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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) has submitted a New Drug Application (NDA) to the FDA for FT218, a once-nightly formulation of sodium oxybate aimed at treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. This submission marks a significant milestone for the company. If approved, FT218 could provide a valuable alternative to the existing twice-nightly treatment, potentially enhancing patient compliance and safety. The NDA follows the successful completion of the REST-ON Phase 3 trial, where FT218 demonstrated efficacy and safety, alongside Orphan Drug Designation from the FDA.
Avadel Pharmaceuticals (Nasdaq: AVDL) is set to join the NASDAQ Biotechnology Index on December 21, 2020. This index tracks biotechnology and pharmaceutical stocks and is re-ranked annually. The addition reflects AVDL's focus on FT218, an investigational once-nightly sodium oxybate formulation aimed at treating narcolepsy. The company completed a pivotal Phase 3 trial for FT218, which has received Orphan Drug Designation from the FDA, indicating potential clinical superiority over existing treatments.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) has appointed Dr. Jennifer Gudeman as Vice President, Medical and Clinical Affairs. She will oversee medical and clinical activities for the company's lead program, FT218, a once-nightly sodium oxybate formulation for narcolepsy. Dr. Gudeman brings 20 years of industry experience, including leading six product launches. The company plans to submit the New Drug Application (NDA) for FT218 to the FDA this month, aiming to address the unmet needs of sodium oxybate-eligible narcolepsy patients.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced participation in two major upcoming conferences focused on healthcare. The 32nd Annual Piper Sandler Virtual Healthcare Conference is scheduled for December 1-3, 2020, where Avadel's management will present. Additionally, they will present at the 3rd Annual Evercore ISI HealthCONx Conference on December 3, 2020, at 9:15 a.m. ET. Webcasts for both events will be available on Avadel's website and through the conference sites.
The company's primary focus remains on developing FT218, a once-nightly formulation of sodium oxybate aimed at treating narcolepsy.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced that its management team will present at the Stifel Virtual Healthcare Conference on November 16, 2020, at 9:20 a.m. ET, and the Jefferies Virtual London Healthcare Conference on November 18, 2020, at 6:45 p.m. GMT (1:45 p.m. ET). The presentations will focus on FT218, an investigational formulation of sodium oxybate aimed at treating excessive daytime sleepiness and cataplexy in narcolepsy patients. Webcasts will be accessible on the company's website and available for replay for 90 days post-presentation.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced its progress on FT218, a once-nightly formulation of sodium oxybate aimed at treating narcolepsy. The NDA submission is on track for December 2020. A recent market assessment revealed that 60% of sodium oxybate-eligible patients are not currently receiving treatment due to twice-nightly dosing issues, indicating substantial market potential. However, the company reported no revenue for Q3 2020, with a net loss of $11.7 million. Cash resources stand at $231.6 million, while convertible debt amounts to $143.8 million due in February 2023.
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.
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