Feb. 3 at 12:29 PM
$IVVD $1.81 bid. EXIT
$6.00
Holding long position at a loss.
BRIEF: Invivyd has received and is aligned with advice from the U.S. Food and Drug Administration on the LIBERTY Phase 3 clinical trial, which will assess the safety and immunologic profile of VYD2311, the company’s vaccine- alternative monoclonal antibody investigational candidate for the prevention of COVID-19, versus commercially available mRNA COVID vaccines (1.74)
LIBERTY is part of the Company's broader REVOLUTION clinical program designed to elaborate the profile of monoclonal antibody-mediated prophylaxis from COVID-19 and the potential medical benefits to vulnerable Americans.
The LIBERTY clinical trial will evaluate comparative safety and immunology of VYD2311 versus mRNA COVIDvaccine, as well as explore the safety and immunology of co-administered VYD2311 and mRNA COVIDvaccine.
FDA, providing feedback jointly from CDER and CBER, requested specific monitoring of adverse events of special interest (AESIs) relevant to mRNA COVID vaccines, citing the known risk of myocarditis/pericarditis in the young adult population following mRNA COVID vaccination; no similar requests have been made for other Invivyd clinical trials without an mRNA COVID vaccine arm.
