HER2-positive gastroesophageal adenocarcinoma (GEA)
JAZZJazz PharmaceuticalsCatalyst overview
Research summary
This catalyst tracks a Approved update 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.
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. 08/25/26:- FDA approved Ziihera plus Tevimbra and chemo, plus Ziihera plus chemo, for 1L HER2+ GEA.
Verification
Confirm timing and program details against the company announcement or filing.