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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 (Nasdaq: AVDL) announced that the FDA has granted tentative approval for LUMRYZ (FT218), a once-at-bedtime formulation of sodium oxybate for treating excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy. This approval confirms LUMRYZ’s clinical efficacy and safety. The company estimates a total patient population exceeding 30,000 and a potential market opportunity of over $3 billion annually. Avadel is pursuing strategies to accelerate final approval, which is expected by June 2023.
Avadel Pharmaceuticals (Nasdaq: AVDL) is actively pursuing pathways for the FDA to grant final approval for its drug candidate FT218 before June 2023. The company has reached a final label agreement, and efforts are underway to complete the Risk Evaluation and Mitigation Strategy (REMS). FT218 targets the multi-billion-dollar narcolepsy market and is expected to serve up to 35,000 patients. Avadel plans to optimize costs to extend its cash runway, aiming for reduced quarterly cash operating expenses of $12-14 million, with over $100 million in cash reserves as of June 30, 2022.
Velan Capital Investment Management and Repertoire Partners, owning approximately 7.7% of Radius Health, Inc. (RDUS), filed a proxy statement for the election of their nominees, Eric Ende, Cynthia Flowers, and Ann MacDougall, to the Board. They criticize the current Board for value destruction, poor governance, and mismanagement. Velan-Repertoire argues that substantial change is essential to unlock the company's potential and urges shareholders to vote for their nominees at the July 8, 2022 Annual Meeting.
Avadel Pharmaceuticals (Nasdaq: AVDL) has entered an exclusive collaboration with the AASM Foundation to support the 2022 Young Investigators Research Forum (YIRF), which offers scholarships and training for early career sleep researchers. This initiative, ongoing since 2009, aims to enhance skills in sleep research and funding opportunities. The partnership highlights Avadel's commitment to advancing sleep science, which is critical for health, especially in conditions like narcolepsy. The forum will engage participants at the upcoming SLEEP 2022 conference in June.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced that CEO Greg Divis and CFO Tom McHugh will participate in a fireside chat at the Jefferies Healthcare Conference on June 9 at 4:00 p.m. E.T.
The event will be available via live webcast and archived for 90 days on Avadel’s Investor Relations website. The company focuses on transforming medicines, with its lead drug candidate FT218, a once-nightly formulation for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced the presentation of clinical data for FT218 at the 36th Annual Meeting of the Associated Professional Sleep Societies from June 4-8, 2022. FT218 is an investigational sodium oxybate formulation aimed at treating excessive daytime sleepiness and cataplexy in narcolepsy patients. The presentations will include interim data from the RESTORE study, highlighting dosing and patient preferences. FT218 has shown promising results in prior trials, and an FDA marketing application is currently under review.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) has announced that CEO Greg Divis will participate in a fireside chat at the H.C. Wainwright Global Investment Conference on May 25 at 8:30 a.m. E.T. This event aims to share insights into the company's innovative biopharmaceutical solutions. A live webcast and an archived recording will be available on the company's Investor Relations website for 90 days following the conference. Avadel focuses on developing medications for challenges faced by patients, notably their lead candidate, FT218, designed for narcolepsy treatment.
Avadel Pharmaceuticals provided an update on the FDA review of its NDA for FT218, aimed at managing narcolepsy symptoms. The FDA has no outstanding questions regarding the application, paving the way for a potential commercial launch. Interim results from the RESTORE study showed a significant patient preference for FT218's once-at-bedtime dosage over the twice-nightly regimen, with 94.3% of participants expressing a preference. The company's financial results indicated a net loss of $26.4 million for Q1 2022, up from $13.4 million in 2021, alongside increased R&D and SG&A expenses.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced a conference call on May 9, 2022, at 8:30 a.m. ET to discuss Q1 financial results ending March 31, 2022. Investors can join the call by dialing (844) 388-0559 (U.S. and Canada) or (216) 562-0393 (International), using conference ID 8183841. The call will also be available via a live webcast on the company's investor relations site, with an archived replay for 90 days. Avadel focuses on innovative treatments, notably its lead drug candidate FT218 for narcolepsy-related symptoms.
Avadel Pharmaceuticals (Nasdaq: AVDL) addressed recent trading volatility and a brief trading halt of its shares, clarifying that no new information regarding the FT218 NDA review has surfaced. CEO Greg Divis emphasized ongoing launch preparations for FT218, a sodium oxybate formulation aimed at treating narcolepsy. The FDA granted FT218 Orphan Drug Designation in 2018 due to its potential safety advantages. Avadel aims to improve narcolepsy treatment with this investigational agent, which demonstrated significant results in Phase 3 trials.
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