Jazz Pharmaceuticals plc
PDUFA Confirmed
zanidatamab
HER2+ 1L gastroesophageal adenocarcinoma
Countdown
50days
FDA decision · Aug 25, 2026
What's at stake The FDA's approval decision on zanidatamab for HER2+ 1L gastroesophageal adenocarcinoma is due Aug 25, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
“Zanidatamab sBLA submission for 1L GEA in 1H26”

Provenance

2 sources on file.

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