1차 출처 기록
결정급탑라인 결과
Invivyd: VYD2311의 DECLARATION 3상 톱라인 데이터, 2026년 중반 발표 예정
Invivyd는 VYD2311에 대한 DECLARATION Phase 3 핵심 임상시험의 탑라인 데이터가 2026년 중반에 예상된다고 발표했습니다. 이 시험은 COVID-19 예방을 위한 VYD2311을 평가하고 있습니다. 전체 등록이 완료되었으며, Independent Data Monitoring Committee는 임신부와 수유부의 등록을 허용할 것을 권고했습니다.
핵심 사실
출처 발췌
EX-99.1 2 d118119dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Invivyd Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Recent Business Highlights and DECLARATION Clinical Trial Updates • Achieved Q4 2025 PEMGARDA ® (pemivibart) net product revenue of $17.2 million, representing 25% growth year-over-year and 31% growth quarter-over-quarter • 2025 year-end cash and cash equivalents of $226.7 million after raising over $200 million from financing transactions in 2H 2025 • Announced initiation of DECLARATION Phase 3 pivotal clinical trial of vaccine-alternative antibody VYD2311 to prevent COVID, with top-line data expected mid-2026; Fast Track designation for VYD2311 granted by FDA in December 2025 • DECLARATION trial on track with full enrollment achieved • DEC