PEMGARDA Revenue Growth
PEMGARDA net revenues grew 31% quarter-over-quarter in Q4 2025 and 25% year-over-year versus Q4 2024; full-year 2025 net revenues totaled $53.4 million.
Strong Cash Position and Fundraising
Raised over $200 million in 2025 and ended the year with $226.7 million in cash and cash equivalents, positioned to fund pivotal VYD2311 data in mid-2026 (and potentially beyond subject to commercial performance and operational discipline).
Commercial Traction and Durable Demand
High commercial engagement: 77% account reorder rate for PEMGARDA and more than 15,000 contracted GPO sites, with expanding adoption across hematology, oncology, rheumatology, infectious disease, transplant, neurology and other specialties.
Declaration Trial Enrollment Milestone
Declaration randomized, triple-blind study reached target enrollment (~1,770 subjects randomized 1:1:1:1) and has begun accruing COVID events, with event accumulation described as 'on track' to support assessment of VYD2311 effectiveness.
Positive Safety/Tolerability IDMC Recommendations
Independent Data Monitoring Committee recommended easing enrollment restrictions: pregnant and breastfeeding women may enroll, contraception no longer required for women of childbearing age, and several prespecified early post-dose safety visits (days 8, 38, 68) are no longer required — indicating a favorable initial safety/tolerability profile.
VYD2311 Profile and Clinical Strategy
VYD2311 characterized as more potent in vitro than pemivibart with a longer measured half-life and formulated for intramuscular dosing; Invivyd is running its third randomized, placebo-controlled COVID monoclonal antibody trial and anticipates mid-year (Q2–Q3 2026) pivotal data timing if upsizing is not required.
Pipeline Expansion and Targeted Indications
Pipeline broadened beyond COVID: beginning clinical exploration in long COVID and post-vaccine syndrome, identified a highly potent RSV antibody (positioned as competitive with existing standard of care), and expects an update on the measles program in H1 2026 — signaling diversified infectious-disease R&D.
Regulatory and Guideline Momentum
Increased clinical recognition for monoclonal antibody prophylaxis: PEMGARDA included in NCCN guidelines for B-cell lymphomas; ACIP scheduled discussions on long COVID/post-vaccine syndrome which could influence future receptivity to antibody approaches.