FDA Approves Guardant360® Cdx as Companion Diagnostic for Arvinas/Pfizer Breast Cancer Drug
GH has more than doubled off its 52-week low of $36.36.
Summary
Guardant Health has received FDA approval for its Guardant360® Cdx liquid biopsy as a companion diagnostic. This approval specifically targets patients with ER+/HER2- advanced breast cancer who have ESR1 mutations, for use with Arvinas and Pfizer's drug Veppanu (Vepdegestrant). This regulatory milestone expands the clinical utility and market opportunity for Guardant Health's flagship diagnostic product, potentially driving increased adoption and revenue. It reinforces the company's position in precision oncology and provides a new revenue stream tied to a specific therapeutic.
At the time of this announcement, GH was trading at $87.10 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $11.5B. The 52-week trading range was $36.36 to $120.74. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Reuters.