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.
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