VBY329 — IND submission
H2 2026
We expect to advance VBY329 toward IND readiness in the second half of 2026.Source filing
IVVD biotech catalysts & pipeline
INVIVYD INC · Data as of 2026-10-25
Upcoming catalysts
VMS063 — IND submission
late 2026
Invivyd has begun Investigational New Drug (IND)-enablement and regulatory outreach to support rapid VMS063 development; goal is expedited development with target IND readiness in late 2026.Source filing
VYD2311 — Topline data
Oct 2026
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; DECLARATION topline data on safety and immunogenicity to support the submission are now expected in October; DECLARATION clinical efficacy data will be planned to be unblinded post-Accelerated Approval, if granted, subject to clinical event accrualSource filing
VYD2311 — NDA/BLA submission
Dec 2026
As a result of those discussions, Invivyd intends to submit a BLA under the Accelerated Approval Program pending results from the ongoing DECLARATION pivotal study.Source filing
VYD2311 — Initial data
mid-2027
Initial data expected in mid-2027.Source filing
PEMGARDA (pemivibart) — Regulatory decision
Jun 29
Consequently, the EUA for PEMGARDA is set to terminate on June 29, 2027.Source filing