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PALO ALTO - Guardant Health, Inc. (NASDAQ:GH) announced Monday that the U.S. Food and Drug Administration has approved its Guardant360 CDx blood test as a companion diagnostic to identify advanced breast cancer patients with ESR1 mutations who may benefit from Eli Lilly’s Inluriyo (imlunestrant). The company, which has seen its stock surge over 162% in the past year according to InvestingPro data, continues to expand its diagnostic capabilities.
The approval allows the blood test to be used to identify patients eligible for Inluriyo, which treats adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy.
This marks the second FDA-approved indication for Guardant360 CDx in breast cancer treatment and its sixth companion diagnostic claim overall. The test previously received FDA approval as a companion diagnostic for ORSERDU (elacestrant) in 2023.
In the Phase 3 EMBER-3 trial, Inluriyo reduced the risk of progression or death by 38% versus endocrine therapy in patients with ESR1 mutations, which are present in approximately 40% of HR+, HER2- advanced breast cancers.
"This FDA approval provides another treatment for breast cancer patients with ESR1 mutations for their specific type of cancer along with expanded access to comprehensive genomic profiling with a simple blood draw," said Helmy Eltoukhy, Guardant Health chairman and co-CEO, in a press release statement.
Guardant360 CDx is broadly covered by Medicare and commercial insurers, representing over 300 million lives, according to the company. With a strong current ratio of 3.71 and liquid assets exceeding short-term obligations as reported by InvestingPro, Guardant Health maintains a solid financial position to support its expanding diagnostic services.
Breast cancer remains the second leading cause of cancer death among women in the United States. With a market capitalization of $7.49 billion and impressive revenue growth of 28.74% over the last twelve months, Guardant Health is well-positioned in this critical healthcare sector. For deeper insights into healthcare companies and their growth potential, access comprehensive analysis through InvestingPro’s exclusive research reports covering over 1,400 US stocks.
In other recent news, Guardant Health has made significant announcements during its 2025 Investor Day. The company updated its 2028 financial targets, now projecting approximately $2.2 billion in revenue, surpassing its previous target of more than $2.0 billion. This new guidance also exceeds current Street expectations of $1.7 billion, as highlighted by Mizuho, which subsequently raised its price target for Guardant Health to $70, maintaining an Outperform rating. Additionally, TD Cowen increased its price target to $72 from $63, citing an "upbeat" Investor Day presentation. Guggenheim also raised its price target to $67 due to anticipated product launches, maintaining a Buy rating. Bernstein reiterated its Outperform rating with a $60 price target following the Investor Day event. Meanwhile, JPMorgan maintained its Overweight rating on the company’s stock after the analyst day in New York. These developments indicate a positive outlook from analysts following Guardant Health’s recent updates.
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