Zymeworks Inc., ZYME, FDA Calendar, PDUFA Date

Company Name	Zymeworks Inc. ZYME
Drug Name	Ziihera (sBLA)
Event Name	FDA decision on Ziihera combinations in First-Line HER2+ Locally Advanced or Metastatic gastroesophageal adenocarcinoma
Event Date	08/25/2026
Outcome Date
Outcome	Pending
Drug Status
Rival Drugs
Market Potential
Other Approvals	FDA granted accelerated approval to Ziihera (zanidatamab-hrii) for the Treatment of HER2-Positive Biliary Tract Cancer in 2024.
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