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ONC PDUFA Date: Ziihera (zanidatamab-hrii)

FDA decision (PDUFA) target 2026-08-25 · BeOne Medicines Ltd. · First-line HER2-positive gastroesophageal adenocarcinoma (GEA)

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

$370.64$260.27
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-08-25
Drug / candidateZiihera (zanidatamab-hrii)
IndicationFirst-line HER2-positive gastroesophageal adenocarcinoma (GEA)
CompanyBeOne Medicines Ltd.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT05152147 · active

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FAQ

When is the ONC PDUFA date?
The FDA PDUFA target date for ONC (BeOne Medicines Ltd.) is 2026-08-25 for Ziihera (zanidatamab-hrii). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is ONC's drug Ziihera (zanidatamab-hrii)?
Ziihera (zanidatamab-hrii) is BeOne Medicines Ltd.'s candidate under FDA review for First-line HER2-positive gastroesophageal adenocarcinoma (GEA).
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.