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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April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.