PDUFAApproval decision

Ziihera® (zanidatamab-hrii) + chemo

HER2-positive gastroesophageal adenocarcinoma (GEA)

JAZZJazz Pharmaceuticals

Expected catalystAugust 25, 2026Company guidance: Aug 25, 2026

Catalyst overview

Event details

Drug or asset: Ziihera® (zanidatamab-hrii) + chemo
Development stage: PDUFA
Event type: Approval decision
Indication: HER2-positive gastroesophageal adenocarcinoma (GEA)

Research signalsHigh management interest

Research summary

What is being tracked?

This catalyst tracks a PDUFA approval decision for Ziihera® (zanidatamab-hrii) + chemo in HER2-positive gastroesophageal adenocarcinoma (GEA). The expected timing is based on the latest available company guidance and may change.

Development notes

HERIZON-GEA-01 trial. With Zymeworks. 10/16/23- Presentation at ESMO 2023. 9/16/24- New and Updated Ph2 data at ESMO. 11/17/25- Positive topline results reported. Submit sBLA in H1 2026. 03/18/26:- Supplemental biologics license application submitted for 1L HER2+ GEA; AACR-ADOPT-GEA poster April 21, 2026. 04/21/26:- HERIZON-GEA-01 PD-L1 subgroup rapid oral June 1, 2026; GI AE posters May 30. 04/27/26:- FDA accepted sBLA; priority review granted. PDUFA action date August 25, 2026.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

What is being tracked?