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DATA GRAPHICS | Data Byte

At least nine PDUFA dates on deck in March

Decisions include leniolisib and trofinetide, both of which could be the first drugs approved for their indications 

March 2, 2023 1:49 AM UTC

FDA has goal dates in March for at least nine applications, six of which would be new therapies. 

First up, on March 12, is the PDUFA date for trofinetide from Acadia Pharmaceuticals Inc. (NASDAQ:ACAD). If approved, the synthetic IGF-1 analog would be the first therapy available for Rett syndrome, a rare neurodevelopmental disorder that occurs mostly in females. An approval would make Acadia eligible for a priority review voucher, as the therapy has rare pediatric disease designation. Acadia licensed North American rights to trofinetid in 2018 from Australia-based  Neuren Pharmaceuticals Ltd. (ASX:NEU; Pink:NURPF), which is eligible for double-digit royalties and one third of the market value of the voucher...

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