Why Provention Bio Stock Is Trading Higher Today?

The FDA published Provention Bio Inc’s PRVB teplizumab-related briefing documents ahead of an Advisory Committee meeting scheduled for May 27 (Thursday).
The agency sounded a relatively positive tone on safety and efficacy after identifying deficiencies that preclude discussion of labeling and post-marketing requirements.
The company seeks approval for teplizumab for 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, stated the document.
In the pivotal TN-10 study, a single 14-day course of teplizumab was well tolerated and resulted in a 2-year delay in the progression to Stage 3 insulin-dependent 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 April, the FDA identified deficiencies expressing concerns over teplizumab pharmacokinetics data and comparability when Lilly first put teplizumab into clinical trials.
Price Action: PRVB shares are up 27.1% at $10.14 during the market session on the last check Tuesday.
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