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JAZZ Secures FDA Nod for Expanded Use of Ziihera in Gastric Cancer
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Key Takeaways
Jazz Pharmaceuticals' Ziihera gains FDA approval for first-line HER2-positive advanced GEA treatment.
Ziihera can be used with chemotherapy, with or without Tevimbra, regardless of PD-L1 status.
Ziihera-based regimens cut progression or death risk by 35% and death risk by 28% versus standard care.
Jazz Pharmaceuticals (JAZZ - Free Report) announced that the FDA has approved a label expansion of its marketed drug, Ziihera (zanidatamab-hrii), for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA).
With the latest nod, Ziihera becomes the first bispecific HER2-targeted antibody approved in combination with a PD-1 inhibitor and chemotherapy for first-line treatment of HER2-positive advanced GEA, regardless of PD-L1 status, establishing a new standard of care.
Under the expanded indication, Ziihera can be used in combination with chemotherapy, with or without BeOne Medicines’ Tevimbra (tislelizumab-jsmr), 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.
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.
Year to date, JAZZ’s shares have increased 53.1% compared with the industry’s 10.7% growth.
Image Source: Zacks Investment Research
JAZZ’s HERIZON-GEA-01 Study Data Supports Approval in GEA
The FDA approval for Ziihera in GEA was supported by data from the phase III HERIZON-GEA-01 study. It demonstrated that Ziihera-based regimens reduced the risk of disease progression or death by 35%, as well as the risk of death by 28% when compared with trastuzumab plus chemotherapy, the current standard of care.
Ziihera was added to JAZZ’s portfolio as part of a licensing agreement with Zymeworks (ZYME - Free Report) , signed in 2022. 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 (mBC).
Ziihera is being evaluated across multiple clinical studies for the treatment of HER2-positive solid tumors.
Overall, the FDA’s latest approval marks an important expansion for Ziihera, moving the drug from a more limited BTC opportunity into a substantially larger HER2-positive GEA market and positioning it as a potential new first-line treatment option in advanced disease.
JAZZ's Zacks Rank & Stocks to Consider
Jazz Pharmaceuticals currently carries a Zacks Rank #3 (Hold).
Over the past 30 days, earnings per share estimates for Amneal Pharmaceuticals have increased from $1.00 to $1.02 for 2026. Over the same period, estimates for earnings per share increased from $1.12 to $1.21 for 2027. AMRX shares have risen 42.2% year to date.
Amneal Pharmaceuticals beat earnings in each of the trailing four quarters, delivering an average surprise of 32.82%.
Over the past 30 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have declined 7% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
View the Zacks #1 Rank List
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JAZZ Secures FDA Nod for Expanded Use of Ziihera in Gastric Cancer
Key Takeaways
Jazz Pharmaceuticals (JAZZ - Free Report) announced that the FDA has approved a label expansion of its marketed drug, Ziihera (zanidatamab-hrii), for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA).
With the latest nod, Ziihera becomes the first bispecific HER2-targeted antibody approved in combination with a PD-1 inhibitor and chemotherapy for first-line treatment of HER2-positive advanced GEA, regardless of PD-L1 status, establishing a new standard of care.
Under the expanded indication, Ziihera can be used in combination with chemotherapy, with or without BeOne Medicines’ Tevimbra (tislelizumab-jsmr), 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.
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.
Year to date, JAZZ’s shares have increased 53.1% compared with the industry’s 10.7% growth.
Image Source: Zacks Investment Research
JAZZ’s HERIZON-GEA-01 Study Data Supports Approval in GEA
The FDA approval for Ziihera in GEA was supported by data from the phase III HERIZON-GEA-01 study. It demonstrated that Ziihera-based regimens reduced the risk of disease progression or death by 35%, as well as the risk of death by 28% when compared with trastuzumab plus chemotherapy, the current standard of care.
Ziihera was added to JAZZ’s portfolio as part of a licensing agreement with Zymeworks (ZYME - Free Report) , signed in 2022. 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 (mBC).
Ziihera is being evaluated across multiple clinical studies for the treatment of HER2-positive solid tumors.
Overall, the FDA’s latest approval marks an important expansion for Ziihera, moving the drug from a more limited BTC opportunity into a substantially larger HER2-positive GEA market and positioning it as a potential new first-line treatment option in advanced disease.
JAZZ's Zacks Rank & Stocks to Consider
Jazz Pharmaceuticals currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Amneal Pharmaceuticals (AMRX - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy) and AC Immune (ACIU - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings per share estimates for Amneal Pharmaceuticals have increased from $1.00 to $1.02 for 2026. Over the same period, estimates for earnings per share increased from $1.12 to $1.21 for 2027. AMRX shares have risen 42.2% year to date.
Amneal Pharmaceuticals beat earnings in each of the trailing four quarters, delivering an average surprise of 32.82%.
Over the past 30 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have declined 7% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.