What happened
Shares of Provention Bio (NASDAQ: PRVB) were skyrocketing 30.8% higher as of 3:41 p.m. ET on Monday. The big jump continued the momentum that began on Friday after the drugmaker announced that it intends to refile for approval of teplizumab for delaying type 1 diabetes.
So what
Some investors had given up on Provention after the U.S. Food and Drug Administration (FDA) rejected approval of teplizumab in July of last year. However, the company had a productive meeting with the FDA recently. As a result, Provention plans to resubmit its Biologic License Application (BLA) for the experimental therapy within the next couple of months.
Image source: Getty Images.
Teplizumab is Provention's lead pipeline candidate. The anti-CD3 monoclonal antibody demonstrated in clinical testing that it could delay the onset of type 1 diabetes in at-risk individuals.
The market potential for teplizumab could be significant if it wins FDA approval. No disease-modifying therapies for type 1 diabetes have been approved since the development of insulin more than 100 years ago.
Now what
After Provention resubmits the BLA for the therapy, the agency will have 30 days to review the filing and provide a PDUFA date (the date for announcing an approval decision). With teplizumab previously receiving both Breakthrough Therapy designation and Priority Review designation from the agency, it's possible that Provention could have its first approved drug in the fourth quarter of 2022.
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