Invivyd (IVVD) said Tuesday it has achieved alignment with the US Food and Drug Administration for a phase 3 trial to evaluate the safety and immunologic profile of its VYD2311 investigational antibody to prevent COVID-19, compared with commercially available mRNA COVID vaccines.

The study will also assess the safety and immunology of VYD2311 and mRNA COVID vaccine given at the same time, the company said.

Invivyd said the FDA, citing "known risk" of myocarditis/pericarditis in young adult Americans following mRNA COVID vaccination, asked that adverse events of special interest be specifically monitored in the study.

Invivyd shares were up over 4% in early trading Tuesday.