Guardant360® CDx Receives FDA Approval as First and Only Liquid Biopsy Companion Diagnostic for Amgen’s LUMAKRAS™ (sotorasib) KRASG12C Inhibitor for Use in Advanced Non-Small Cell Lung Can...
Guardant Health, Inc. (GH)
Last guardant health, inc. earnings: 2/24 04:03 pm
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Source: Business Wire
Guardant Health liquid biopsy can help identify the 13 percent of patients harboring the KRAS G12C mutation, a previously undruggable target, who may be appropriate for LUMAKRAS REDWOOD CITY, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH) announces that the U.S. Food and Drug Administration (FDA) has approved the Guardant360® CDx test as the first and only liquid biopsy companion diagnostic for tumor mutation profiling, or comprehensive genomic profiling, to identify patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who harbor the KRAS G12C mutation and may benefit from LUMAKRAS™ (sotorasib), an FDA-approved KRASG12C inhibitor developed and manufactured by Amgen.The Guardant360 CDx FDA approval was based on clinical validation data from the CodeBreaK 100 trial evaluating sotorasib in patients with locally advanced or metastatic NSCLC. Patients identified with the KRAS G12C mutation using the Guardant360 CDx demonstrated an objective respon
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News
- FDA Advisory Panel Review of Guardant Health's Shield™ Blood Test to Screen for Colorectal Cancer to Be Held on May 23 [Yahoo! Finance]Yahoo! Finance
- FDA Advisory Panel Review of Guardant Health’s Shield™ Blood Test to Screen for Colorectal Cancer to Be Held on May 23Business Wire
- Guardant Health to Report First Quarter 2024 Financial Results on May 9, 2024Business Wire
- Guardant Health, Inc. (NASDAQ: GH) had its price target lowered by analysts at The Goldman Sachs Group, Inc. from $32.00 to $28.00. They now have a "buy" rating on the stock.MarketBeat
- Guardant Health, Inc. (NASDAQ: GH) had its "neutral" rating re-affirmed by analysts at Guggenheim.MarketBeat
GH
Earnings
- 2/22/24 - Beat
GH
Sec Filings
- 4/16/24 - Form 4
- 4/16/24 - Form 4
- 4/16/24 - Form 4
- GH's page on the SEC website