原始出處紀錄
重大臨床試驗登錄異動
Stoke 加速 EMPEROR 第三期收案及 zorevunersen 數據揭曉
該公司現預計於 2026 年第二季完成 150 名患者的收案，將 EMPEROR 第三期數據揭曉提前至 2027 年年中。計畫於 2027 年上半年啟動滾動式 NDA 提交。持續在突破性療法認定下與 FDA 討論，探索加速途徑。
關鍵事實
- 申報時間
- 2026年1月12日 下午12:34
- 事件
- 臨床試驗登錄異動
- 方向
- 正面
- 來源
- SEC 8-K
- 可信度
- 有出處
- 現金部位
- 3.917 億美元
- 註冊目標
- 150 名患者
來源摘錄
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