Provention Bio (NASDAQ:PRVB) perks up 5% premarket on modest volume in reaction to its announcement that it continues to expect to start its rolling U.S. marketing application in mid-2020 for lead candidate PRV-031 (teplizumab) for the prevention or delay of type 1 diabetes (T1D) in at-risk people. The filing should be completed by Q4 2020.
A recent meeting with the FDA clarified the required contents of the application.
Teplizumab is a CD3-targeted monoclonal antibody designed to slow the loss of insulin-producing beta cells in the pancreas while preserving beta cell function as measured by C-peptide.
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