Ionis:zilganersen 的 NDA 已进入优先审评,PDUFA日期为2026年9月22日

8-K 声明 zilganersen 在亚历山大病适应症的 NDA 已获 FDA 优先审评，PDUFA 目标行动日期为 2026 年 9 月 22 日。Ionis 还与 Recordati 签订了美国以外地区开发和商业化的许可协议。这为该资产设定了下一个监管决策节点。

关键事实

申报时间: 2026年7月29日 11:31
事件: PDUFA 日期确定
方向: 中性
公司: IONSIonis
资产: zilganersen
来源: SEC 8-K
可信度: 有来源
日历: FDA 审批决定 (PDUFA) · 2026年9月22日 · 积极

来源摘录

EX-99.1 2 ef20078953_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Ionis reports second quarter 2026 financial results and highlights progress on key programs - TRYNGOLZA ® (olezarsen) demonstrating early sHTG launch momentum, underscoring multi-billion-dollar revenue potential in large patient population – - Completed enrollment in Phase 3 REVEAL trial in Angelman syndrome - - On track to achieve 2026 financial guidance - CARLSBAD, Calif., July 29, 2026 – Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) (the “Company”) today reported financial results and provided key updates for the second quarter ended June 30, 2026. “With the approval of TRYNGOLZA in late June, Ionis is bringing the first and only treatment to reduce triglycerides and acute pancreatitis to people living with severe hypertrigly

SEC 8-K