FDA Approves Guardant Health's Guardant360 CDx as Companion Diagnostic for Boehringer Ingelheim's HERNEXEOS
GH has more than doubled off its 52-week low of $40.355 on light trading volume (0.2× avg).
Summary
Guardant Health secured FDA approval for its Guardant360 CDx liquid biopsy as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS, a new targeted therapy for HER2-mutant advanced non-small cell lung cancer. This approval expands the utility of Guardant Health's flagship diagnostic product, building on previous FDA approvals for Guardant360 CDx. The news also noted Eli Lilly received FDA approval for an extended dosing schedule for its atopic dermatitis drug EBGLYSS. For Guardant Health, this specific indication for a new cancer treatment directly increases the market and revenue potential for its test, solidifying its position in precision oncology.
At the time of this announcement, GH was trading at $131.11 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $17.4B. The 52-week trading range was $40.36 to $134.28. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: dpa-AFX.