- The FDA has designated Xeris Pharmaceuticals's (NASDAQ:XERS) XP-0863 (diazepam non-aqueous injection) for fast track review for the treatment of acute repetitive seizures.
- XP-0863 was previously granted orphan designations both for the treatment of acute repetitive seizures and for the treatment of Dravet Syndrome.
- Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
- https://seekingalpha.com/news/3623914-xeris-pharmas-xpminus-0863-fast-trackd-in-u-s-for-repetitive-seizures
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Tuesday, October 20, 2020
Xeris Pharma's XP-0863 Fast Track'd in U.S. for repetitive seizures
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