How FDA Approval of Guardant360 CDx for Inluriyo Has Shaped Guardant Health's (GH) Investment Story

• The U.S. FDA recently approved Guardant Health's Guardant360 CDx as a companion diagnostic for Eli Lilly's Inluriyo, expanding its use to help identify advanced breast cancer patients with specific ESR1 mutations who may benefit from this new treatment.
• This milestone marks the sixth FDA-approved indication for Guardant360 CDx and underscores Guardant Health's expanding presence in precision oncology diagnostics, particularly in breast and colorectal cancer care.
• We'll examine how this new FDA approval for Guardant360 CDx strengthens Guardant Health's investment narrative in precision oncology.

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Guardant Health Investment Narrative Recap

To own shares of Guardant Health, investors need to believe in the large and fast-growing opportunity for liquid biopsy and blood-based cancer diagnostics, and that Guardant can convert clinical adoption and regulatory wins into accelerating revenue and, eventually, a path to profitability. The FDA approval of Guardant360 CDx for Eli Lilly’s Inluriyo expands the company’s clinical utility but is unlikely to materially impact the most pressing short term catalyst: broad payer adoption and coverage for Shield, which remains central to near-term growth, or its largest risk, continuing high cash burn and net losses. Among the recent announcements, the collaboration with Quest Diagnostics stands out as most relevant. By making Shield more accessible through Quest’s extensive national network, this agreement has direct bearing on the commercial adoption catalysts that are critical to supporting market expansion and could help address some headwinds around payer coverage and clinical uptake. In contrast, investors should be aware that Guardant’s high spending levels and ongoing net losses mean that achieving sustained cash flow stability is still a challenge...

Read the full narrative on Guardant Health (it's free!)

Guardant Health's outlook anticipates $1.5 billion in revenue and $82.1 million in earnings by 2028. This scenario assumes a 22.5% annual revenue growth rate and a $495.9 million increase in earnings from the current loss of $413.8 million.

Uncover how Guardant Health's forecasts yield a $62.41 fair value, in line with its current price.

Exploring Other Perspectives

Simply Wall St Community members provided three fair value estimates for Guardant Health ranging from US$62 to US$187 per share. While some see big upside, others remain more cautious given the company’s high ongoing cash burn and reliance on hitting major payer adoption milestones.

Explore 3 other fair value estimates on Guardant Health - why the stock might be worth over 3x more than the current price!

Build Your Own Guardant Health Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Guardant Health research is our analysis highlighting 2 key rewards and 3 important warning signs that could impact your investment decision.
• Our free Guardant Health research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Guardant Health's overall financial health at a glance.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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