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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 (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.
Avadel Pharmaceuticals (NASDAQ: AVDL) announced a conference call on August 9, 2021, at 8:30 a.m. ET to discuss its second-quarter financial results for 2021. The company is focusing on developing FT218, a once-nightly formulation of sodium oxybate aimed at treating excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy. Investors can participate through a dedicated phone line or via a live webcast on the company’s website.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced that its CEO, Greg Divis, will participate in a fireside chat on July 14 at 11:00 a.m. ET. The discussion will focus on FT218, an investigational treatment for excessive daytime sleepiness and cataplexy in adults with narcolepsy. A live webcast will be available on Avadel’s Investor Relations website, along with an archived recording accessible for 90 days after the event. This engagement highlights Avadel's commitment to advancing its innovative therapies.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced positive post hoc analyses from the Phase 3 REST-ON clinical trial of FT218, a once-nightly sodium oxybate formulation for narcolepsy. Data show significant improvements in excessive daytime sleepiness across narcolepsy subtypes, with substantial weight loss benefits for patients. FT218 demonstrated statistically significant efficacy at all doses evaluated, with a PDUFA date at the FDA set for October 15, 2021. The findings were presented at the SLEEP 2021 conference, highlighting FT218's potential as a transformative treatment for narcolepsy.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced it will present pivotal Phase 3 REST-ON clinical trial data for FT218 at the virtual SLEEP 2021 meeting from June 10-13, 2021. FT218, a once-nightly formulation of sodium oxybate, targets excessive daytime sleepiness and cataplexy in narcolepsy patients. The presentation includes six abstracts focusing on various efficacy and safety aspects. The FDA has accepted the NDA for FT218, aiming for a decision by October 15, 2021, and granted it Orphan Drug Designation, indicating potential clinical superiority over existing treatments.
Avadel Pharmaceuticals announces key leadership appointments to bolster its team ahead of the anticipated U.S. regulatory approval and commercialization of FT218, an investigational treatment for narcolepsy. Jeff Cruikshank joins as Vice President of Sales, Denise Strauss as Vice President of Marketing and New Product Strategy, and Angela Woods as Vice President of People and Culture. These roles are designed to enhance the company’s capabilities to support FT218’s market launch, which is expected to bring a significant impact to patients dealing with narcolepsy.
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