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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 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.
Avadel Pharmaceuticals (AVDL) announced that the FDA's review of its New Drug Application for FT218 is ongoing, with no action expected in October. The FDA confirmed receipt of all necessary information, and no deficiencies have been reported. FT218 aims to treat excessive daytime sleepiness and cataplexy in narcolepsy patients, delivering positive results in its Phase 3 REST-ON study. The FDA previously granted FT218 Orphan Drug Designation, indicating the potential for clinical superiority over existing treatments. Avadel remains committed to patient access to FT218 as swiftly as possible.
Avadel Pharmaceuticals (Nasdaq: AVDL) supports World Narcolepsy Day on September 22, highlighting the importance of awareness for this chronic condition affecting approximately three million people globally. Their investigational drug candidate, FT218, designed to treat excessive daytime sleepiness and cataplexy in narcolepsy, is under FDA review with a target decision date of October 15, 2021. The company emphasizes its commitment to improving treatment and addressing the stigma faced by those with narcolepsy through educational initiatives and participation in relevant medical conferences.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced that CEO Greg Divis will speak at several virtual investor conferences in September 2021. Key events include the Morgan Stanley 19th Annual Global Healthcare Conference on September 9, Wells Fargo Virtual Healthcare Conference on September 10, H.C. Wainwright’s 23rd Annual Global Investment Conference on September 13, and Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22. Live webcasts and recordings will be available for 90 days post-conference on the company's Investor Relations website.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced the publication of pivotal Phase 3 REST-ON trial data for FT218, an investigational sodium oxybate formulation, in the journal SLEEP. The study showed FT218's effectiveness in treating excessive daytime sleepiness and cataplexy in narcolepsy patients. With the FDA's Prescription Drug User Fee Act (PDUFA) target date set for October 15, 2021, the company expresses confidence in FT218's potential to transform narcolepsy treatment.
Avadel Pharmaceuticals reported significant progress in the second quarter of 2021, focusing on the potential FDA approval of FT218 for narcolepsy treatment. The New Drug Application for FT218 was accepted, with a PDUFA date set for October 15, 2021. Despite no revenue for Q2 2021 due to a previous product sale, R&D expenses rose to $6.8 million, driven by pre-launch activities. The net loss was $19.6 million, or $0.33 per diluted share. Cash reserves stood at $202.8 million, aiding the company's preparations for commercialization.
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