secwatch.observer — SEC 8-K summary
======================================

Issuer:     Invivyd, Inc. (IVVD)
CIK:        0001832038
Form:       8-K
Filed at:   2026-09-29T11:26:46+00:00
Accession:  0001193125-26-406007
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Invivyd's VYD2311 bests COMIRNATY on safety in LIBERTY Phase 3; BLA via Accelerated Approval planned
--------------------------------------------------------------------------------

- LIBERTY randomized 210 healthy adults (18-49) 1:1:1 to 250mg VYD2311, COMIRNATY mRNA vaccine, or both; VYD2311 met all primary and secondary endpoints.
- 6-day TEAE/ISR/hypersensitivity: VYD2311 56.5% vs vaccine 91.4% (P<0.0001); 56-day rate 60.9% vs 91.4% (P<0.0001); combo arm 83.1% (P=0.21).
- Systemic AEs at 6 days: 44.1% for VYD2311 vs 68.1% for mRNA vaccine (P=0.008); combination 50.0% vs 68.1% (P=0.023).
- No VYD2311-related AE above Grade 2 and no hypersensitivity or anaphylaxis in any arm; co-administration raised vaccine neutralizing titers ~2.5x with no immunologic interference.
- After a September Type C meeting, Invivyd plans a BLA under Accelerated Approval; DECLARATION safety/immunogenicity topline data expected in October, efficacy unblinded post-approval.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1832038/000119312526406007/0001193125-26-406007-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1832038/000119312526406007/ivvd-20260929.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-406007

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer