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.
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June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.