PRVB - Provention Bio soars as FDA posts report on teplizumab ahead of AdCom meeting

Provention Bio (PRVB) has gained ~36.7% in the pre-market after the FDA published the briefing documents for teplizumab ahead of an Advisory Committee meeting scheduled for May 27.The company seeks approval for teplizumab in the delay of progression to clinical type 1 diabetes (T1D) in at-risk patients.The approval could make teplizumab the first disease-modifying therapy that preserves beta-cell function for patients with stage 2 of the disease who are at risk of progressing to stage 3 clinical T1D.“The totality of the efficacy and safety data strongly supports the positive benefit/risk of teplizumab for the delay of progression to Stage 3 clinical T1D in at-risk patients with pre-symptomatic Stage 2 T1D,” according to the FDA document.In late April, the company announced a potential delay in the approval for teplizumab citing deficiencies identified by the FDA in connection with its marketing application.

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Provention Bio soars as FDA posts report on teplizumab ahead of AdCom meeting