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Biotech Stocks Facing FDA Decision In October 2021

Avadel Pharmaceuticals
Avadel Pharmaceuticals

Avadel Pharmaceuticals plc’s (AVDL) lead drug candidate FT218 awaits the FDA decision on October 15, 2021.

FT218 is an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.

Narcolepsy is a sleep disorder characterized by excessive sleepiness, sleep paralysis, hallucinations, and in some cases episodes of cataplexy (partial or total loss of muscle control, often triggered by a strong emotion such as laughter).

Sodium Oxybate is marketed by Jazz Pharma as Xyrem in a twice nightly formulation for cataplexy and excessive daytime sleepiness in patients with narcolepsy. Xyrem’s annual net product sales in 2020 were $1.74 billion, up 6% over 2019.

AVDL closed Wednesday’s trading at $9.91, up 0.51%.