Avadel Pharmaceuticals Shares Drop 14% After FDA Notification
19 10월 2021 - 1:58AM
Dow Jones News
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)
Copyright (c) 2021 Dow Jones & Company, Inc.
Avadel Pharmaceuticals (NASDAQ:AVDL)
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부터 6월(6) 2024 으로 7월(7) 2024
Avadel Pharmaceuticals (NASDAQ:AVDL)
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부터 7월(7) 2023 으로 7월(7) 2024
