Pemgarda maker Invivyd has a newer monoclonal antibody, VYD2311 which, according to one analyst offers a “much larger” total addressable market relative to Pemgarda. See the excerpts and a link to the full press release below!
NEW HAVEN, Conn., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VYD2311, an investigational vaccine-alternative monoclonal antibody candidate for the prevention of COVID.
“COVID is a critical ongoing endemic and chronic health challenge, and Americans need more options to prevent themselves from getting sick,” said Marc Elia, Chairman of Invivyd’s Board of Directors. “We are thrilled that the FDA recognizes the need to move quickly to prevent COVID as we move forward with our placebo-controlled, pivotal clinical trial DECLARATION.”
Invivyd previously announced initiation of DECLARATION, the company’s BLA-enabling clinical trial of VYD2311. Top-line data from the trial are expected mid-2026.