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Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a specialty pharmaceutical company headquartered in Dublin, Ireland, with operations in St. Louis, Missouri, and Lyon, France. The company focuses on developing, identifying, and commercializing differentiated pharmaceutical products designed to be safe, effective, and easy to administer, thereby improving patient adherence and outcomes. Avadel's products primarily target the urology, central nervous system (CNS) / sleep, and hospital markets.
One of Avadel's flagship products is LUMRYZ™, an extended-release formulation of sodium oxybate, approved by the U.S. Food & Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. LUMRYZ is notable for its once-at-bedtime dosing, which eliminates the need for a middle-of-the-night dose, making it more convenient for patients.
The FDA granted LUMRYZ seven years of Orphan Drug Exclusivity, recognizing it as a major contribution to patient care over existing therapies. The approval was supported by results from the REST-ON trial, a Phase 3 study that demonstrated significant improvements in EDS, the Clinician Global Impression of Improvement (CGI-I), and reduced the frequency of cataplexy attacks.
Avadel recently announced its financial results for the third quarter ended September 30, 2023, reporting $7.0 million in net product revenue from LUMRYZ sales. The company has seen robust demand and positive feedback from the narcolepsy community, healthcare providers, and payers. Notably, CVS Health has moved LUMRYZ to preferred status starting January 1, 2024. Avadel also filed a supplemental NDA to extend LUMRYZ's indication to pediatric patients with narcolepsy, further expanding its market reach.
Financially, Avadel reported a net loss of $36.3 million for the quarter, driven by higher selling, general, and administrative expenses related to the LUMRYZ launch. Despite these challenges, the company maintains a strong cash position of $153.2 million as of September 30, 2023.
Looking ahead, Avadel plans to issue its Annual Report on Form 10-K for the year ended December 31, 2023, on February 29, 2024. The company continues to focus on expanding its product pipeline, including initiating a Phase 3 trial for idiopathic hypersomnia and optimizing commercial execution for LUMRYZ.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced new findings at World Sleep 2022 regarding its lead drug candidate, FT218, an investigational formulation of sodium oxybate for narcolepsy. A discrete choice experiment revealed that patients and clinicians prefer once-nightly dosing over twice-nightly dosing for oxybate therapy. Post-hoc analyses from the Phase 3 REST-ON trial showed FT218 significantly improved daytime sleepiness and sleep quality. Interim data from the RESTORE trial indicated FT218 was generally well tolerated. The FDA is currently reviewing FT218's marketing application.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced that CEO Greg Divis will participate in a virtual fireside chat at the Oppenheimer 32nd Annual Healthcare Conference on March 17 at 10:40 a.m. ET. The event will be accessible via a live webcast on Avadel's Investor Relations website, along with an archived recording available for 90 days post-conference. Avadel focuses on innovative medications, with its lead drug candidate FT218 aimed at treating narcolepsy-related symptoms using proprietary drug delivery technology.
Avadel Pharmaceuticals (Nasdaq: AVDL) will present eight posters at World Sleep 2022 from March 11-16 in Rome, Italy, showcasing new data from the Phase 3 REST-ON clinical trial of FT218 and the ongoing RESTORE study. FT218 is an investigational once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness (EDS) and cataplexy in narcolepsy patients, currently under FDA review. The company will also support a Satellite Symposium addressing patient needs in narcolepsy treatment.
Avadel Pharmaceuticals (Nasdaq: AVDL) has appointed Douglas Williamson as the new Chief Medical Officer. With over 25 years of experience in the biopharmaceutical industry, Williamson's expertise in R&D and clinical development, particularly in neuroscience, is expected to be instrumental in advancing the company's lead candidate, FT218, for narcolepsy treatment. In recognition of his hiring, the Compensation Committee granted him options to purchase 275,000 shares at $6.60 each, with a four-year vesting schedule. This strategic move is seen as pivotal for Avadel's growth.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced that CEO Greg Divis will join a fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on February 17, 2022, at 1:40 p.m. ET. A live webcast and an archived recording will be available on the company’s Investor Relations website for 90 days post-conference.
Avadel focuses on transforming medicines, with its lead drug candidate, FT218, aimed at treating excessive daytime sleepiness and cataplexy in adults with narcolepsy.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced that CEO Greg Divis will participate in two upcoming investor conferences. The Piper Sandler 33rd Annual Virtual Healthcare Conference will feature a fireside chat starting on November 29, with an on-demand viewing available from November 22. The Evercore ISI 4th Annual HealthCONx Conference will include a fireside chat on December 1 at 2:00 p.m. ET. Webcasts and recordings of these events will be accessible on Avadel’s Investor Relations website for 90 days post-conference.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced CEO Greg Divis's participation in two upcoming investor conferences in November 2021:
- Stifel’s 2021 Virtual Healthcare Conference on November 16 at 8:00 a.m. E.T.
- Jefferies London Healthcare Conference available on demand starting November 18 at 3:00 a.m. E.T.
A webcast and archived recordings will be on Avadel's Investor Relations website for 90 days post-conference. Avadel focuses on innovative medications, notably the investigational drug candidate FT218 for treating narcolepsy.
Avadel Pharmaceuticals (Nasdaq: AVDL) provided an update on its ongoing FDA review of the NDA for FT218, a novel treatment for narcolepsy. The company highlighted advancements in commercial preparations and the presentation of new clinical data from the REST-ON trial, showing significant improvements in cataplexy attacks and excessive daytime sleepiness (EDS). For Q3 2021, net loss was $22 million, or $0.38 per diluted share, with cash reserves at $181.1 million. The commercial team expansion and positive payor discussions reflect strong market entry plans if approved.
Avadel Pharmaceuticals (Nasdaq: AVDL) will host a conference call on November 8, 2021, at 8:30 a.m. ET to discuss its third-quarter financial results for the period ending September 30, 2021. Investors can join by dialing (844) 388-0559 in the U.S. or (216) 562-0393 internationally, using conference ID 6187211. A live audio webcast will be available on Avadel's investor relations website, with a replay accessible for 90 days. The company focuses on developing innovative medications, notably its lead candidate FT218 for narcolepsy.
Avadel Pharmaceuticals announced promising results from the Phase 3 REST-ON clinical trial of its once-nightly treatment FT218 for narcolepsy, highlighting significant reductions in weekly cataplexy attacks and improved sleep latency when compared to placebo. Presented at the CHEST annual meeting, key findings revealed that a notable percentage of patients experienced a substantial decrease in cataplexy episodes. A discrete choice experiment indicated that once-nightly dosing is preferred by patients over twice-nightly dosing. FT218 is currently under FDA review, and if approved, may represent a vital treatment option.
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