Provention Bio : FDA Posts Briefing Documents On Type 1 Diabetes For May 27 Panel Meeting

(RTTNews) - Provention Bio Inc., (PRVB) said that the U.S. Food and Drug Administration posted briefing documents for the May 27, 2021 Endocrinologic and Metabolic Drugs Advisory Committee meeting to review the Biologics License Application for teplizumab, the company's investigational drug candidate for the delay of clinical type 1 diabetes in at-risk individuals.

In Tuesday regular trading, PRVB was trading at $10.27 up $2.29 or 28.76 percent.

The Advisory Committee meeting is scheduled for 9:00 a.m. EST on Thursday, May 27.

Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) with a filed BLA under Priority Review by the FDA for the delay of clinical type 1 diabetes in at-risk individuals.

On January 4, Provention Bio announced the FDA filing of the BLA and Priority Review for teplizumab for the delay of clinical T1D in at-risk individuals. Teplizumab has been granted Breakthrough Therapy Designation. Based on the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date for the BLA of July 2, 2021.