4 - Guardant Health, Inc. (0001576280) (Issuer)

For Immediate Release: July 30, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA is announcing the fiscal year (FY) 2025 user fee rates for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) and accreditation and certification bodies interested in participating in the Accredited Third-Party C

For Immediate Release: May 28, 2021 Today, the U.S. Food and Drug Administration approved Lumakras (sotorasib) as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation called KRAS G12C and who have received at least one prior systemic therapy. This is the first approved targeted therapy for tumors with any KRAS mutation, which accounts for ap

For Immediate Release: May 21, 2021 Today, the U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The FDA also approved the Guardant360 CDx (Guardant Health Inc.) as a companion diagnostic for Ry

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8-K - Guardant Health, Inc. (0001576280) (Filer)

Collaboration enables insights from ConcertAI national database of 5.5M clinical records and Guardant profiling data across 60+ tumor types Longitudinal DNA methylation measurements and comprehensive genomic profiling allow deeper insights into intrinsic and acquired resistance mechanisms   Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, and ConcertAI, a leading oncology real-world evidence data and AI SaaS technology company, today announced a collaboration agreement that allows biopharmaceutical companies to access the first multi-modal real-world data (RWD) that integrates comprehensive patient electronic medical record (EMR) data with both genomic and e

Proposed collaboration aims to integrate cutting-edge AI and genomic insights to advance guideline-directed medical therapy Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced a proposed collaboration with Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, to address challenges in lung cancer care. The collaboration aims to help oncologists diagnose lung cancer earlier and make more informed treatment decisions to improve patient outcomes, reflecting the companies' shared commitment to leveraging technology to close critical gaps in cancer care and streamline the patient journey. "This collaboration represents a pro

Full year revenue growth of 31% driven by strong clinical and biopharma volume and Guardant360 ASP tailwinds Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced preliminary, unaudited results for the quarter and full year ended December 31, 2024. Fourth quarter 2024 preliminary unaudited financial results For the three-month period ended December 31, 2024, as compared to the same period of 2023: Total revenue of approximately $200 million, an increase of 29% Reported approximately 57,300 oncology clinical tests (excluding Shield) and approximately 11,050 biopharma tests, an increase of 24% and 16%, respectively Reported approximately 6,400

Guardant Health Shield multi-cancer detection test selected on basis of strong performance in predicting presence of cancers and cancer tissue of origin Pilot study by National Cancer Institute's Cancer Screening Research Network will inform design of future research evaluating use of multi-cancer detection blood tests to screen for cancer Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced the National Cancer Institute (NCI) has selected the company's Shield™ multi-cancer detection (MCD) test for use in its Vanguard study, which will address the feasibility of using MCD tests in future clinical trials related to cancer screening. MCD tests are bl

Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced the company will participate in the upcoming 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. Guardant Health's management is scheduled to present and participate in a Q&A session on Monday, January 13, at 4:30 p.m. Pacific Time / 7:30 p.m. Eastern Time. Interested parties may access live and archived webcasts of the sessions on the "Investors" section of the company website at: www.guardanthealth.com. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardan

Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, and Meaningful Insights Biotech Analytics (MiBA), an innovative healthcare technology company, today announced a unique partnership aimed at optimizing the use of biomarker testing and data analytics to advance precision medicine in patient care throughout the MiBA Network. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241220937037/en/ Recognizing the evolving landscape of precision medicine, the collaboration combines MiBA's cutting-edge artificial intelligence (AI) technologies and high-quality oncology data with Guardant's expertise in comprehensive tum

COTA Inc., a leader in real-world data (RWD) and analytics for oncology, announces a new partnership with leading precision oncology company Guardant Health Inc. (NASDAQ:GH) that will allow biopharmaceutical researchers to access the combined resources of COTA's research-grade electronic health record (EHR) data from academic and community care centers and Guardant's clinicogenomic testing data to accelerate the development of new cancer therapies. Using the extensive dataset and AI analytics the collaboration provides, research scientists can more easily understand and further validate correlations between molecular biomarkers, treatment decisions and clinical outcomes. They can also gai

Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced a collaboration with Boehringer Ingelheim to pursue the regulatory approval and commercialization of the Guardant360® CDx liquid biopsy as a companion diagnostic (CDx) for zongertinib, an investigational covalent tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing epidermal growth factor receptor (EGFR) in non-small cell lung cancer (NSCLC). As part of the collaboration, the Guardant360 CDx blood test will provide comprehensive genomic profiling (CGP) of tumors to identify actionable biomarkers that allow targeted therapy selection and help identify NSCLC patients with HER2 mu

Spotlight presentation using Guardant Reveal™ test suggests ctDNA has potential to predict sensitivity to endocrine therapy and long-term outcomes in HR+ breast cancer Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced the company and its research collaborators will present data demonstrating the benefits of its precision oncology tests, real-world clinical-genomic database and AI analytics in optimizing therapy selection, identifying resistance mutations, and predicting long-term outcomes at the San Antonio Breast Cancer Symposium (SABCS) 2024 in San Antonio, Texas, Dec. 10-13, 2024. Guardant and its research partners will present eight posters, in

Guardant Health Secures One of the Largest False Advertising Verdicts in History, Representing a Significant Victory for Colorectal Cancer Patients Who Could Benefit from Guardant Reveal™ Natera Found to Have Willfully Misled Oncologists in an Effort to Thwart Competition PALO ALTO, Calif., Nov. 25, 2024 /PRNewswire/ -- Guardant Health, Inc. (NASDAQ:GH) ("Guardant Health"), a leading precision oncology company, today announced that a jury in the U.S. District Court for the Northern District of California (the "Court") unanimously found in favor of Guardant Health on all of its claims from its May 2021 lawsuit against Natera, Inc. (NASDAQ:NTRA) ("Natera") for false advertising and unfair comp

Revenue growth of 34% driven by strong clinical and biopharma volume and Guardant360 ASP tailwinds Shield received favorable Medicare pricing of $920 Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today reported financial results for the quarter ended September 30, 2024. Third Quarter 2024 Financial Highlights Recorded revenue of $191.5 million for the third quarter of 2024, an increase of 34% over the third quarter of 2023 Reported 53,100 clinical tests (excluding Shield) and 10,500 biopharma tests in the third quarter of 2024, representing increases of 21% and 40%, respectively, over the third quarter of 2023 Achieved Guardant360 ASP of over $3,000 Rai

Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced it will report financial results for the third quarter 2024 after market close on Wednesday, November 6, 2024. Company management will webcast a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. Live audio of the webcast will be available on the "Investors" section of the company website at: www.guardanthealth.com. The webcast will be archived and available for replay after the event. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, G

Revenue growth of 29% driven by strong clinical and biopharma volume and Guardant360 ASP tailwinds Shield approved by FDA as primary option for CRC screening and is commercially available in U.S. Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today reported financial results for the quarter ended June 30, 2024. Second Quarter 2024 Financial Highlights Revenue of $177.2 million for the second quarter of 2024, an increase of 29% over the second quarter of 2023 Reported 49,400 tests to clinical customers and 10,475 tests to biopharmaceutical customers in the second quarter of 2024, representing increases of 14% and 56%, respectively, over the second quarte

Shield is first blood test approved by FDA as a primary screening option for colorectal cancer and that meets performance requirements for Medicare coverage Blood test offers easy, convenient and pleasant screening option with potential for improving colorectal cancer screening rates Guardant Health to host investor conference call and webcast Monday, July 29, at 8:30 a.m. ET / 5:30 a.m. PT Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced the U.S. Food and Drug Administration (FDA) has approved the company's Shield™ blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease. It is the

Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced it will report financial results for the second quarter 2024 after market close on Wednesday, August 7, 2024. Company management will webcast a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. Live audio of the webcast will be available on the "Investors" section of the company website at: www.guardanthealth.com. The webcast will be archived and available for replay after the event. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012,

Revenue growth of 31% driven by strong clinical and biopharma volume and Guardant360 ASP tailwinds Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today reported financial results for the quarter ended March 31, 2024. First Quarter 2024 Financial Highlights Revenue of $168.5 million for the first quarter of 2024, an increase of 31% over the first quarter of 2023 Reported 46,900 tests to clinical customers and 8,450 tests to biopharmaceutical customers in the first quarter of 2024, representing increases of 20% and 37%, respectively, over the first quarter of 2023 Reduced free cash flow to $(37.2) million in the first quarter of 2024, compared to $(82.0)

Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced it will report financial results for the first quarter 2024 after market close on Thursday, May 9, 2024. Company management will webcast a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. Live audio of the webcast will be available on the "Investors" section of the company website at: www.guardanthealth.com. The webcast will be archived and available for replay after the event. About Guardant Health Guardant Health is a leading precision medicine company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guar

Full year 2023 revenue growth of 25% driven by clinical volume growth of 39% Expects full year 2024 revenue to be in the range of $655 to $670 million Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today reported financial results for the quarter and full year ended December 31, 2023. Fourth Quarter 2023 Financial Highlights Revenue of $155.1 million for the fourth quarter of 2023, an increase of 22% over the fourth quarter of 2022 Reported 46,400 tests to clinical customers and 9,500 tests to biopharmaceutical customers in the fourth quarter of 2023, representing increases of 29% and 16%, respectively, over the fourth quarter of 2022 Full Year 2023

Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced it will report financial results for the fourth quarter and full year 2023 after market close on Thursday, February 22, 2024. Company management will webcast a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. Live audio of the webcast will be available on the "Investors" section of the company website at: www.guardanthealth.com. The webcast will be archived and available for replay after the event. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer.

Q3 revenue increased 22% year over year driven by clinical volume growth of 35% Raises 2023 revenue guidance to $553 to 556 million Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics, today reported financial results for the quarter ended September 30, 2023. Third Quarter 2023 Financial Highlights Revenue of $143.0 million for the third quarter of 2023, an increase of 22% over the third quarter of 2022 Reported 43,900 tests to clinical customers and 7,500 tests to biopharmaceutical customers in the third quarter of 2023, representing increas

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Guggenheim upgraded Guardant Health from Neutral to Buy and set a new price target of $36.00

Jefferies resumed coverage of Guardant Health with a rating of Buy and set a new price target of $32.00

Craig Hallum resumed coverage of Guardant Health with a rating of Buy and set a new price target of $28.00

Guggenheim initiated coverage of Guardant Health with a rating of Neutral

Wolfe Research initiated coverage of Guardant Health with a rating of Peer Perform

Raymond James upgraded Guardant Health from Mkt Perform to Outperform and set a new price target of $27.00

Bernstein initiated coverage of Guardant Health with a rating of Outperform and set a new price target of $34.00

Piper Sandler upgraded Guardant Health from Neutral to Overweight and set a new price target of $40.00

JP Morgan resumed coverage of Guardant Health with a rating of Overweight and set a new price target of $65.00

Citigroup upgraded Guardant Health from Neutral to Buy and set a new price target of $40.00 from $28.00 previously

Guardant Health, Inc. (NASDAQ:GH), a pioneer in precision oncology, today announced the appointment of Roberto A. Mignone to its board of directors, effective immediately. Mr. Mignone is the Founder and Managing Partner of Bridger Management LLC, an investment management firm founded in 2000 and specializing in long-term equity strategies. "We are fortunate to welcome Roberto Mignone to our board of directors, bringing his healthcare industry expertise, long-term vision, and business acumen to our company," said Helmy Eltoukhy, chairman and co-CEO of Guardant Health. "We look forward to Mr. Mignone's perspective as we strengthen our product offerings across the continuum of care, and look

Guardant Health, Inc. (NASDAQ:GH), a pioneer in precision oncology, today announced the appointment of Dr. Manuel Hidalgo Medina to its board of directors, effective immediately. Dr. Hidalgo currently serves as Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center. "Dr. Hidalgo brings a wealth of expertise and leadership in translational and clinical research, particularly in anticancer drug development," said Helmy Eltoukhy, chairman and co-CEO of Guardant Health. "His extensive experience in precision oncology and his commitment to advancing oncology care make him an invaluable addition to our board." A

Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced the addition of Terilyn Juarez Monroe as the company's chief people officer, effective immediately. In the newly-created role, Monroe will lead the human resources function, including people operations; cultural and organizational transformation; talent acquisition; and diversity and inclusion initiatives. Amelia Merrill, who previously served as senior vice president of people, is transitioning to an advisory role with the company. "Terilyn brings deep expertise in leading, transforming, and scaling the human resources function at rapidly growing companies, and we welcome her leadership as we pursu

Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, announced today the appointment of Musa Tariq to its board of directors, effective March 6. Currently the chief marketing officer for GoFundMe, the world's leading fundraising platform, Tariq is a distinguished marketing executive with experience leading global consumer brands. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230227005656/en/Musa Tariq, Chief Marketing Officer of GoFundMe, is joining the Guardant Health board of directors. (Photo: Business Wire) "We are very pleased to welcome Musa Tariq to our board of directors," said Helmy Eltoukhy, Guardan

Analysis utilizing GuardantINFORM™ real-world evidence platform shows cumulative incidence of EGFR C797X mutation was 12.5 percent in NSCLC patients likely to progress after first-line osimertinib treatment Study demonstrates need to identify C797X-driven resistance and tailor therapy options appropriately for patients with EGFR-mutant NSCLC Guardant Health Inc. (NASDAQ:GH), a leading precision oncology company, and Blueprint Medicines Corporation (NASDAQ:BPMC) announced today they are presenting new data demonstrating that the EGFR C797X mutation is the most common resistance mechanism to osimertinib therapy for patients with advanced non-small cell lung cancer (NSCLC). The results ar

Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced the appointment of Steve E. Krognes to its board of directors. Mr. Krognes is a professional independent board member in the biotech and life science sector. He currently serves as a director at Denali Therapeutics Inc., Gritstone bio, Inc. and RLS Global AB, and previously served on the board at Corvus Pharmaceuticals, Inc. "We are very pleased to welcome Steve Krognes to our board of directors," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "With over 20 years in the biotech and life science industry, Steve brings a wealth of knowledge and expertise in financial management and corporate s

Jett and Mildenhall will bring transformative vision and wide-ranging expertise to the fast-growing digital sports platform Separately, Fanatics releases its first environmental, social and governance (ESG) report Fanatics, a leading global digital sports platform, today announced the appointment of preeminent fintech, e-commerce and marketing executives Lydia Jett and Jonathan Mildenhall to its board of directors. Jett, Managing Partner and Head of Global eCommerce and US Consumer Internet Sector Investments at SoftBank Investment Advisers (SBIA), and Mildenhall, co-founder and Executive Chairman of TwentyFirstCenturyBrand and former CMO of Airbnb, bring decades of experience advising an

Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, has appointed Myrtle Potter to serve on its Board of Directors. "We are very pleased to welcome Myrtle Potter to our Board of Directors as we continue to build and deliver on our mission of conquering cancer with data," said Helmy Eltoukhy, Guardant Health Co-CEO and Chairman of the Board. "Myrtle has extensive knowledge and experience bringing world-class therapeutics to market, and her industry expertise will be invaluable as we strive to provide patients across all stages of cancer with access to the latest advancements in precision oncology." "I am thrilled to be joining Guardant Health's Board of Directors at su

SAN MATEO, Calif., Aug. 10, 2021 /PRNewswire/ -- uLab Systems™, creator of uSmile™ clear aligners and uDesign™ treatment planning software, announced today the appointment of three new members to its Board of Directors: Robin Bienfait, AmirAli Talasaz, and Rita O'Connor. uLab Systems announced today the appointment of three new members to its Board of DirectorsRobin Bienfait, CEO for Emnovate, has more than 30 years of experience in mobility, security, business development, enterprise sales, wireless network operations, and engineering. Prior to joining Emnovate, Robin hel

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the appointment of Chris Freeman as the company’s new Chief Commercial Officer for its oncology business, effective June 8, 2021. Chris brings significant experience successfully building and managing pharmaceutical and biotechnology brands through all stages of commercialization, which will be invaluable as the company’s oncology portfolio expands to cover advanced and earlier stage cancers. “I am thrilled to welcome Chris Freeman as our new Chief Commercial Officer. Chris’s broad experience leading blockbuster products through commercialization will b