Provention Bio Shares Gain On Teplizumab Regulatory Update For Type 1 Diabetes

The FDA has approved Provention Bio Inc's PRVB proceeding to populate the popPK model with data collected from patients receiving therapeutic doses of teplizumab PK/PD substudy.

• Related Link: Provention Bio's Teplizumab Application Receives CRL For Type-1 Diabetes; Stock Drops
• The substudy is a part of the ongoing PROTECT Phase 3 trial in newly diagnosed type 1 diabetes (T1D) patients.
• Last week, the Company had a Type A meeting with the FDA to discuss the population pharmacokinetic (popPK) model for planned commercial and clinical drug product comparison. 
• Given teplizumab's target-mediated clearance mechanism, the difference in exposure between commercial and clinical drug products in healthy volunteers is greatly reduced when the products are administered.
• The FDA is conducting an independent review of the data and may have a different opinion.
• Related content: Benzinga's Full FDA Calendar.
• Price Action: PRVB shares are up 16.5% at $7.27 during the market session on the last check Monday.