Immunome 提交 desmoid 腫瘤用藥 varegacestat 的 NDA

Immunome 於 2026 年 4 月向 FDA 提交 NDA，申請核准 varegacestat 用於治療成人 desmoid 腫瘤。此項申請係基於 Phase 3 RINGSIDE 試驗正面頂線數據，顯示相較安慰劑可降低 84% 疾病進展或死亡風險。公司亦計畫於 2026 年底前向 EMA 提交 MAA。

關鍵事實

申報時間: 2026年5月12日下午08:05
事件: 申請已送件
方向: 正面
公司: IMNMImmunome
資產: varegacestat
來源: SEC 8-K
可信度: 有出處

來源摘錄

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