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JAZZ Hits 52-Week High on Encouraging Gastric Cancer Study Data
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Key Takeaways
JAZZ shares surged after positive late-stage HERIZON-GEA-01 results in first-line HER2 GEA.
The study showed significant PFS gains and strong OS outcomes for Ziihera-based regimens.
JAZZ plans to seek Ziihera label expansion in 2026 following these first late-stage results.
Shares of Jazz Pharmaceuticals (JAZZ - Free Report) rose nearly 21% on Monday after it announced positive top-line results from the late-stage HERIZON-GEA-01 study. This study evaluated different combination regimens involving Ziihera (zanidatamab) as a first-line treatment for HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma (GEA).
The HERIZON-GEA-01 study evaluated two regimens — Ziihera plus chemotherapy and Ziihera combined with BeOne Medicines’ (formerly BeiGene) PD-1 inhibitor Tevimbra plus chemotherapy — against the current standard of care (SoC) treatment, trastuzumab plus chemotherapy, in the given population.
While Jazz did not disclose any numerical data supporting the results, it stated that both regimens achieved highly statistically significant and clinically meaningful improvements in progression-free survival (PFS), meeting one of the study’s dual primary endpoints.
For the other primary endpoint of overall survival (OS), Jazz shared results from the first interim analysis. It reported that the three-drug regimen achieved clinically meaningful and statistically significant improvements in OS, while the two-drug regimen showed only a clinically meaningful effect with a strong trend toward statistical significance. JAZZ intends to provide a follow-up to this OS analysis in mid-2026.
The company plans to present data from this study at a medical meeting in the first quarter of 2026.
JAZZ to Seek Label Expansion for Ziihera Next Year
Based on results from the HERIZON-GEA-01 study, Jazz intends to seek label expansion for the drug in the GEA indication in the first half of 2026.
JAZZ Stock Performance
Following the news, shares of Jazz hit a 52-week high. Per the company, these findings highlight the drug’s potential to become the new SoC for first-line HER2+ GEA — an area with significant commercial potential compared to second-line BTC.
Year to date, the stock has risen 38% compared with the industry’s 15% growth.
Image Source: Zacks Investment Research
JAZZ’s Progress With Ziihera Development
The HERIZON-GEA-01 marks the first late-stage study results for Ziihera. Apart from GEA, Jazz is also developing the drug in two late-stage studies in first-line BTC and metastatic breast cancer indications. The BTC study will also be used to convert the accelerated approval to a full one.
Jazz is also evaluating Ziihera across two mid-stage studies — the DiscovHER-Pan-206 basket study across HER2-positive solid tumors and the EmpowHER-208 study in patients with HER2+ neoadjuvant and adjuvant breast cancer.
Ziihera was added to Jazz’s portfolio as part of a licensing agreement with Zymeworks (ZYME - Free Report) , signed in 2022. Per the agreement terms, JAZZ has exclusive rights to develop and market Ziihera in all territories except Asia/Pacific (where the drug has been licensed to BeOne Medicines). Zymeworks is eligible to receive tiered royalties on sales of the drug.
EPS estimates for Alkermes’ 2025 have increased from $1.82 to $1.96, while those for 2026 have risen from $1.70 to $1.87 in the past 60 days. ALKS stock has gained 2% year to date.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average negative surprise of 4.58%.
In the past 60 days, estimates for CorMedix’s earnings per share (EPS) have increased from $1.52 to $2.90 for 2025. During the same time, EPS estimates for 2026 have increased from $2.09 to $2.72. Year to date, shares of CRMD have rallied 23%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, the average surprise being 27.04%.
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JAZZ Hits 52-Week High on Encouraging Gastric Cancer Study Data
Key Takeaways
Shares of Jazz Pharmaceuticals (JAZZ - Free Report) rose nearly 21% on Monday after it announced positive top-line results from the late-stage HERIZON-GEA-01 study. This study evaluated different combination regimens involving Ziihera (zanidatamab) as a first-line treatment for HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma (GEA).
The HERIZON-GEA-01 study evaluated two regimens — Ziihera plus chemotherapy and Ziihera combined with BeOne Medicines’ (formerly BeiGene) PD-1 inhibitor Tevimbra plus chemotherapy — against the current standard of care (SoC) treatment, trastuzumab plus chemotherapy, in the given population.
While Jazz did not disclose any numerical data supporting the results, it stated that both regimens achieved highly statistically significant and clinically meaningful improvements in progression-free survival (PFS), meeting one of the study’s dual primary endpoints.
For the other primary endpoint of overall survival (OS), Jazz shared results from the first interim analysis. It reported that the three-drug regimen achieved clinically meaningful and statistically significant improvements in OS, while the two-drug regimen showed only a clinically meaningful effect with a strong trend toward statistical significance. JAZZ intends to provide a follow-up to this OS analysis in mid-2026.
The company plans to present data from this study at a medical meeting in the first quarter of 2026.
JAZZ to Seek Label Expansion for Ziihera Next Year
Ziihera was granted accelerated approval by the FDA last year for use in previously treated adult patients with unresectable or metastatic HER2+ biliary tract cancer (BTC).
Based on results from the HERIZON-GEA-01 study, Jazz intends to seek label expansion for the drug in the GEA indication in the first half of 2026.
JAZZ Stock Performance
Following the news, shares of Jazz hit a 52-week high. Per the company, these findings highlight the drug’s potential to become the new SoC for first-line HER2+ GEA — an area with significant commercial potential compared to second-line BTC.
Year to date, the stock has risen 38% compared with the industry’s 15% growth.
Image Source: Zacks Investment Research
JAZZ’s Progress With Ziihera Development
The HERIZON-GEA-01 marks the first late-stage study results for Ziihera. Apart from GEA, Jazz is also developing the drug in two late-stage studies in first-line BTC and metastatic breast cancer indications. The BTC study will also be used to convert the accelerated approval to a full one.
Jazz is also evaluating Ziihera across two mid-stage studies — the DiscovHER-Pan-206 basket study across HER2-positive solid tumors and the EmpowHER-208 study in patients with HER2+ neoadjuvant and adjuvant breast cancer.
Ziihera was added to Jazz’s portfolio as part of a licensing agreement with Zymeworks (ZYME - Free Report) , signed in 2022. Per the agreement terms, JAZZ has exclusive rights to develop and market Ziihera in all territories except Asia/Pacific (where the drug has been licensed to BeOne Medicines). Zymeworks is eligible to receive tiered royalties on sales of the drug.
JAZZ’s Zacks Rank
Jazz currently carries a Zacks Rank #3 (Hold).
Jazz Pharmaceuticals PLC Price
Jazz Pharmaceuticals PLC price | Jazz Pharmaceuticals PLC Quote
Our Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are Alkermes (ALKS - Free Report) and CorMedix (CRMD - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
EPS estimates for Alkermes’ 2025 have increased from $1.82 to $1.96, while those for 2026 have risen from $1.70 to $1.87 in the past 60 days. ALKS stock has gained 2% year to date.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average negative surprise of 4.58%.
In the past 60 days, estimates for CorMedix’s earnings per share (EPS) have increased from $1.52 to $2.90 for 2025. During the same time, EPS estimates for 2026 have increased from $2.09 to $2.72. Year to date, shares of CRMD have rallied 23%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, the average surprise being 27.04%.