Shares of Provention Bio (NASDAQ:PRVB) -- a clinical-stage biotech company -- jumped by 9.4% on Monday after the drugmaker reported positive data from a clinical trial for one of its lead pipeline candidates, teplizumab (PRV-031).
Provention Bio has big ambitions: The company is looking to develop a drug that can delay the onset of diabetes in patients who are at risk of developing the condition. In June 2019, Provention Bio announced positive results from a clinical trial for teplizumab. During the trial, a 14-day course of teplizumab delayed the onset and diagnosis of type 1 diabetes by a median of two years in at-risk patients. The data showed that only 43% of patients on teplizumab developed diabetes, compared to 72% in the placebo group.
Today, Provention Bio announced additional data showing that teplizumab delayed the onset and diagnosis of type 1 diabetes by a median of three years, which is better than the two years' delay the company had previously reported. In April, Provention Bio initiated a rolling submission for its Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for teplizumab. The rolling submission allows the company to submit completed sections of its BLA for review, as opposed to submitting every completed section at once.
Provention Bio's teplizumab is a promising drug, and if it is approved, it could become a blockbuster product. Diabetes is a serious health condition that affects millions of Americans, and the diabetes market represents a multi-billion dollar opportunity. Given these factors, investors might want to keep an eye on this small-cap biotech stock.