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FDA grants RPD status to Anavex 2-73; shares ahead 7% premarket

  • The FDA grants Rare Pediatric Disease (RPD) designation to Anavex Life Sciences' (NASDAQ:AVXL) lead drug Anavex 2-73 (blarcamesine) for the treatment of a rare inherited neurological disorder called Rett syndrome that affects mostly girls.
  • RPD Designation provides for the issuance of a rare pediatric disease priority review voucher following FDA approval. The voucher can be used for accelerated approval of a future application or it can be sold to a third party.
  • Phase 2 studies are in process.
  • Shares up 7% premarket on light volume.

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