With clearer path to approval, Provention’s teplizumab poised to break new ground in Type I diabetes 

FDA briefing documents for teplizumab helped shares of Provention recover lost ground from a pair of April setbacks and suggest a clearer path to FDA approval of the Type I diabetes therapy than might have been expected a month ago. But a return to the stock’s 52-week high will likely depend on whether the therapy can deliver on its goal of delaying the loss of insulin-producing cells in at-risk individuals.

Shares of Provention Bio Inc. (NASDAQ:PRVB) rose $2.14 (27%) to $10.12 Tuesday, and continued to glide as much as 8% higher in after-hours trading, after comments by FDA reviewers indicated that the agency believes deficiencies in data for the humanized anti-CD3 mAb would not prevent the agency from approving the therapy...