Zymeworks Inc.
PDUFA Confirmed
zanidatamab
HER2-positive unresectable locally advanced or metastatic gastroesophageal adenocarcinoma (GEA)
Countdown
50days
FDA decision Β· Aug 25, 2026
What's at stake The FDA's approval decision on zanidatamab for HER2-positive unresectable locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) is due Aug 25, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
β€œPDUFA target action date of August 25, 2026”

Provenance

1 source on file.

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