Biopharma Transcript

Invivyd, Inc. IVVD

Nasdaq · Phase 3 · infectious disease · antibody · EDGAR · Updated Nov 4, 2026

Invivyd, Inc. (Nasdaq: IVVD) is an infectious disease drug developer. Its lead program, VYD2311, is in Phase 3 for COVID-19 prevention/treatment (DECLARATION and LIBERTY Phase 3).

Upcoming catalysts

No catalyst is dated to the next 30 days or to an FDA action date.

Pipeline

ProgramIndicationModalityStage
VYD2311COVID-19 (DECLARATION, ~2,400 participants)antibodyPhase 3
VYD2311COVID-19 (LIBERTY)antibodyPhase 3
VBY329RSVantibodyPre-clinical
VMS063measlesantibodyPre-clinical

Recent results and decisions

  1. Sep 29, 2026
    met Met co-primary endpoints: any TEAE/ISR/hypersensitivity at 6 days 56.5% vs 91.4% for mRNA vaccine (p<0.0001); systemic AEs 44.1% vs 68.1% (p=0.008).VYD2311 met all primary and secondary endpoints comparing VYD2311 to an mRNA-based COVID-19 vaccine, demonstrating VYD2311 safety and tolerability that is clinically and statistically superior to the safety and tolerability of an mRNA-based COVID-19 vaccine Filing
  2. Sep 29, 2026
    n/a Invivyd plans to submit a BLA for VYD2311 to the U.S. FDA via Accelerated Approval Program following DECLARATION data.Invivyd plans for DECLARATION and LIBERTY clinical studies to be the basis of a planned Biologics License Application (BLA) submission for VYD2311 to the U.S. Food and Drug Administration via Accelerated Approval Program following a recent Type C meeting Filing
  3. Mar 5, 2026
    completed enrollment DECLARATION Phase 3 reported fully enrolled; IDMC safety review allowed pregnant and breastfeeding women to enroll.Following trial initiation in late 2025, the DECLARATION pivotal clinical trial recruitment has progressed rapidly with full enrollment achieved. Filing

2 more on record.

For subscribers

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