Invivyd Completes VYD2311 Trial Enrollment, PEMGARDA Sales Rise 31%
Invivyd completed enrollment in its DECLARATION trial of VYD2311, an intramuscular monoclonal antibody alternative to vaccines, and expects mid-2026 results with a pre-specified upsizing algorithm. PEMGARDA full-year net revenues reached $53.4m, up 31% sequentially and 25% YoY, and $226.7m in cash after H2 fundraising funds operations into mid-2026.
1. Trial Enrollment and Design
Invivyd has finished enrolling approximately 1,770 subjects in its triple-blind DECLARATION trial, randomizing participants across two active VYD2311 arms and one placebo arm. The study includes a pre-specified upsizing algorithm to boost statistical power by up to 30% if necessary, and early safety data reviews have supported enrollment adjustments for broader inclusion.
2. Commercial Performance
PEMGARDA net revenues climbed 31% sequentially and 25% year-over-year, totaling $53.4 million for full-year 2025. The product maintains a 77% reorder rate among accounts and reaches over 15,000 contracted GPO sites, reflecting growing adoption across hematology, oncology, rheumatology and infectious disease specialties.
3. Financial Position and Runway
Invivyd closed 2025 with $226.7 million in cash, bolstered by more than $200 million raised in the second half of the year. Management indicates this liquidity is sufficient to support operations through pivotal mid-2026 data readouts and ongoing commercialization efforts.
4. Pipeline Expansion
Beyond VYD2311, Invivyd is advancing clinical exploration in long COVID, RSV and measles, with discussions planned at upcoming regulatory advisory meetings. The appointment of physician-scientist Michael Mina as chief medical officer signals a strategic focus on broadening monoclonal antibody prophylaxis into new infectious and post-infection syndromes.