AVDL - Avadel Pharma shares gain on FDA acceptance of FT218 application

The FDA accepts for review Avadel Pharmaceuticals' (AVDL) New Drug Application ((NDA)) for FT218, an once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.The PDUFA target action date is October 15, 2021. The NDA submission is supported by positive data from the  Phase 3 REST-ON study. Study data will be presented at upcoming conferences in H1. FT218 has been granted Orphan Drug Designation in U.S. for the treatment of narcolepsy.AVDL shares are up 6% premarket, currently trading at $8.49.

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Avadel Pharma shares gain on FDA acceptance of FT218 application