secwatch.observer — SEC 8-K summary
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Issuer:     Invivyd, Inc. (IVVD)
CIK:        0001832038
Form:       8-K
Filed at:   2026-04-09T23:59:59+00:00
Accession:  0001193125-26-148865
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Invivyd announces Phase 3 DECLARATION upsizing; new measles antibody VMS063
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- DECLARATION Phase 3 COVID-19 prophylaxis study upsized by ~500 subjects; top-line results now expected in Q3 2026, shifted from mid-2026.
- Pooled, blinded COVID-19 events at 1,500 subjects (Day 45) already support statistical power for high end of anticipated VYD2311 efficacy.
- FDA alignment on initial Pediatric Study Plan for VYD2311 (DRUMMER study) for children aged 0-11 years, contingent on DECLARATION success.
- New measles mAb candidate VMS063 targets F protein, shows potent in vitro neutralization (picogram/mL IC50s) across B3, D8, Edmonston lineages; IND-enablement started.
- VMS063 is half-life extended, planned for treatment and prophylaxis in measles; U.S. measles incidence in 2026 on track to exceed 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1832038/000119312526148865/0001193125-26-148865-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1832038/000119312526148865/d147019d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-148865

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