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ZYME PDUFA Date: Ziihera (zanidatamab-hrii)

FDA decision (PDUFA) target 2026-08-25 · Zymeworks Inc. · First-line HER2-positive gastroesophageal adenocarcinoma (GEA)

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

$28.56$22.49
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)
CompanyZymeworks Inc.
Market-cap tierSmall
Cohort decision-day move (history)±3% median
ClinicalTrials.govNCT05152147 · active

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FAQ

When is the ZYME PDUFA date?
The FDA PDUFA target date for ZYME (Zymeworks Inc.) is 2026-08-25 for Ziihera (zanidatamab-hrii). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is ZYME's drug Ziihera (zanidatamab-hrii)?
Ziihera (zanidatamab-hrii) is Zymeworks Inc.'s candidate under FDA review for First-line HER2-positive gastroesophageal adenocarcinoma (GEA).
What typically happens to a small-cap stock into a PDUFA date?
Historically, small-cap names had a median decision-day move around ±3% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.