原始来源记录
重大申请已提交
Immunome 计划于 2026 年第二季度提交 varegacestat 的 NDA
该公司公布了 varegacestat 在硬纤维瘤中的 3 期 RINGSIDE 试验积极顶线结果，并表示将于 2026 年第二季度向 FDA 提交 NDA。这将下一个监管里程碑设定为 NDA 提交本身，而非 PDUFA 日期。
关键事实
- 申报时间
- 2026年3月3日 21:05
- 事件
- 申请已提交
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- ORR
- 56% vs 9%
- PFS HR
- 0.16
来源摘录
EX-99.1 2 imnm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Immunome Reports Full Year 2025 Financial Results and Provides Business Update Mar. 3, 2026 • New Drug Application submission for varegacestat in patients with desmoid tumors planned for 2Q 2026 • IM-1021 Phase 1 ongoing with initial data expected in 2026 • Three IND submissions for solid tumor-targeted ADC programs planned in 2026 • Underwritten public offering in December 2025 raised $460.5 million in gross proceeds, extending projected cash runway into 2028 BOTHELL, Wash. – Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced financial results for the full year ended December 31, 2025, and provided a business update. “Immunome