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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.
DUBLIN, Ireland, May 25, 2021 – Avadel Pharmaceuticals (Nasdaq: AVDL) announced that CEO Greg Divis will participate in a fireside chat on June 1 at 9:00 a.m. ET. This event will focus on FT218, an investigational once-nightly formulation of sodium oxybate aimed at treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. A live webcast and an archived recording will be accessible on Avadel’s Investor Relations website for 90 days following the conference.
Avadel Pharmaceuticals announced that the FDA accepted the NDA for once-nightly FT218, targeting a PDUFA date of October 15, 2021. Positive secondary endpoint data from the REST-ON trial was presented at the AAN 2021 Annual Meeting, indicating FT218's efficacy in improving sleep quality for narcolepsy patients. The company reported no revenue for Q1 2021, down from $12.2 million in Q1 2020, with a net loss of $13.4 million, or ($0.23) per share. However, cash reserves stand at $205 million, positioning the company well for upcoming developments.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) has announced a conference call on May 10, 2021, at 8:30 a.m. ET to discuss its financial results for Q1 2021, ending March 31, 2021. The call will provide updates on the company’s progress, particularly focusing on FT218, a sodium oxybate formulation intended for treating narcolepsy symptoms. Investors can join via dial-in or listen to a live webcast from the investor relations section of Avadel's website, with a replay available for 90 days.
Avadel Pharmaceuticals (Nasdaq: AVDL) presented positive secondary endpoint data for FT218 at the 2021 AAN Meeting. The investigational once-nightly formulation of sodium oxybate showed significant improvements at doses of 6 g, 7.5 g, and 9 g in treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. Results demonstrated clinically meaningful enhancements in sleep quality, arousals, and nocturnal sleep disturbances, with a PDUFA target action date set for October 15, 2021, for FDA review.
Avadel Pharmaceuticals (Nasdaq: AVDL) is set to present new secondary endpoint data from its pivotal REST-ON Phase 3 trial of FT218, a once-nightly sodium oxybate formulation, at the 2021 American Academy of Neurology Annual Meeting from April 17-22. Key poster presentations include polysomnographic measures of sleep continuity and the impact of daytime sleepiness, sleep quality, hallucinations, and sleep paralysis in narcolepsy patients. FT218, aimed at treating excessive daytime sleepiness and cataplexy, received FDA's Orphan Drug Designation and has a PDUFA target date of October 15, 2021.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) will participate in a fireside chat at Stifel's Third Annual CNS Day on March 31 at 3 p.m. ET. The discussion will focus on FT218, an investigational formulation of sodium oxybate aimed at treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. A live webcast will be available for attendees, along with a recording accessible for 90 days on the company’s website.
Avadel Pharmaceuticals (AVDL) announced the FDA's acceptance of its New Drug Application for FT218, aimed at treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. The PDUFA target action date is set for October 15, 2021. In preparation for the product launch, key appointments were made in Commercial and Clinical Affairs. The company reported no revenue for Q4 2020, with a net loss of $11.3 million, compared to a loss of $2.7 million in Q4 2019. Cash reserves stand at $221.4 million, indicating ample liquidity for upcoming initiatives.
Avadel Pharmaceuticals (Nasdaq: AVDL) announces a collaboration with the AASM Foundation to support the 2021 Young Investigators Research Forum, providing scholarships and training for 24 early career sleep researchers. This program enhances career development in sleep medicine, offering crucial skills in funding and research processes. Avadel aims to bolster research in sleep health, particularly for conditions like narcolepsy. The initiative reflects Avadel's commitment to advancing sleep medicine and investing in the future of sleep research.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced the online publication of four Phase 1 studies regarding FT218, a once-nightly formulation of sodium oxybate aimed at treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. The studies, published in Clinical Therapeutics, demonstrated bioequivalent drug exposure and a favorable pharmacokinetic profile supporting once-nightly dosing. FT218 was previously granted FDA Orphan Drug Designation, and the New Drug Application (NDA) was accepted for filing on February 26, 2021, with a target action date of October 15, 2021.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced the FDA has accepted its New Drug Application (NDA) for FT218, a once-nightly sodium oxybate formulation for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy. The FDA assigned a PDUFA target action date of October 15, 2021. FT218, which received Orphan Drug Designation, may offer clinical advantages over the existing twice-nightly formulation. The NDA is backed by positive results from the Phase 3 REST-ON study, with further data expected at upcoming conferences.
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