AVDL - Avadel rises 18% as it expects tentative approval for sleep disorder drug; expects final approval by June 2023

• Avadel Pharmaceuticals ( NASDAQ: AVDL ) is trading 18% higher after the company said it expects to receive tentative approval from the U.S. FDA of its therapy FT218 to treat narcolepsy.
• The company said it was exploring every available pathway to accelerate the decision by the U.S. Food and Drug Administration (FDA) to grant final approval of its lead drug candidate prior to June 2023.
• The company also said a restructuring charge of between $3 - $4M, primarily comprising of severance related costs associated with a nearly 50% reduction in workforce, is expected to be recorded in Q2.
• The company estimates the treatment to have a potential market opportunity in excess of $3B annually.
• Narcolepsy is a chronic sleep disorder characterized by overwhelming daytime sleepiness.
• "We believe the receipt of a tentative approval for the FT218 New Drug Application (NDA) will validate the clinical efficacy and safety profile of FT218 for people living with narcolepsy and will provide clarity on the timing and pathway to a potential final approval and subsequent commercial launch," the company said.
• In October 2021 , the FDA had delayed to approve the company's new drug application for FT218 as said it needed more time to review.
• In May , the agency cited patent issues in FT218 drug filing.

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