Welcome to our dedicated page for Avadel Pharmaceuticals plc Ordinary Share news (Ticker: AVDL), a resource for investors and traders seeking the latest updates and insights on Avadel Pharmaceuticals plc Ordinary Share stock.
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 (Nasdaq: AVDL) will host a conference call on November 9, 2020, at 8:30 a.m. ET to discuss its Q3 2020 financial results and corporate updates. The call will provide insights into the development of FT218, a once-nightly sodium oxybate formulation for narcolepsy. Investors can access the call via phone or through a live audio webcast available on Avadel's investor relations website. A replay will be available for 90 days following the event.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) will present its investigational drug FT218 at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit from September 21-23, 2020. CEO and executives will discuss FT218, a once-nightly formulation of sodium oxybate for narcolepsy, on September 22, 2020, from 10:50 a.m. to 11:30 a.m. ET. The presentation will be webcast live and available for later viewing. Management will also engage in one-on-one meetings with registered investors.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced that Jordan Dubow, M.D. is stepping down as Chief Medical Officer, transitioning to a consultant role through the FT218 NDA submission process. Mark McCamish, M.D., Ph.D., a seasoned Board member, will take over direct leadership for the FT218 program. The company remains confident in the NDA filing timeline and the promising market potential for FT218, an investigational treatment for narcolepsy, following successful Phase 3 results. The Board and management are committed to maximizing shareholder value as they evaluate strategic options.
Avadel Pharmaceuticals (Nasdaq: AVDL) is set to present at the H.C. Wainwright 22nd Annual Global Investment Conference from September 14 to 16, 2020. The presentation will take place on September 16, 2020, from 10:30 a.m. to 10:50 a.m. ET. A live and archived webcast will be available on their website. The company is focusing on FT218, a once-nightly sodium oxybate formulation, currently undergoing trials for treating narcolepsy. FT218 has received Orphan Drug Designation from the FDA, highlighting its potential superiority over existing treatments.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced a conference call on August 10, 2020, at 8:30 a.m. ET to discuss its second-quarter financial results for the period ending June 30, 2020. Investors can access the call by dialing 877-407-9716 (U.S.) or 201-493-6779 (international), with a conference ID of 13707645. The event will be available via a live audio webcast on the company’s website, and a replay will be archived for 90 days. Avadel is focused on the development of FT218, currently in Phase 3 trials for treating narcolepsy.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced the initiation of an open-label extension/switch study for FT218, a once-nightly formulation of sodium oxybate, in patients with narcolepsy. The study aims to enroll 250 patients, assessing long-term safety, maintenance of efficacy, and patient preference for switching from twice-nightly sodium oxybate to FT218. The first patient was dosed at Florida Research Institute, marking a significant step in clinical research for narcolepsy treatment, following positive Phase 3 data from the REST-ON study.
DUBLIN, Ireland, June 08, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals (Nasdaq: AVDL) announced that CEO Greg Divis and CMO Jordan Dubow will present at BIO Digital from June 8-12, 2020. The focus will be on FT218, a once-nightly sodium oxybate formulation targeting excessive daytime sleepiness and cataplexy in narcolepsy patients. The Phase 3 Rest-On clinical trial reported positive results. The presentation will be available on-demand during the conference at this link.
Avadel Pharmaceuticals (Nasdaq: AVDL) will host a conference call on May 11, 2020, at 8:30 a.m. ET, to discuss Q1 2020 financial results and provide a corporate update. The company focuses on FT218, a once-nightly sodium oxybate formulation for narcolepsy. FT218 has completed Phase 3 trials aimed at treating excessive daytime sleepiness and cataplexy. Investors can join the call at 877-407-9716 (U.S.) or 201-493-6779 (international). A live webcast will also be available on their website.
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