|Day's Range||1.7500 - 1.9000|
Avadel Pharmaceuticals plc (AVDL), a company focused on developing FT218 for narcolepsy, today announced it will present two posters at the 33rd Annual Meeting of the Associated Professional Sleep Societies being held in San Antonio, Texas, from June 8-12, 2019. “Our once-nightly controlled-release sodium oxybate demonstrated lower overall peak plasma concentrations (Cmax) and similar total exposures (AUC), compared to twice-nightly sodium oxybate in a head-to-head study,” said Jordan Dubow, MD, Chief Medical Officer of Avadel Pharmaceuticals.
Avadel Pharmaceuticals plc (AVDL), a company focused on developing FT218 for narcolepsy, today announced the appointment of Gregory J. Divis as Chief Executive Officer and member of the Board of Directors. “Since being named Interim CEO at the beginning of 2019, Greg has done an excellent job leading the Company through rapid restructuring while directing our focus toward the successful development of FT218, our novel once-nightly therapy for narcolepsy patients,” said Geoffrey Glass, Chairman of Avadel’s Board of Directors.
DUBLIN, Ireland, May 22, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (AVDL), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the Company’s fourth Hospital Product, AV001. It has been granted Priority Review status by the FDA resulting in a six-month review period. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 15, 2019.
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The Dublin-based company said it had a loss of 35 cents per share. The specialty pharmaceutical company posted revenue of $16.4 million in the period. The company's shares closed at $1.20. A year ago, ...
REST-ON 63% enrolled; 98 patients remain to be enrolled Jordon Dubow, M.D., appointed as Chief Medical Officer Noctiva™-related assets sold; all operational activities have.
NEW YORK, NY / ACCESSWIRE / May 8, 2019 / Avadel Pharmaceuticals Plc (NASDAQ: AVDL ) will be discussing their earnings results in their 2019 First Quarter Earnings to be held on May 8, 2019 at 8:30 AM ...
DUBLIN, Ireland, April 29, 2019 -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218 for sleep disorders, today announced that it will host a.
Avadel Pharmaceuticals plc (AVDL), a company focused on developing FT218 for sleep disorders, today announced that it has appointed Jordan Dubow, M.D., as Chief Medical Officer. Dr. Dubow brings extensive experience leading clinical development programs in sleep and neurological disorders to Avadel, where he will lead the development of FT218 for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. “Dr. Dubow’s experience in a wide range of neurological disorders, especially sleep, will be invaluable to Avadel as we continue advancing FT218 toward approval and commercialization,” said Geoff Glass, Chairman of Avadel Pharmaceuticals.
Jazz Pharmaceuticals (JAZZ) announced positive top-line data from its phase III study on low sodium formulation of Xyrem, JZP-258.
The FDA will provide its decision on Jazz's (JAZZ) candidate, solriamfetol, for excessive daytime sleepiness with narcolepsy on Wednesday.
The Dublin-based company said it had a loss of $1.72 per share. The specialty pharmaceutical company posted revenue of $20.9 million in the period. For the year, the company reported a loss of $95.3 million, ...
DUBLIN, Ireland, March 15, 2019 -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218 for sleep disorders, today announced its financial results.
Avadel Pharmaceuticals plc (AVDL), a company focused on developing FT218 for sleep disorders, today announced that it will host a conference call and live webcast discussion at 8:30 a.m. EDT on Friday, March 15, 2019, to provide a corporate update and discuss details of the Company's financial results for the quarter and year ended December 31, 2018. A live audio webcast can be accessed by visiting the investor relations section of the Company’s website, www.avadel.com. Avadel Pharmaceuticals plc (AVDL) is a branded specialty pharmaceutical company. Our primarily focus is on the development and potential FDA approval for FT218 which is in a Phase III clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, we market three sterile injectable drugs used in the hospital setting which were developed under our “unapproved marketed drug” (UMD) program. The Company is headquartered in Dublin, Ireland with operations in St. Louis, Missouri and Lyon, France.
Avadel Pharmaceuticals plc (AVDL) provided clarification regarding the restructuring actions announced earlier today. The restructuring actions do not trigger a default or violate covenants related to the 4.50% Exchangeable Senior Notes due in 2023.
Avadel Pharmaceuticals plc (AVDL), today announced a corporate restructuring to assure the financial health required to maximize the value of FT218, currently in Phase III development for the treatment of excessive daytime sleepiness (EDS) and Cataplexy in patients suffering from Narcolepsy. Avadel expects to realize $70 to $75 million in cost reductions in 2019 as compared to 2018 as a result of the restructuring plan, driven primarily by exiting NOCTIVA™. “It is clear that FT218, an investigational, once-nightly formulation of sodium oxybate, is the Company’s most promising and commercially-attractive asset targeting a large orphan market with an estimated value of nearly $1.5 billion in 2018,” said Greg Divis, interim Chief Executive Officer of Avadel.
WASHINGTON, Jan. 23, 2019 -- A new awareness campaign called ‘Sleep Normal’ launched Monday to raise awareness of nocturia, an underdiagnosed, treatable, medical condition that.
We've lost count of how many times insiders have accumulated shares in a company that goes on to improve markedly. Unfortunately, there are also plenty of examples of share prices Read More...
- Michael S. Anderson resigns as Chief Executive Officer and member of Avadel’s Board of Directors – - Gregory J. Divis, current Avadel Chief Operating Officer, named Interim.
Jazz (JAZZ) announces that the FDA has extended the review period of its new drug application for sleep drug, solriamfetol, by three months to Mar 20, 2019.
Avadel Pharmaceuticals plc (AVDL), a company focused on providing innovative medicines for chronic urological, central nervous system, and sleep disorders, today announced that Kevin Kotler, the founder and Portfolio Manager of Broadfin Capital, LLC, has been appointed to the Company’s Board of Directors and will immediately join the Board. The Company also intends to nominate and appoint an additional director, in consultation with Broadfin, in the very near future.
NEW YORK, Dec. 11, 2018 -- In new independent research reports released early this morning, Fundamental Markets released its latest key findings for all current investors,.
WASHINGTON, Nov. 29, 2018 -- Nov. 25-30 acknowledges Nocturia Awareness Week, part of Bladder Health Month, which encourages people to take control of their urinary health..
The Dublin-based company said it had a loss of 43 cents per share. The specialty pharmaceutical company posted revenue of $19.8 million in the period. Avadel expects full-year revenue in the range of $90 ...