1차 출처 기록
중대임상시험 등록 변경
Invivyd: FDA, VYD2311 IND 승인; 주요 시험 YE25 시작, topline 2026년 중반
FDA가 IND를 승인하고 VYD2311에 대한 REVOLUTION 주요 프로그램에 대해 합의했습니다. 두 개의 Phase 3 시험(DECLARATION 1,770명; LIBERTY 210명)이 2025년 말경 시작될 예정이며, topline 데이터는 2026년 중반에 예상됩니다.
핵심 사실
출처 발췌
EX-99.1 2 d81968dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Invivyd Reports Third Quarter 2025 Financial Results and Recent Business Highlights • PEMGARDA ® (pemivibart) net product revenue of $13.1 million reported for Q3 2025, representing 41% growth year-over-year and 11% growth quarter-over-quarter • October 2025 ending cash and cash equivalents of over $100 million; ended Q3 2025 with $85.0 million in cash and cash equivalents after closing of $57.5 million public offering in August 2025, with additional $29.8 million gross proceeds from usage of at-the-market (ATM) offering facility in October 2025 • Announced U.S. IND clearance and alignment with U.S. FDA on pivotal clinical program for VYD2311, a vaccine-alternative antibody to prevent COVID • REVOLUTION, Invivyd’s developme