一次情報の記録
重要試験登録の変更
Invivyd: FDA、VYD2311のINDを承認; ピボタル試験は25年末開始、トップラインは26年半ば
FDAはINDを承認し、VYD2311のREVOLUTIONピボタルプログラムについて合意した。2つの第3相試験（DECLARATION 1,770名; LIBERTY 210名）は2025年末頃に開始予定で、トップラインデータは2026年半ばに予定されている。
主要事実
出典の抜粋
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