Zanidatamab 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.
JAZZ catalyst hub · ZYME catalyst hub
All upcoming FDA decision dates on the 2026 PDUFA calendar
Zanidatamab is marketed as Ziihera (zanidatamab-hrii); the events below include those tracked under the brand name. 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 3 catalyst events for this program: 0 upcoming and 3 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.
No upcoming catalyst is on our calendar for Zanidatamab; 2 FDA decisions are on record below.
On Aug 25, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Zanidatamab is under review or in development for First-line HER2-positive gastroesophageal adenocarcinoma (GEA).
Jazz Pharmaceuticals plc, Zymeworks Inc. (JAZZ, ZYME).
Yes. The FDA approved an application for Zanidatamab on Aug 25, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.