Invivyd's COVID-19 Vaccine-Alternative Antibody VYD2311 Granted FDA Fast Track Status

(RTTNews) - Invivyd, Inc. (IVVD) on Tuesday said the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VYD2311, the company's vaccine-alternative antibody candidate to prevent COVID-19.

Programs with Fast Track designation may qualify for priority review and rolling Biologics License Application (BLA) submissions, potentially shortening regulatory timelines.

The company's BLA-enabling study of VYD2311, dubbed DECLARATION, is underway, with top-line data expected by mid-2026.

Invivyd shares were more than 2% up in pre-market, after closing at $2.88, up 25.21% on Monday.