- Provention Bio (NASDAQ:PRVB) has completed its rolling U.S. marketing application for teplizumab for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk people, a Breakthrough Therapy-tagged indication. The company has requested Priority Review which, if granted, will shorten the review clock to six months.
- If all goes well, market launch will commence in 2021.
- Teplizumab is a CD3-targeted monoclonal antibody designed to slow the loss of insulin-producing beta cells in the pancreas while preserving beta cell function as measured by C-peptide.
- https://seekingalpha.com/news/3629602-provention-bio-completes-u-s-application-for-diabetes-prevention-med
Monday, November 2, 2020
Provention Bio completes U.S. application for diabetes prevention med
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