ZYME PDUFA Date: Ziihera Updated August 19, 2026 ยท next FDA decision on the calendar FDA decision (PDUFA) target Aug 25, 2026 · Zymeworks Inc. · First-line HER2-positive gastroesophageal adenocarcinoma (GEA)
Key facts FDA PDUFA target date 2026-08-25
Drug / candidate Ziihera (zanidatamab-hrii)
Indication First-line HER2-positive gastroesophageal adenocarcinoma (GEA)
Company Zymeworks Inc.
Market-cap tier Small
New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs .
See the full 2026 PDUFA calendar → All August 2026 PDUFA dates → 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? Ziihera (zanidatamab-hrii) is Zymeworks Inc.'s candidate under FDA review for First-line HER2-positive gastroesophageal adenocarcinoma (GEA).
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