Avadel Pharmaceuticals Announces Favorable Ruling Regarding Sleep Disorder Drug Patent

Benzinga
2022-11-21
  • Avadel Pharmaceuticals plc (NASDAQ: AVDL) announced that the United States District Court for the District of Delaware ordered Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) to delist U.S. Patent No. 8731963 (the REMS Patent) from the FDA Orange Book. 
  • With this decision, Avadel seeks to accelerate the FDA's final approval for Lumryz, a once-at-bedtime formulation of sodium oxybate for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
  • In July, Lumryz received tentative approval from the FDA, with potential final approval pending the disposition of the REMS Patent. 
  • Price Action: Avadel Cuts Workforce, Optimizes Cost Structure.
  • In October, a Markman hearing was held in which Avadel renewed its request for expedited consideration of its pending motion to have the REMS Patent delisted from the FDA's Orange Book. 
  • The Delaware Court granted that request and held a hearing on that motion. 
  • Avadel is currently evaluating the long-term safety and tolerability of Lumryz in the open-label RESTORE clinical study. 
  • Price Action: AVDL shares are 0.12% lower at $8.01 during premarket trading on Monday.

See more from Benzinga

  • Warren Buffett's Berkshire Boosts Stake In Five Japanese Trading Houses
  • Carvana Faces Heat Of Slowing Demand, Higher Interest Rates

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

免责声明:投资有风险,本文并非投资建议,以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请,作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考,不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证,投资者应自行研究并在投资前寻求专业建议。

热议股票

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10