PALO ALTO, Calif. - Trading of Guardant Health , Inc.'s (NASDAQ:GH) stock was temporarily halted on Thursday as a U.S. Food and Drug Administration (FDA) advisory panel convened to examine the company's premarket approval application for its colorectal cancer screening test, ShieldTM.
The Molecular and Clinical Genetics Panel of the FDA's Medical Devices Advisory Committee, which provides independent expert advice to the agency, is reviewing the blood test designed for colorectal cancer screening in average-risk adults. The meeting, which began at 9:30 a.m. ET, is part of the FDA's process to consider Guardant Health's application for ShieldTM.
Guardant Health, founded in 2012, specializes in precision oncology, offering blood and tissue tests that deliver insights into the mechanisms of disease. Their tests are used to improve patient outcomes at various stages, including early cancer detection, monitoring for recurrence, and guiding treatment decisions for advanced cancer.
The FDA advisory committees play a crucial role in the regulatory process, offering non-binding recommendations based on scientific evidence, which the FDA may consider when making final decisions on medical products.
The temporary trading halt is a standard procedure during significant regulatory events that could impact a company's stock price. The outcome of the FDA panel's review has the potential to influence the future of Guardant Health's product offerings and market position.
The information for this report is based on a press release statement from Guardant Health, Inc.
InvestingPro Insights
As Guardant Health, Inc. (NASDAQ:GH) awaits the FDA panel's decision on its colorectal cancer screening test, ShieldTM, investors are closely monitoring the company's financial health and stock performance. Guardant Health's market cap stands at $2.75 billion, reflecting investor sentiment and the company's relative size in the market.
Despite the challenges, Guardant Health has been showing signs of growth, with a revenue increase of 25.21% over the last twelve months as of Q1 2024. This growth is further emphasized by a quarterly revenue growth of 30.9% in Q1 2024, showcasing the company's ability to expand its financial base in a competitive market.
Still, with a negative P/E ratio of -5.7 and an adjusted P/E ratio of -6.78 for the last twelve months as of Q1 2024, Guardant Health has yet to reach profitability. This is echoed in the InvestingPro Tip that analysts do not anticipate the company will be profitable this year.
InvestingPro Tips also highlight that Guardant Health's stock has experienced significant volatility, with a notable decline over the past week but a strong return over the last month. This could indicate a reactive market sentiment to recent events and the company's potential for a market rebound. Moreover, with liquid assets exceeding short-term obligations, the company maintains a stable financial position to meet its immediate financial responsibilities.
For investors seeking more in-depth analysis and additional InvestingPro Tips, there are 9 more tips available for Guardant Health at https://www.investing.com/pro/GH. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription and gain access to exclusive insights that could inform your investment decisions.
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