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AZN PDUFA Date: Enhertu (trastuzumab deruxtecan)

FDA decision (PDUFA) target 2026-09-30 · AstraZeneca PLC · HER2-positive early breast cancer

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

$208.67$176.28
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-09-30
Drug / candidateEnhertu (trastuzumab deruxtecan)
IndicationHER2-positive early breast cancer
CompanyAstraZeneca PLC
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.gov—

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FAQ

When is the AZN PDUFA date?
The FDA PDUFA target date for AZN (AstraZeneca PLC) is 2026-09-30 for Enhertu (trastuzumab deruxtecan). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is AZN's drug Enhertu (trastuzumab deruxtecan)?
Enhertu (trastuzumab deruxtecan) is AstraZeneca PLC's candidate under FDA review for HER2-positive early breast cancer.
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.