Valneva (VALN) and LimmaTech Biologics got a fast track designation from the US Food and Drug Administration for their tetravalent bioconjugate shigellosis vaccine candidate.
The expected regulatory pathway for Shigella4V involves a combination of controlled human infection model studies to support potential initial approval in adults, followed by field efficacy studies for the possible expansion to children, the companies said Wednesday in a statement.
In August, Valneva entered into a partnership and exclusive licensing agreement with LimmaTech2 for the development, manufacturing and commercialization of Shigella4V.
Shares of Valneva jumped 6.4% in recent trading Wednesday.
Price: 5.84, Change: +0.35, Percent Change: +6.37
Comments