原始来源记录
决策级顶线结果
Cogent Biosciences：SUMMIT 顶线结果积极；NDA 计划于 2025 年底前推进
8-K 文件确认 bezuclastinib 在 NonAdvSM 中的 SUMMIT 试验取得积极顶线结果，所有主要终点和关键次要终点均达到统计学显著性。FDA 已就 NonAdvSM 广泛人群的 NDA 提交计划达成一致，并授予两个特定 NonAdvSM 亚群突破性疗法认定。公司重申将于 2025 年底前提交 bezuclastinib 的首份 NDA。
关键事实
- 申报时间
- 2025年11月3日 14:13
- 事件
- 顶线结果
- 方向
- 中性
- 来源
- SEC 8-K
- 可信度
- 有来源
- 日历
- FDA 审批决定 (PDUFA) · 2026年11月30日 · 积极
- ORR PPR
- 80%
- ORR mIWG
- 57%
- 胰蛋白酶降低
- 89%
- KIT D816V降低
- 91%
- 骨髓降低
- 89%
- 中位至缓解时间
- 2.0个月
来源摘录
EX-99.1 2 cogt-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2025 Financial Results Phase 3 PEAK results in 2 nd -line GIST patients expected in November; pivotal APEX results in AdvSM patients expected in December Breakthrough Therapy Designation granted for bezuclastinib; New Drug Application (NDA) filing for NonAdvSM remains on track for year-end 2025 Multiple bezuclastinib abstracts selected for presentation at the 67 th Annual Meeting of the American Society of Hematology (ASH); SUMMIT data in NonAdvSM selected for two oral presentations Plan to showcase novel JAK2 V617F mutant-selective candidate at ASH 2025 Strong pro forma cash position of $430 million expected to fund operations through anticipated launch of