Jazz：FDA为zanidatamab 1L GEA sBLA设定2026年8月25日PDUFA日期

FDA授予优先审评，并为寻求批准zanidatamab联合用药用于一线HER2+胃食管腺癌的sBLA设定了2026年8月25日的PDUFA目标行动日期。公司表示已准备好在获批后立即上市。这是该适应症中该资产的下一个监管决策节点。

关键事实

申报时间: 2026年8月3日 20:06
事件: PDUFA 日期确定
方向: 积极
公司: JAZZJazz Pharmaceuticals
资产: zanidatamab
来源: SEC 8-K
可信度: 有来源
日历: FDA 审批决定 (PDUFA) · 2026年8月25日 · 已批准

来源摘录

EX-99.1 2 a2q26financialpr.htm EX-99.1 Document Exhibit 99.1 Jazz Pharmaceuticals Announces Second Quarter 2026 Financial Results – Continued commercial execution drives record total revenues of $1.2 billion (+16% YoY) – – Company raises 2026 revenue guidance – – Prepared to launch Ziihera ® in HER2+ 1L GEA immediately following FDA approval – – Xywav ® revenues grew 13% YoY with 525 net patient adds in 2Q26 – – Epidiolex ® revenues grew 16% YoY – DUBLIN, August 3, 2026 -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the second quarter of 2026 (2Q26) and raised revenue guidance for 2026. "Our second quarter results highlight strong execution and momentum across the business, delivering 16% year-over-year total revenue growth and driving a consider

SEC 8-K