Aquestive Therapeutics Shares Drop 33% Premarket After FDA Notice
21 December 2021 - 11:30PM
Dow Jones News
By Chris Wack
Aquestive Therapeutics Inc. shares were down 33% to $4.19 in
premarket trading after the company said the Food and Drug
Administration sent a notice regarding the review of the new-drug
appliation for its Libervant diazepam buccal film for the treatment
of breakthrough seizures and seizure clusters.
The pharmaceutical company said the notice was to notify it that
the FDA is still considering regulatory issues related to the
approvability of Libervant, and that it won't be ready to take an
action by Thursday.
The FDA notice said that no additional information is needed at
this time, and that it is currently unable to provide an estimate
of the timing of an expected action, the company said.
"We are surprised to receive this notification from the FDA,"
said Keith Kendall, chief executive of Aquestive. "We accepted all
of the agency's label edits for Libervant last week and, as the
agency stated in its notice today, there is no additional
information needed from the company at this time."
Aquestive said it is reaching out to the FDA to seek further
clarity.
In July, the FDA accepted the NDA for Libervant and assigned a
Prescription Drug User Fee Act target goal date of Dec. 23,
2021.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
December 21, 2021 07:15 ET (12:15 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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