Invivyd submits XEC variant data to FDA supporting pemivibart treatment EUA amendment

Invivyd, Inc.

Updated immunobridging analysis with XEC variant shows pemivibart titers substantially exceed adintrevimab in Days 0-5.
Adintrevimab previously showed 66-74% risk reduction in hospitalization/death vs placebo in STAMP trial.
No additional anaphylaxis reports during post-authorization use of PEMGARDA for COVID-19 PrEP to date.
Submission consistent with prior analyses since July 2024; FDA review ongoing with no statutory deadline.

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