Avadel Pharmaceuticals Shares Drop 21% After FDA Notification on Narcolepsy Drug
October 18 2021 - 6:52AM
Dow Jones News
By Chris Wack
Avadel Pharmaceuticals PLC shares were down 21% to $7.91 in
premarket 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 company said the FDA 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 have 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 06:37 ET (10:37 GMT)
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