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Valneva, LimmaTech Get FDA Fast Track Designation for Shigellosis Vaccine Candidate
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Valneva, LimmaTech Get FDA Fast Track Designation for Shigellosis Vaccine Candidate
Oct 17, 2024 1:44 PM

12:25 PM EDT, 10/16/2024 (MT Newswires) -- 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

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