Jazz Pharmaceuticals plc (JAZZ) on Monday said that the U.S. Food and Drug Administration (FDA) has granted priority review to its supplemental Biologics License Application for Ziihera for the first-line treatment of adults with HER2-positive gastric, gastroesophageal junction (GEJ), or gastroesophageal adenocarcinoma (GEA).
The FDA has set a PDUFA target action date of August 25, 2026.
The application is supported by positive data from the HERIZON-GEA-01 trial, which evaluated zanidatamab in combination with standard chemotherapy, with or without Tevimbra, in patients with these cancers.
On Friday JAZZ shares closed at $196.52, down 1.72%.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.