Guardant Health, Inc. - GH STOCK NEWS

Guardant Health has received FDA approval for its Guardant360 CDx test, enabling tumor mutation profiling in patients with any solid malignant neoplasm. This test also serves as a companion diagnostic for non-small cell lung cancer patients with EGFR alterations, guiding treatment with Tagrisso. The approval is backed by data from over 5,000 samples, showing that patients identified via Guardant360 CDx have progression-free survival rates comparable to those from traditional methods. With over 150,000 tests performed and broad insurance coverage, this milestone enhances personalized cancer treatment.

Guardant Health reported Q2 2020 revenue of $66.3 million, up 23% year-over-year, driven by precision oncology revenue growth of 21% to $51.0 million. Development services revenue rose 29% to $15.3 million. The company conducted 13,694 clinical tests and 2,805 biopharmaceutical tests, marking a 15% increase and a 47% decrease, respectively. Guardant's gross profit increased to $43.9 million with a 66% gross margin. However, operating expenses surged 88% to $98.5 million, resulting in a net loss of $54.6 million, up from $11.6 million the previous year.

Guardant Health has partnered with Radius Health to seek regulatory approval for Guardant360^® as a companion diagnostic for elacestrant, a treatment for advanced ER-positive, HER2-negative breast cancer resistant to CDK4/6 inhibitors. The ongoing EMERALD phase III trial is assessing elacestrant's efficacy compared to standard endocrine therapy, particularly in patients with ESR1 mutations identified by the Guardant360 test. This collaboration enhances the utility of Guardant360 in guiding treatment decisions and addresses the growing demand for liquid biopsy solutions in oncology.

Guardant Health (Nasdaq: GH) will announce its Q2 2020 financial results on August 6, 2020, following market close. A conference call will be held at 1:30 PM PT to discuss these results, accessible via the company’s website. Guardant Health is recognized for its innovative blood tests and advanced analytics aimed at improving cancer patient outcomes and reducing healthcare costs. The company has developed tests like Guardant360 and GuardantOMNI® to support advanced cancer care and is evolving its LUNAR program for early-stage cancer detection.

Guardant Health (Nasdaq: GH) announced a collaboration with Janssen Biotech to obtain regulatory approval for the Guardant360 CDx as a companion diagnostic for amivantamab, targeting non-small cell lung cancer (NSCLC) treatment in the U.S., Canada, Japan, and Europe. Guardant360, a liquid biopsy test, analyzes 74 genes to enhance genotyping rates and personalized therapy for cancer patients. The test is already covered by Medicare for most advanced solid tumors, aiding in treatment decisions.

Guardant Health, a precision oncology company, launched the GuardantINFORM platform to enhance cancer drug development. This platform integrates clinical-genomic data from over 100,000 liquid biopsy tests, aiming to provide insights into tumor evolution and treatment resistance. Key applications include targeted drug development, clinical trial optimization, and post-marketing studies. The platform presents a significant opportunity for researchers in precision oncology, focusing on advanced solid tumors. However, Guardant Health warns that the platform's future potential is subject to various risks and uncertainties.

Guardant Health (Nasdaq: GH) presented new data at the AACR Virtual Annual Meeting II, demonstrating that its LUNAR-2 liquid biopsy achieves 90% sensitivity and 94% specificity in detecting early-stage colorectal cancer (CRC). Further analysis showed a specificity of 99% among controls negative for CRC by colonoscopy. These results highlight the potential of LUNAR-2 to enhance cancer screening rates, especially amid COVID-19 challenges. The assay is currently under evaluation in the ECLIPSE trial for average-risk adults.

Guardant Health (Nasdaq: GH) has appointed Vijaya Gadde to its Board of Directors, enhancing its leadership team. Gadde, currently Chief Legal Officer at Twitter, brings extensive experience in public policy and technology management. President AmirAli Talasaz emphasized her potential to guide the company's growth in precision oncology. Gadde expressed enthusiasm for contributing to Guardant's mission of improving cancer care through innovative data solutions, particularly in advanced cancer and early detection.

Guardant Health, a precision oncology company, announced the completion of a public offering of 13,225,000 shares of common stock at $84.00 per share, raising approximately $362.3 million in gross proceeds. Of these shares, 4,312,500 were sold by Guardant Health, while 8,912,500 were sold by SoftBank Investment Advisers. The net proceeds will primarily support corporate purposes, including working capital, sales, marketing, and capital expenditures. J.P. Morgan acted as the sole book-running manager for this offering.