Invivyd Inc. said it has received federal approval to begin large-scale testing of a new drug designed to prevent COVID-19 infections.
Invivyd Inc., a New Haven-based biotechnology company developing antibody-based treatments, said Monday it has received federal approval to begin large-scale testing of a new drug designed to prevent COVID-19 infections.
The company said the U.S. Food and Drug Administration cleared its application to start two late-stage clinical trials for the experimental therapy, known as VYD2311. One study will measure how well the drug prevents infection, while another will test its safety and compare immune responses to traditional COVID-19 vaccines.
Invivyd said it expects to begin enrolling participants by the end of the year and aims to have early results by mid-2026. The company said it already has commercial-scale quantities of the drug and will use proceeds from a recent capital raise to fund the trials.
The studies are part of Invivyd’s broader effort to develop longer-lasting protection against COVID-19, especially for people with weakened immune systems, the company said.
Invivyd shares trade on the Nasdaq under the ticker IVVD. The company lists its headquarters at 209 Church St., in New Haven.
