PRVB - Provention climbs 27% as FDA proposes labeling for experimental diabetes drug

• Provention Bio, Inc. ( NASDAQ: PRVB ) added ~27% intraday Thursday after the clinical-stage biopharma announced with its Q3 2022 results that the FDA issued its proposed labeling for the experimental diabetes therapy teplizumab.
• An anti-CD3 monoclonal antibody, teplizumab, is currently under the FDA review for type 1 diabetes in at-risk individuals, with an action date on Nov. 17.
• "….we are pleased to report that we have received both the FDA's proposed labelling and post-marketing requirements and commitments, and that these are generally consistent with our expectations," Chief Executive Ashleigh Palmer remarked.
• Provention ( PRVB ) said cash and equivalents at the end of the quarter reached $186.5M after the cash-based operating expenses for the period stood at $26.4M. However, it expects cash-based operating expenses for the current quarter to reach $40M – $45M assuming a potential commercial launch of teplizumab.
• In October, the company and Sanofi ( SNY ) ( OTCPK:SNYNF ) ( GCVRZ ) entered into a co-promotion agreement for teplizumab.

For further details see: