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JAZZ Rises on Updated OS Results From Gastric Cancer Study
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Key Takeaways
Jazz reported statistically significant, clinically meaningful OS improvement for Ziihera plus chemotherapy.
Ziihera plus Tevimbra and chemotherapy also showed improved OS hazard ratios with longer follow-up.
Ziihera's recent FDA approvals could help expand its role in first-line HER2-positive GEA.
Jazz Pharmaceuticals (JAZZ - Free Report) announced second interim top-line overall survival (OS) results from the phase III HERIZON-GEA-01 study, which evaluated different combination regimens involving its marketed drug, 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.
The second interim analysis has now demonstrated that the two-drug regimen of Ziihera plus chemotherapy led to a statistically significant and clinically meaningful improvement in OS versus trastuzumab plus chemotherapy (SoC), strengthening the clinical profile of Ziihera in first-line HER2-positive GEA. Importantly, the OS hazard ratio improved from the first interim analysis, indicating a stronger survival benefit with longer follow-up.
The latest results represent an important update to the first interim analysis. In the first interim analysis reported in November 2025, the results had only shown a strong trend toward statistical significance.
Management also reported that with longer follow-up, Ziihera plus Tevimbra and chemotherapy resulted in an improvement in the OS hazard ratio compared with the first interim analysis. Jazz said the updated findings further demonstrate a statistically significant, clinically meaningful and durable OS benefit for the three-drug regimen.
JAZZ’s Price Performance
Shares of Jazz were up 2.5% yesterday following the announcement of the updated OS results. The stock has rallied 47.5% so far this year, compared with the industry’s increase of 9.7%.
Image Source: Zacks Investment Research
JAZZ’s Recent Progress With Ziihera
The updated OS results follow the FDA’s recent label expansion of Ziihera as the first-line treatment of adults with HER2-positive unresectable locally advanced or metastatic GEA.
Under the expanded indication, Ziihera can be used in combination with chemotherapy, with or without Tevimbra, in this patient population. The approval significantly expands the addressable market for Ziihera beyond its existing use in previously treated HER2-positive biliary tract cancer (BTC).
The expanded indication represents a much larger commercial opportunity than Ziihera’s existing BTC indication.
GEA encompasses stomach, gastroesophageal junction and esophageal cancers and is the fifth most common cancer globally. Approximately 20% of GEA patients have HER2-positive disease, a subgroup associated with particularly poor outcomes in advanced and metastatic settings. In metastatic disease, the five-year survival rate remains below 10%, highlighting the need for more effective treatment options.
The latest findings could help Jazz establish Ziihera-based regimens as an important treatment option in the first-line setting and support the company's efforts to position Ziihera as the preferred HER2-targeted backbone therapy. Jazz plans to present the updated results at a medical meeting in the fourth quarter of 2026 and submit the same to regulatory authorities worldwide.
With its approval across HER2-positive disease regardless of PD-L1 status, Ziihera could address a broader patient population than regimens that require PD-L1 expression.
Ziihera was added to JAZZ’s portfolio as part of a 2022 licensing agreement with Zymeworks (ZYME - Free Report) .
Per the agreement, JAZZ has exclusive rights to develop and market Ziihera in all territories except Asia-Pacific territories (where the drug has been licensed to BeOne Medicines). Zymeworks is eligible to receive tiered royalties on sales of the drug. JAZZ is developing the drug in separate late-stage studies across first-line BTC and metastatic breast cancer.
Ziihera is being evaluated across multiple clinical studies for the treatment of HER2-positive solid tumors.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 10.5% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK’s shares have surged 117.2% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
View the Zacks #1 Rank List
Image: Bigstock
JAZZ Rises on Updated OS Results From Gastric Cancer Study
Key Takeaways
Jazz Pharmaceuticals (JAZZ - Free Report) announced second interim top-line overall survival (OS) results from the phase III HERIZON-GEA-01 study, which evaluated different combination regimens involving its marketed drug, 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.
The second interim analysis has now demonstrated that the two-drug regimen of Ziihera plus chemotherapy led to a statistically significant and clinically meaningful improvement in OS versus trastuzumab plus chemotherapy (SoC), strengthening the clinical profile of Ziihera in first-line HER2-positive GEA. Importantly, the OS hazard ratio improved from the first interim analysis, indicating a stronger survival benefit with longer follow-up.
The latest results represent an important update to the first interim analysis. In the first interim analysis reported in November 2025, the results had only shown a strong trend toward statistical significance.
Management also reported that with longer follow-up, Ziihera plus Tevimbra and chemotherapy resulted in an improvement in the OS hazard ratio compared with the first interim analysis. Jazz said the updated findings further demonstrate a statistically significant, clinically meaningful and durable OS benefit for the three-drug regimen.
JAZZ’s Price Performance
Shares of Jazz were up 2.5% yesterday following the announcement of the updated OS results. The stock has rallied 47.5% so far this year, compared with the industry’s increase of 9.7%.
Image Source: Zacks Investment Research
JAZZ’s Recent Progress With Ziihera
The updated OS results follow the FDA’s recent label expansion of Ziihera as the first-line treatment of adults with HER2-positive unresectable locally advanced or metastatic GEA.
Under the expanded indication, Ziihera can be used in combination with chemotherapy, with or without Tevimbra, in this patient population. The approval significantly expands the addressable market for Ziihera beyond its existing use in previously treated HER2-positive biliary tract cancer (BTC).
The expanded indication represents a much larger commercial opportunity than Ziihera’s existing BTC indication.
GEA encompasses stomach, gastroesophageal junction and esophageal cancers and is the fifth most common cancer globally. Approximately 20% of GEA patients have HER2-positive disease, a subgroup associated with particularly poor outcomes in advanced and metastatic settings. In metastatic disease, the five-year survival rate remains below 10%, highlighting the need for more effective treatment options.
The latest findings could help Jazz establish Ziihera-based regimens as an important treatment option in the first-line setting and support the company's efforts to position Ziihera as the preferred HER2-targeted backbone therapy. Jazz plans to present the updated results at a medical meeting in the fourth quarter of 2026 and submit the same to regulatory authorities worldwide.
With its approval across HER2-positive disease regardless of PD-L1 status, Ziihera could address a broader patient population than regimens that require PD-L1 expression.
Ziihera was added to JAZZ’s portfolio as part of a 2022 licensing agreement with Zymeworks (ZYME - Free Report) .
Per the agreement, JAZZ has exclusive rights to develop and market Ziihera in all territories except Asia-Pacific territories (where the drug has been licensed to BeOne Medicines). Zymeworks is eligible to receive tiered royalties on sales of the drug. JAZZ is developing the drug in separate late-stage studies across first-line BTC and metastatic breast cancer.
Ziihera is being evaluated across multiple clinical studies for the treatment of HER2-positive solid tumors.
Jazz Pharmaceuticals PLC Price
Jazz Pharmaceuticals PLC price | Jazz Pharmaceuticals PLC Quote
JAZZ’s Zacks Rank & Stocks to Consider
Jazz currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Repligen (RGEN - Free Report) and Anika Therapeutics (ANIK - Free Report) , both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 10.5% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK’s shares have surged 117.2% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.