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Jazz Pharmaceuticals to Present Pivotal Phase 3 Results of Ziihera® (zanidatamab-hrii) Combinations in First-Line HER2-Positive Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma at the 2026 ASCO Gastrointestinal Cancers Symposium

1. Jazz's Ziihera shows positive results in HER2+ gastroesophageal cancer trials. 2. New data to be presented at ASCO GI recognizing its potential as standard care. 3. Breakthrough Therapy designation supports Ziihera’s development in biliary tract cancer. 4. Significant improvements in survival rates demonstrated over existing treatments. 5. Investor webcast scheduled to discuss research findings and future prospects.

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FAQ

Why Bullish?

The strong clinical data boosts investor confidence, reminiscent of successful biotech trials like Amgen's in cancer therapies that led to stock price spikes.

How important is it?

Recent advancements in Ziihera's clinical results increase its marketability, likely affecting JAZZ's stock performance favorably.

Why Long Term?

Positive trial results may translate into increased sales and market share over time, similar to prior oncology product successes that sustained long-term growth.

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Jazz Pharmaceuticals to Present Pivotal Phase 3 Results of Ziihera® at 2026 ASCO Gastrointestinal Cancers Symposium

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) has announced that important data regarding Ziihera® (zanidatamab-hrii) will be presented at the ASCO Gastrointestinal Cancers Symposium, set for January 8-10, 2026, in San Francisco. The company will provide updates on two key studies targeting first-line HER2-positive gastroesophageal adenocarcinoma (GEA) and previously treated biliary tract cancer (BTC).

Details of the Presentations

The Phase 3 HERIZON-GEA-01 trial results, featuring Ziihera in combination with chemotherapy, have been accepted as a late-breaking presentation. This research is particularly important for treating HER2-positive locally advanced or metastatic GEA, where there are limited treatment options and a poor prognosis. Additionally, a post-hoc analysis from the HERIZON-BTC-01 trial will discuss overall survival rates for patients with previously treated HER2-positive BTC.

Expert Insights and Expectations

Rob Iannone, M.D., M.S.C.E., Executive Vice President and Chief Medical Officer at Jazz Pharmaceuticals, expressed optimism regarding the findings. He emphasized, “We believe these positive results support Ziihera as the HER2-targeted agent-of-choice, establishing a new standard of care for HER2+ first-line metastatic GEA.”

This combination treatment, assessed alongside chemotherapy and immunotherapy, indicates a significant improvement in progression-free survival (PFS), a critical measure for evaluating first-line therapies.

Investor Webcast Scheduled

Jazz Pharmaceuticals will conduct an investor webcast on Friday, January 9, at 6:30 a.m. PT/9:30 a.m. ET to review the presented data. The webcast will include insights from senior management and Dr. Geoffrey Ku from Memorial Sloan Kettering Cancer Center. Access to the webcast will be available through the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.

Participants are encouraged to register at least 15 minutes in advance to ensure a smooth connection. A replay will be accessible via the website thereafter.

Understanding Gastroesophageal and Biliary Tract Cancers

Gastroesophageal adenocarcinoma is the fifth most common cancer worldwide, with around 20% of these patients testing positive for HER2 status. Unfortunately, the prognosis remains dire, with a five-year survival rate under 30% for gastric cancer and about 19% for GEA.

Biliary tract cancer, although rare, presents a similar challenge, characterized by late-stage diagnoses that limit treatment options primarily to chemotherapy. Approximately 12,000 new cases of HER2-positive BTC arise annually across the U.S., Europe, and Japan, highlighting the urgent need for effective therapies like Ziihera.

About Ziihera® (zanidatamab-hrii)

Ziihera is a bispecific HER2-directed antibody that engages two extracellular sites on the HER2 receptor, inducing a reduction in HER2 expression on tumor cells and triggering multiple cytotoxic mechanisms. This novel approach aims to inhibit tumor growth and improve outcomes in patients battling aggressive cancers.

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