PRVB - Provention Bio jumps 12% after providing regulatory update for teplizumab

Provention Bio (NASDAQ:PRVB) soars 12% premarket after providing an update related to the Complete Response Letter (CRL) issued in July 2021 for Biologics License Application (BLA) for teplizumab. On November 18, 2021, the Company had a Type A meeting with the FDA to discuss the population pharmacokinetic (popPK) model to be used for planned commercial and clinical drug product comparison. In preliminary meeting comments, the FDA approved the Company proceeding to populate the popPK model with data collected from patients receiving therapeutic doses of teplizumab in a pharmacokinetic/pharmacodynamic (PK/PD) sub-study of the ongoing PROTECT Phase 3 trial in newly diagnosed type 1 diabetes (T1D) patients. The company says preliminary results support comparability of teplizumab commercial product and clinical drug product. The Company's preliminary analysis from the popPK model produced the following top-line results: Geometric mean of the ratio of commercial to clinical drug product [90% Confidence Interval (CI)] 83.2% AUC Infinity [CI: 76.9

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Provention Bio jumps 12% after providing regulatory update for teplizumab