secwatch.observer — SEC 8-K summary
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Issuer:     Invivyd, Inc. (IVVD)
CIK:        0001832038
Form:       8-K
Filed at:   2024-05-07T23:59:59+00:00
Accession:  0001193125-24-132585
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Invivyd to pursue EUA for pemivibart for COVID-19 treatment in immunocompromised
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- Plans EUA submission for pemivibart to treat mild-to-moderate COVID-19 in moderately-to-severely immunocompromised people via immunobridging pathway.
- Immunobridging relies on Phase 2/3 STAMP trial data with adintrevimab and ongoing CANOPY trial for pemivibart PrEP.
- Manufacturing plan targets ~100,000 doses available through H2 2024 to serve both PrEP and potential treatment uses.
- 2024 net product revenue guidance remains $150-200M; year-end cash at least $75M, excluding potential treatment sales.
- After EUA submission, plans to initiate confirmatory safety, PK, and clinical virology trial.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1832038/000119312524132585/0001193125-24-132585-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1832038/000119312524132585/d823090d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-132585

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