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Invivyd (IVVD) investor relations material
Invivyd Study update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.COVID-19 Monoclonal Antibody Program and REVOLUTION Updates
VYD2311, a next-generation monoclonal antibody for COVID-19, is in the pivotal DECLARATION study, which has reached ~50% progress and accumulated enough blinded PCR-positive events to support high anticipated efficacy, with a sample size increase triggered by interim analysis for robust statistical power.
The study includes single and multi-dose arms, with topline data expected in Q3 2026 following the addition of ~500 subjects.
FDA collaboration has led to alignment on pediatric studies (DRUMMER trial), which will assess immunogenicity and safety in children 0–11 years, with efficacy extrapolated from DECLARATION and initiation planned for Q2 2026, pending DECLARATION success.
LIBERTY study protocol, comparing VYD2311, mRNA vaccine, and their combination, has been submitted to the FDA, with operational start-up underway to inform regulatory guidance for vulnerable populations.
VYD2311 is engineered for potent neutralization of contemporary COVID-19 lineages, including BA.3.2.2 (Cicada), and is administered via intramuscular injection.
COVID-19 Variant Landscape and Antibody Performance
The BA.3.2.2 (Cicada) variant is considered virologically unfit and unlikely to drive significant waves; VYD2311 shows promising neutralization against it.
The antibody platform is designed to address broad viral variation, with the potential for a single antibody to remain effective without frequent updates.
Recent independent data support VYD2311's potency against contemporary and recycled variants.
Measles Monoclonal Antibody (VMS063) Discovery and Development
VMS063 is a novel, highly potent, half-life-extended monoclonal antibody targeting a conserved epitope on the measles F protein, advancing toward IND-enabling studies with IND readiness targeted for late 2026.
VMS063 demonstrates strong in vitro neutralization across all tested measles variants and is positioned for both treatment and prevention, including post-exposure and pre-exposure settings.
U.S. measles cases have surged to a 30-year high, with over 2,200 cases in 2025 and more than 1,500 in Q1 2026; vaccine coverage among kindergartners has dropped below herd immunity threshold.
Current treatments (IVIG, vitamin A, pooled plasma immune globulin) are inadequate, with variable efficacy and limited use cases; VMS063 could fill significant unmet needs as population immunity wanes.
VMS063 aims to fill the gap for populations not covered by vaccination, including infants, pregnant women, immunocompromised, vaccine-hesitant, and other high-risk groups.
- Shareholders will elect six directors and vote on auditor ratification at the 2026 annual meeting.IVVD
Proxy filing6 Apr 2026 - Six independent directors up for election and auditor ratification headline the annual meeting.IVVD
Proxy filing6 Apr 2026 - Q4 PEMGARDA revenue up 25% YoY to $17.2M; DECLARATION trial fully enrolled for mid-2026 data.IVVD
Q4 20255 Mar 2026 - Strong early uptake of PEMGARDA supports $150–$200M revenue guidance and robust cash outlook.IVVD
Jefferies 2024 Global Healthcare Conference1 Feb 2026 - PEMGARDA launch drove $2.3M Q2 revenue, but cash runway is under one year.IVVD
Q2 20241 Feb 2026 - Pemgarda sees strong launch in immunocompromised COVID-19 prevention; next-gen antibody in trials.IVVD
Morgan Stanley 22nd Annual Global Healthcare Conference22 Jan 2026 - Rapid Pemgarda launch targets unmet needs in immunocompromised COVID-19 patients.IVVD
H.C. Wainwright 26th Annual Global Investment Conference 202421 Jan 2026 - PEMGARDA shows 84%-85% efficacy in COVID-19 prevention, targeting millions at high risk.IVVD
2024 Cantor Fitzgerald Global Healthcare Conference20 Jan 2026 - Pemgarda leads COVID-19 prevention for immunocompromised, with strong efficacy and market growth.IVVD
Guggenheim Securities Inaugural Healthcare Innovation Conference14 Jan 2026
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