PRVB - Provention Bio says FDA extends review period for co's teplizumab application to Nov. 17
- Provention Bio ( NASDAQ: PRVB ) on Thursday said the U.S. FDA had extended its review period for the company's biologics license application for its lead drug candidate teplizumab by three months.
- The FDA is now set to decide on the application on or before Nov. 17.
- The FDA also informed PRVB that if no deficiencies are identified during the review period, then the regulator plans to inform the company on proposed labeling and any post-marketing requirements, if necessary, by Oct. 17.
- "We are committed to collaborating closely with the (FDA) as it completes its review," said PRVB CEO Ashleigh Palmer.
- PRVB stock earlier closed +2.3% at $4.
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Provention Bio says FDA extends review period for co's teplizumab application to Nov. 17