Immunome 提交 NDA 申请，varegacestat 用于治疗韧带样瘤

Immunome 于 2026 年 4 月向 FDA 提交了 NDA 申请，varegacestat 用于治疗成人韧带样瘤。该申请基于 RINGSIDE 3 期试验的积极顶线数据，显示与安慰剂相比，疾病进展或死亡风险降低 84%。公司还计划在 2026 年底前向 EMA 提交 MAA 申请。

关键事实

申报时间: 2026年5月12日 20:05
事件: 申请已提交
方向: 积极
公司: IMNMImmunome
资产: varegacestat
来源: SEC 8-K
可信度: 有来源

来源摘录

EX-99.1 2 imnm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Immunome Reports First Quarter 2026 Financial Results and Provides Business Update May 12, 2026 • New Drug Application (NDA) submitted to the U.S. Food and Drug Administration (FDA) in April 2026 seeking approval of varegacestat for the treatment of adults with desmoid tumors • Detailed Phase 3 RINGSIDE data selected for oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting • Phase 1 study ongoing for IM-1021, with initial lymphoma data expected in 2026 • Investigational New Drug (IND) clearance received in April 2026 for IM-1617, a potential first-in-class solid tumor antibody-drug conjugate (ADC) BOTHELL, Wash. – Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing fi

SEC 8-K