Avadel ADRs Tumble 14% Following Lawsuit Trying to Overturn FDA Approval of Similar Drug
23 Juin 2023 - 6:12PM
Dow Jones News
By Denny Jacob
American depositary receipts of Avadel Pharmaceuticals tumbled
14% to $13.13 on Friday after a lawsuit was filed in the U.S.
District Court for the District of Columbia alleging that the U.S.
Food and Drug Administration unlawfully approved the company's new
drug application for Lumryz.
Avadel's ADRs, which are up 83% on the year, are on pace for
their largest percentage decrease since May 2022 when they fell
over 68%.
Ireland-based biopharmaceutical company Jazz Pharmaceuticals
said Thursday in a regulatory filing that its lawsuit alleged that
the FDA acted outside its authority under the Orphan Drug Act when
it approved Lumryz's new drug application and granted it orphan
drug exclusivity.
The lawsuit alleged the FDA acted without lawful basis when the
agency determined that Lumryz boosted patient care and was
purportedly clinically superior to two similar drugs that Jazz
Pharmaceutical produces, Xywav and Xyrem.
Jazz Pharmaceuticals said Xywav already had orphan drug
exclusivity and described Lumryz as an extended-release
reformulation of Xyrem. The drugs treat cataplexy, or excessive
daytime sleepiness, in adults with narcolepsy.
Avadel Pharmaceuticals didn't immediately respond to a request
for comment from Dow Jones Newswires.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
June 23, 2023 11:57 ET (15:57 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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