By Chris Wack 
 

Avadel Pharmaceuticals PLC shares cut their losses, but were recently down 14% at $8.53 in midday trading after the company said Friday that the U.S. Food and Drug Administration's review of the new drug application for FT218 is still ongoing and action will likely not be taken in October.

The stock, which was down more than 20% premarket, had a volume of 2.2 million shares at 12:25 p.m. ET. compared to its 65-day average volume of 466,000 shares. The stock hit its 52-week high of $10.80 on Oct. 4.

Avadel said the FDA has notified the company that there are no information requests at this time and a new target action date would be provided as soon as possible.

FT218 is designed to be taken once at bedtime for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy.

Avadel said it has addressed all questions received to date, and it remains confident that the package it had submitted satisfies all of the FDA's requests. It hasn't been informed of any deficiencies in its application.

In February, the FDA accepted Avadel's application for FT218 and assigned a target action date of Oct. 15. The NDA submission is supported by data from a Phase 3 study.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

October 18, 2021 12:43 ET (16:43 GMT)

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