Ziihera (zanidatamab-hrii) is a Jazz Pharmaceuticals plc, Zymeworks Inc. program in First-line HER2-positive gastroesophageal adenocarcinoma (GEA). The FDA approved it on Aug 25, 2026. 2 FDA decisions on record below. Every date links its source.
Indication under review: First-line HER2-positive gastroesophageal adenocarcinoma (GEA). Sponsor: Jazz Pharmaceuticals plc, Zymeworks Inc. (JAZZ, ZYME). Market-cap tier at the time we tracked it: Large. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
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