regulatory
confidence high
sentiment neutral
materiality 0.60
Invivyd to pursue EUA for pemivibart for COVID-19 treatment in immunocompromised
Invivyd, Inc.
- 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.