原始来源记录
重大临床试验登记变更
Invivyd：FDA批准VYD2311的IND申请；关键试验将于2025年底启动，顶线数据预计2026年年中
FDA已批准IND申请，并就VYD2311的REVOLUTION关键项目达成一致。两项3期试验（DECLARATION 1,770名患者；LIBERTY 210名患者）计划于2025年底左右启动，顶线数据预计2026年年中。
关键事实
来源摘录
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