EX-99.1 2 d827060dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Positive HERIZON-GEA-01 Phase 3 Results Support Ziihera® (zanidatamab-hrii) as HER2-Targeted Agent-of-Choice and Ziihera Combination Regimens as New Standard of Care in First-Line HER2-Positive Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma Ziihera plus chemotherapy showed a clinically meaningful and statistically significant improvement in PFS versus trastuzumab and chemotherapy, and a clinically meaningful effect with a strong trend toward statistical significance for OS at the first OS interim analysis Ziihera plus the PD-1 inhibitor Tevimbra ® (tislelizumab) and chemotherapy demonstrated clinically meaningful and statistically significant improvements in OS and PFS versus trastuzumab and chemotherapy Company plans to submit a supplemental BLA for this indication in first half of 2026 For U.S. media and investors only DUBLIN, November 17, 2025 - Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced positive top-line results from the Phase 3 HERIZON-GEA-01 trial evaluating Ziihera® (zanidatamab-hrii) in combination with chemotherapy, with or without the PD-1 inhibitor Tevimbra® (tislelizumab), a…
Open exhibit ↗Current Report · Items 8.01, 9.01 · 8-K
Jazz Pharmaceuticals plc
JAZZNASDAQEQUITYCurrent
Other Events
Item 8.01. Other Events. On November 17, 2025, Jazz Pharmaceuticals plc issued a press release announcing positive top-line results from the Phase 3 HERIZON-GEA-01 trial evaluating Ziihera® (zanidatamab-hrii) in combination with chemotherapy, and with or without the checkpoint inhibitor tislelizumab, as a first-line treatment for HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma.…
Company context
global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with rare disease - often with limited or no therapeutic options. We have a diverse portfolio of medicines, including leading therapies addressing epilepsies, cancers and sleep disorders. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.