Provention Bio, Inc., a clinical stage biopharmaceutical company, focuses on the development and commercialization of therapeutics and solutions to intercept and prevent immune-mediated diseases. Its products candidates include PRV-031 teplizumab and monoclonal antibodies (mAb) that is in Phase III clinical trial for the interception of type one diabetes (T1D); PRV-6527, an oral CSF-1R inhibitor, which has completed Phase IIa clinical trial for the treatment of Crohn's disease; PRV-3279, which has completed Phase Ib clinical trial for the treatment of lupus; PRV-101, a coxsackie virus B (CVB) vaccine for the prevention of acute CVB infections and onset of T1D; and PRV-015, which is in phase IIb clinical trial for the treatment of gluten-free diet non-responding celiac disease. The company has a license and collaboration agreement with Amgen Inc. for PRV-015, a novel anti-IL-15 monoclonal antibody being developed for the treatment of gluten-free diet non-responsive celiac disease; and a strategic collaboration with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. to develop and commercialize PRV-3279, a bispecific antibody-based molecule targeting the B cell surface proteins CD32B and CD79B in Greater China. The company was incorporated in 2016 and is headquartered in Red Bank, New Jersey.
Fool.com - Shares of Provention Bio (NASDAQRVB) were soaring 21.6% as of 10:56 a.m. EDT on Tuesday. The big jump came after the U.S. Food and Drug Administration (FDA) released briefing documents in advance of an advisory committee meeting scheduled for May 27. This advisory committee will review Provention's Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals. So what Provention couldn't have asked for better news in the FDA's briefing documents. The agency stated that the company's TN-10 pivotal study "successfully demonstrated the treatment effect of teplizumab in delaying T1D diagnosis in at-risk relatives of T1D patients for a median time of approximately 2 years."
