AVADEL PHARMACEUTICALS PLC

(AVDL)
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Delayed Nasdaq  -  04:00 2022-06-24 pm EDT
2.310 USD   -4.94%
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Avadel Pharmaceuticals Shares Drop 42% After FDA Makes Requests for FT218

05/26/2022 | 08:05am EDT

By Chris Wack


Avadel Pharmaceuticals Plc shares were down 42% to $1.97 after the company said in a filing that it received a proposed, final label and medication guide for FT218 from the U.S. Food & Drug Administration.

FT218 is the company's lead drug candidate, an investigational formulation of sodium oxybate designed to be taken once at bedtime for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy.

The company also said it was notified by the FDA that the FT218 New Drug Application patent statement pertaining to its U.S. REMS patent was deemed inappropriate by the FDA.

The FDA has requested the company add a certification to the REMS patent to its NDA. The FDA further confirmed, based on the final proposed label, that no additional patent certifications will be required.

Avadel now anticipates tentative approval of the FT218 NDA with potential full approval on or before the expiration of the REMS patent on June 17, 2023. Full approval could occur sooner if the REMS patent is delisted from the FDA's Orange Book, a court determines the patent is invalid, not infringed or otherwise unenforceable, or a court determines that the FDA erred in requesting a certification.


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


(END) Dow Jones Newswires

05-26-22 1005ET

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Financials (USD)
Sales 2022 - - -
Net income 2022 -99,8 M - -
Net cash 2022 54,1 M - -
P/E ratio 2022 -1,48x
Yield 2022 -
Capitalization 136 M 136 M -
EV / Sales 2022 -
EV / Sales 2023 11,0x
Nbr of Employees 66
Free-Float 60,4%
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Mean consensus BUY
Number of Analysts 10
Last Close Price 2,31 $
Average target price 9,50 $
Spread / Average Target 311%
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Managers and Directors
Gregory J. Divis Chief Executive Officer & Director
Thomas S. McHugh Chief Financial Officer & Senior Vice President
Geoffrey Michael Glass Non-Executive Chairman
Jason Vaughn Senior Vice President-Technical Operations
Jennifer Gudeman Vice President-Medical & Clinical Affairs
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