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Guardant Health, Inc. (symbol: GH) is a pioneering biotechnology company headquartered in Redwood City, California. The company specializes in liquid-based cancer tests, providing innovative diagnostic tools for both clinical and research purposes. Guardant Health is renowned for its comprehensive liquid biopsy solutions, which offer non-invasive methods to access and sequence tumor DNA.
The company's flagship products include:
- Guardant360 LDT: A liquid biopsy test that assists in treatment selection for advanced-stage cancer patients.
- Guardant360 CDx: An FDA-approved companion diagnostic for several targeted therapies, ensuring precise treatment plans.
- Guardant OMNI: A broad gene panel designed for immuno-oncology research, aiding in the understanding of cancer's genetic underpinnings.
- Reveal: Launched in 2021, this tumor-agnostic molecular residual disease (MRD) test helps monitor cancer recurrence or residual disease at the molecular level.
- Shield: Introduced in 2022, this lab-developed test offers a non-invasive screening option for colorectal cancer (CRC).
Guardant Health's cutting-edge technologies have been widely adopted by thousands of oncologists globally, benefiting tens of thousands of advanced cancer patients. The company has made significant strides in early cancer detection, with ongoing projects that promise to deliver profound impacts on patient care.
Financially, Guardant Health has raised over $500 million from prestigious investors such as Sequoia Capital, Khosla Ventures, Orbimed, and SoftBank. This substantial backing underscores the confidence in Guardant's potential to revolutionize cancer diagnostics and treatment.
In addition to its product offerings, Guardant Health provides research development services, including regulatory approval consultancy and clinical trial referrals. These services are designed to support the seamless integration of their diagnostic tools into clinical practice and research settings.
Stay updated with the latest news and developments about Guardant Health, Inc. as the company continues to push the boundaries of cancer diagnostics and treatment.
Guardant Health (Nasdaq: GH) and Meaningful Insights Biotech Analytics (MiBA) have announced a strategic partnership to enhance precision oncology through biomarker testing and data analytics. The collaboration combines MiBA's AI technologies and oncology data with Guardant's expertise in tumor profiling and circulating tumor DNA monitoring.
The partnership aims to transform cancer care by implementing personalized, data-driven approaches that improve access to innovative treatments. The initiative will provide healthcare stakeholders with knowledge about biomarker testing, cancer recurrence monitoring tools, and data insights throughout the care continuum, ultimately improving cancer patient care standards.
COTA and Guardant Health (Nasdaq: GH) announced a partnership to combine their oncology data resources for advancing precision cancer therapy development. The collaboration merges COTA's research-grade EHR data from academic and community care centers with Guardant's clinicogenomic testing data.
This partnership aims to help researchers better understand correlations between molecular biomarkers, treatments, and clinical outcomes. The combined dataset and AI analytics will support more efficient drug development, particularly given that 97% of cancer clinical trials fail and development can take up to fifteen years.
The collaboration expands COTA's data breadth into solid tumors, focusing on lung, breast, and colorectal cancers. Guardant's data covers all disease stages, from initial tumor profiling to therapy monitoring, while COTA's data tracks complete cancer care journeys.
Guardant Health (Nasdaq: GH) announced a collaboration with Boehringer Ingelheim to develop the Guardant360® CDx liquid biopsy as a companion diagnostic for zongertinib, an investigational treatment for non-small cell lung cancer (NSCLC). The blood test will identify NSCLC patients with HER2 mutations who may benefit from zongertinib treatment.
According to Guardant Health's chairman, approximately 40,000 people worldwide are diagnosed annually with NSCLC with HER2 mutations, who often respond poorly to standard treatments. The Guardant360 CDx is already FDA-approved for comprehensive liquid biopsy in advanced solid tumors and serves as a companion diagnostic for multiple NSCLC targeted therapies and breast cancer therapy targeting ESR1 mutations.
Guardant Health (Nasdaq: GH) announced upcoming presentations at the San Antonio Breast Cancer Symposium (SABCS) 2024, showcasing research on their liquid biopsy tests and AI analytics. The company will present eight posters, including a spotlight presentation on the Guardant Reveal test, which investigates circulating tumor DNA (ctDNA) dynamics in breast cancer treatment.
The research suggests that ctDNA analysis could help predict endocrine therapy sensitivity and long-term outcomes in HR+ breast cancer. The presentations will cover various topics including molecular profiling, minimal residual disease testing, and real-world data analysis using Guardant's products such as GuardantINFORM, Guardant Infinity, Guardant360 CDx, and Guardant Reveal.
A federal court jury unanimously ruled in favor of Guardant Health in its lawsuit against Natera for false advertising and unfair competition. The jury awarded $292.5 million to Guardant Health, including $175.5 million in punitive damages, making it one of the largest false advertising verdicts in history. The case, filed in May 2021, centered on Natera's deliberate campaign to mislead cancer clinicians about Guardant Reveal™, a tissue-free minimal residual disease test for early-stage colorectal cancer. The jury rejected all of Natera's counterclaims.
Guardant Health (Nasdaq: GH) announced the approval of equity grants to new non-executive employees under its 2023 Employment Inducement Incentive Award Plan. The grants include 233,603 restricted stock units (RSUs) to 123 employees and stock options to purchase 50,349 shares to three employees. The RSUs vest annually over three years, while the stock options, priced at $28.16 per share, vest one-third after one year and monthly thereafter over 24 months. These grants were made in accordance with Nasdaq Listing Rule 5635(c)(4) as employment inducements.
Guardant Health (GH) reported strong Q3 2024 financial results with revenue of $191.5 million, marking a 34% increase year-over-year. The company performed 53,100 clinical tests and 10,500 biopharma tests, up 21% and 40% respectively. Key highlights include achieving a Guardant360 ASP over $3,000 and receiving favorable Medicare pricing of $920 for Shield. The company raised its 2024 revenue guidance to $720-725 million, representing 28-29% growth. Free cash flow improved to $(55) million from $(80) million in the prior year. Despite revenue growth, the company reported a net loss of $107.8 million for Q3 2024.
Guardant Health (Nasdaq: GH) has announced its participation in four major healthcare investor conferences in November and December. The company will attend the Guggenheim Inaugural Healthcare Innovation Conference in Boston (Nov 12), the Wolfe Healthcare Conference in New York (Nov 19), the Jefferies London Healthcare Conference (Nov 20), and the Piper Sandler Healthcare Conference in New York (Dec 3). The events will feature fireside chats, presentations, and one-on-one meetings. Live and archived webcasts will be available on the company's website investor section.
Guardant Health's blood-based colorectal cancer screening product Shield has been named to TIME's Best Inventions of 2024 list. Shield, which is the first FDA-approved and Medicare-reimbursed colorectal cancer screening blood test, was recognized among 200 extraordinary innovations. The company recently achieved significant milestones, including 500 peer-reviewed publications and over 500,000 patient tests delivered. Shield received FDA approval in July 2024 and subsequent Medicare reimbursement, marking a significant advancement in early cancer detection technology.
Guardant Health (GH) announced upcoming presentations at the American College of Gastroenterology (ACG) 2024 Annual Meeting highlighting the importance of blood-based colorectal cancer (CRC) screening. A key study of over 350,000 patients revealed that less than 50% of patients completed recommended repeat stool-based CRC screening over a four-year period. The company will also present data from the ECLIPSE study examining one-year outcomes of individuals tested with their Shield™ blood test, showing no difference in non-colorectal malignancy rates between positive and negative test results.
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