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FDA Approves Guardant360® CDx as Companion Diagnostic for Eli Lilly and Company's Inluriyo™ (imlunestrant) for Treatment of ESR1-mutated Advanced Breast Cancer

1. Guardant Health's Guardant360 CDx approved by FDA as a companion diagnostic. 2. Approval targets advanced breast cancer patients with ESR1 mutations.

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FAQ

Why Bullish?

This FDA approval enhances Guardant Health's marketability and relevance in precision oncology, similar to the impact of FDA approvals for other diagnostic firms like Exact Sciences and NantHealth, which often result in positive stock movements.

How important is it?

FDA approvals are significant milestones that can validate a company's technology and drive investor confidence, leading to increased stock price volatility.

Why Short Term?

Short-term spikes in stock price are typical following FDA approvals due to heightened investor interest, as seen with companies like Myriad Genetics after similar news.

Related Companies

PALO ALTO, Calif.--(BUSINESS WIRE)---- $GH--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Guardant360® CDx as a companion diagnostic to identify advanced breast cancer patients with ESR1 mutations who may benefit from Eli Lilly and Company's Inluriyo (imlunestrant). Guardant360 CDx was approved in conjunction with Inluriyo for the treatment of adults with estrogen receptor-positive (ER+), human.

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