Guardant Health Stock Hits 52-Week High on Key FDA Approval
The regulator cleared Guardant's liquid biopsy as a companion diagnostic for a Pfizer colorectal cancer therapy, cementing a critical link between the test and treatment.
Shares of Guardant Health Inc. (NASDAQ: GH) climbed to a new 52-week high on Thursday after the company secured a pivotal U.S. Food and Drug Administration (FDA) approval for its flagship liquid biopsy test.
The precision oncology firm announced that its Guardant360® CDx test was approved as a companion diagnostic for a targeted cancer therapy from Pfizer. The approval allows doctors to use the simple blood test to identify patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) who are eligible for treatment with BRAFTOVI® (encorafenib) combined with cetuximab.
In afternoon trading, Guardant's stock reached $115.75, its highest point in the past year, pushing the company's market capitalization towards $15 billion. The approval provides a significant clinical and commercial catalyst, meeting bullish expectations from Wall Street that have built over the past month.
This regulatory milestone is critical because it formally links Guardant's diagnostic test to a specific, high-value drug regimen from a pharmaceutical giant. The designation as a 'companion diagnostic' means the test is now an essential step for patients to gain access to the BRAFTOVI combination, directly embedding Guardant360 CDx into the treatment pathway for this specific cancer subtype. This is expected to accelerate adoption of the test and create a durable revenue stream.
According to the company's official announcement, the approval was based on results from Pfizer’s Phase 3 BREAKWATER trial. The study demonstrated that the encorafenib-based treatment led to improved outcomes for patients with this specific genetic mutation, validating the clinical utility of using Guardant's test to guide therapy.
BRAF V600E mutations occur in approximately 10-15% of patients with metastatic colorectal cancer and are associated with a poorer prognosis. Guardant's non-invasive liquid biopsy offers a significant advantage over traditional tissue biopsies, which can be difficult, painful, and sometimes impossible to obtain from metastatic tumors. A blood draw provides a faster and more comprehensive way to assess the tumor's genomic profile and guide oncologists to the most effective treatment.
The approval reinforces Guardant Health’s leadership position in the burgeoning field of liquid biopsy, which aims to transform cancer care through blood-based diagnostics. The company's technology is designed to provide early cancer detection and ongoing monitoring to help optimize treatment throughout a patient's journey.
The news comes amid a period of positive momentum for the company. Earlier in January, analysts at Jefferies reiterated a "Buy" rating and raised their price target on the stock to $130, citing a strong growth outlook. Similarly, BTIG named Guardant Health a top pick for 2026, pointing to a series of potential growth catalysts, including expanded approvals and new product launches.
This latest FDA decision solidifies a key part of that growth thesis, demonstrating the company's ability to execute on its strategy of forging partnerships with pharmaceutical companies to establish its tests as the standard of care in precision oncology.