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GH PDUFA Date: Camizestrant

FDA decision (PDUFA) target 2026-12-31 · Guardant Health Inc. · Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Metastatic Breast Cancer (mBC)

GH run-up into the PDUFA (last ~120 days)

$133.22$78.6
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-12-31
Drug / candidateCamizestrant
IndicationHormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Metastatic Breast Cancer (mBC)
CompanyGuardant Health Inc.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT04964934 · Breakthrough Therapy Designation (BTD)

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FAQ

When is the GH PDUFA date?
The FDA PDUFA target date for GH (Guardant Health Inc.) is 2026-12-31 for Camizestrant. Dates are company/FDA-sourced and can slip — verify against primary filings.
What is GH's drug Camizestrant?
Camizestrant is Guardant Health Inc.'s candidate under FDA review for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Metastatic Breast Cancer (mBC).
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.