The FDA told Provention Bio Inc. that its BLA under priority review for teplizumab needs some work but the May 27 advisory committee meeting to discuss the application in full is still on the calendar.
Anti-drug antibodies noted in the phase Ib portion of the PREVAIL study in lupus drew queries for Oldwick, N.J.-based Provention Bio Inc. during a conference call related to earnings, but analysts seemed more interested in the company’s later-stage push in type 1 diabetes (T1D).
