1차 출처 기록
중대신청 제출
Immunome, varegacestat에 대한 NDA 제출을 2026년 2분기에 계획
회사는 desmoid 종양에 대한 varegacestat의 긍정적인 Phase 3 RINGSIDE 톱라인 결과를 발표했으며, 2026년 2분기에 FDA에 NDA를 제출할 것이라고 밝혔습니다. 이는 다음 규제 이정표가 PDUFA 날짜가 아닌 NDA 제출 자체임을 의미합니다.
핵심 사실
출처 발췌
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