原始来源记录
重大临床试验登记变更
Stoke 加速 EMPEROR 3 期入组及 zorevunersen 读出
该公司现预计将于 2026 年第二季度完成 150 名患者的入组，将 EMPEROR 3 期数据读出提前至 2027 年年中。滚动 NDA 提交计划于 2027 年上半年启动。突破性疗法认定下的 FDA 持续讨论仍在探索加速路径。
关键事实
- 申报时间
- 2026年1月12日 12:34
- 事件
- 临床试验登记变更
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- 现金头寸
- 3.917亿美元
- 入组目标
- 150名患者
来源摘录
EX-99.1 2 d36198dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Stoke Therapeutics Announces Updates to Timelines for the Completion of Enrollment and a Phase 3 Data Readout from the EMPEROR Study of Zorevunersen for the Treatment of Dravet Syndrome — Company now expects to complete enrollment of 150 patients in Q2 2026, with a Phase 3 data readout in mid-2027; Rolling NDA submission planned to initiate in first half 2027— — Discussions with FDA ongoing following recent multidisciplinary meeting; Company continues to explore potential for expedited development, registration and delivery of zorevunersen to patients — – Company to present at 44 th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026 — BEDFORD, Mass, January 11, 2026 – Stoke Therapeutics, Inc . (Nasdaq: STOK) is