Invivyd: FDA menyetujui IND untuk VYD2311; uji coba pivotal dimulai akhir 2025, data topline pertengahan 2026

FDA menyetujui IND dan menyelaraskan program pivotal REVOLUTION untuk VYD2311. Dua uji coba Fase 3 (DECLARATION 1.770 pasien; LIBERTY 210 pasien) direncanakan dimulai sekitar akhir tahun 2025, dengan data topline diharapkan pertengahan 2026.

Fakta utama

Diajukan: 6 Nov 2025, 12.10
Peristiwa: Perubahan registri uji klinis
Arah: Positif
Perusahaan: IVVDInvivyd
Aset: VYD2311
Sumber: SEC 8-K
Keyakinan: Bersumber

Kutipan sumber

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

SEC 8-K