原始出處紀錄
重大申請已送件
Immunome 計劃在 2026 年第 2 季提交 varegacestat 的 NDA
該公司宣布 varegacestat 在 desmoid tumors 的 Phase 3 RINGSIDE 頂線結果正面，並表示將在 2026 年第 2 季向 FDA 提交 NDA。這將下一個監管里程碑設定為 NDA 提交本身，而非 PDUFA 日期。
關鍵事實
- 申報時間
- 2026年3月3日 下午09:05
- 事件
- 申請已送件
- 方向
- 正面
- 來源
- SEC 8-K
- 可信度
- 有出處
- ORR
- 56% vs 9%
- PFS HR
- 0.16
來源摘錄
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