAIL may provide data along the way. Internationally, GRAIL is discussing next steps with the U.K.'s National Health Service. Freidin said the NHS has reviewed the data, but decisions will also involve political and budget considerations and are not expected to move quickly. The company also completed a $110 million financing associated with its Samsung agreement in June. The arrangement will initially involve Samsung establishing a sales force in Korea and selling Galleri tests into that self-pay market, with samples sent back to GRAIL. If the initial phase is successful and GRAIL receives FDA approval, the partnership could expand to Japan and potentially include a laboratory buildout. GRAIL ended the quarter with about $900 million in cash, Freidin said. The company expects cash burn of less than $300 million for the year but may continue investing in sales and commercial infrastructure if demand proves durable ahead of broader reimbursement. About GRAIL (NASDAQ:GRAL). GRAIL, Inc NASDAQ: GRAL is a biotechnology company dedicated to the early detection of cancer through a multi-cancer blood test. Leveraging advances in next-generation sequencing, cell-free DNA (cfDNA) analysis and machine learning, GRAIL has developed the Galleri(TM) test, which aims to identify more than 50 types of cancer at their earliest stages. The company's platform analyzes methylation patterns in circulating tumor DNA to pinpoint tumor presence and tissue of origin, enabling physicians to pursue timely diagnostic follow-up. Founded in 2016 as a spin-out from Illumina, GRAIL established its headquarters in Menlo Park, California, with additional research and operations centers in the United Kingdom. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. Continue following MarketBeat Before you consider GRAIL, you'll want to hear this. 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GRAIL reported second-quarter revenue of $44.7 million, up 26% year-over-year, driven by higher Galleri test volumes. The company sold more than 61,000 Galleri tests during the quarter, a 35% increase from the prior year. Screening revenue contributed $42.6 million, up 24%, whilst development services revenue totalled $2 million. For the first half of the year, screening revenue exceeded $80 million, up 30%, with test volume surpassing 117,000 tests. GRAIL reported a net loss of $110.2 million, down 3% from the previous year. The company ended the quarter with $861.6 million in cash, including a $110 million investment from Samsung that closed in June. The company has submitted its premarket approval application to the FDA and expects an advisory committee review in autumn.

$GRAL securities: suffer losses on your GRAIL, Inc. investment? BFA Law reminds investors of the Securities Fraud lawsuit to recover losses. A securities fraud class action lawsuit has been filed on behalf of GRAIL investors after its stock plummeted 50% because GRAIL allegedly misled investors relating to GRAIL's NHS-Galleri cancer trial, potentially violating federal securities laws. NEW YORK, July 31, 2026 (GLOBE NEWSWIRE) - Leading securities law firm Bleichmar Fonti & Auld LLP announces that a class action lawsuit has been filed against GRAIL, Inc. (NASDAQ:GRAL) and certain of the Company's senior executives for securities fraud after its significant stock drop resulting from potential violations of the federal securities laws. If you invested in GRAIL, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases/grail-class-action-lawsuit. Key Details of the GRAIL ($GRAL) Class Action: * Lead Plaintiff Deadline: August 4, 2026 * Alleged Misconduct: Securities fraud relating to GRAIL's NHS-Galleri cancer trial * Stock Drop: February 20, 2026 - 50.55% Stock Drop * Court: U.S. District Court for the Northern District of California * Action: Contact BFA Law to discuss your rights Investors have until August 4, 2026 to ask the Court to be appointed to lead the case. The complaint asserts securities fraud claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors in GRAIL common stock. The class action is pending in the U.S. District Court for the Northern District of California. It is captioned Robbins v. GRAIL, Inc., et al., No. 26-cv-05428. Why is GRAIL Being Sued for Securities Fraud? GRAIL is a commercial-stage healthcare company focused on early cancer detection. GRAIL developed Galleri, a multi-cancer early detection test that analyzes blood samples to screen for multiple cancers, identify the likely organ or tissue of origin, and assist in the screening process. As part of GRAIL's efforts to attain an accelerated implementation of its test as a national screening program through the United Kingdom's National Health Service ("NHS"), GRAIL conducted the "NHS-Galleri trial." The primary objective of the NHS-Galleri trial was "to show a reduction in late-stage (III-IV) cancers in people who received the Galleri test compared with those who did not." According to the complaint, during the relevant period, GRAIL made positive statements about Galleri, the NHS-Galleri trial design, and top-line results from the first screening round, including that the NHS-Galleri trial was "designed with three consecutive years of screening in order to achieve the primary endpoint," and that "Galleri is working in the real world." As alleged, in truth, the NHS-Galleri trial's three-year timeframe was insufficient to demonstrate the primary endpoint. Why did GRAIL's Stock Drop? On February 19, 2026, GRAIL announced top-line results from its NHS-Galleri trial. Although the Company emphasized certain favorable results, GRAIL disclosed that the trial did not meet its primary endpoint. Specifically, GRAIL stated that the "primary endpoint of statistically significant Stage III-IV reduction was not observed." GRAIL attributed the disappointing outcome, in part, to "probably need[ing] a longer follow-up time to be able to [compare the two arms of the study] adequately." This news caused the price of GRAIL stock to decline $51.32 per share, or 50.55%, from a closing price of $101.53 per share on February 19, 2026, to $50.21 per share on February 20, 2026. What Can You Do? If you invested in GRAIL, you may have legal options and are encouraged to submit your information to the firm. All representation is on a contingency fee basis; there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses. Submit your information by visiting: Why Bleichmar Fonti & Auld LLP? BFA is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It has been named a top plaintiff law firm by Chambers USA, The Legal 500, and ISS SCAS, and its attorneys have been named "Elite Trial Lawyers" by the National Law Journal, "Litigation Stars" by Benchmark Litigation, among the top "500 Leading Plaintiff Financial Lawyers" by Lawdragon, "Titans of the Plaintiffs' Bar" by Law360 and "SuperLawyers" by Thomson Reuters. Most recently, The Legal 500 awarded BFA the most client satisfaction accolades of any plaintiff's securities litigation law firm, with clients noting: "[t]here is no better service provider in the practice area," "[t]he interest of the client is always front and center," and "[t]here isn't a better firm in this space." One testimonial described the firm as "nimble and entrepreneurial," with a "relentless focus on adding value for clients." Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.'s Board of Directors, as well as $420 million from Teva Pharmaceutical Ind. Ltd. Attorney advertising. Past results do not guarantee future outcomes. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. Today in New York do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. 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