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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 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.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced interim results from its RESTORE study at the 2022 AAN Meeting. The study evaluated patient preferences regarding FT218, a once-nightly formulation of sodium oxybate for narcolepsy. Findings revealed 94.3% (33/35) of participants preferred FT218 over the twice-nightly dosing regimen. Additionally, nocturnal adverse events highlighted issues with the second dose, with 63% of participants missing it, causing worsened symptoms. FT218 has the potential to significantly ease the burden on narcolepsy patients if approved.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced positive secondary endpoint results from its Phase 3 REST-ON trial of FT218, an investigational sodium oxybate formulation for narcolepsy. Published in CNS Drugs, the data demonstrate FT218's ability to improve nighttime sleep disruptions significantly compared to placebo. Key findings show FT218 led to fewer nocturnal arousals and improved sleep quality across various doses. The trial supports FT218's potential as an effective treatment for excessive daytime sleepiness and cataplexy, with a marketing application currently under review by the FDA.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced that CEO Greg Divis will participate in two upcoming investor conferences. The first is the Stifel 2022 Virtual CNS Day on March 29 at 12:00 p.m. E.T., followed by the 21st Annual Needham Virtual Healthcare Conference on April 11 at 2:15 p.m. E.T. Live webcasts and archived recordings will be accessible on Avadel's Investor Relations website for 90 days post-conference. Avadel focuses on innovative medications like FT218, aimed at treating narcolepsy symptoms.
Avadel Pharmaceuticals (Nasdaq: AVDL) provided a corporate update, emphasizing ongoing FDA review for FT218, a treatment for narcolepsy. Key highlights include multiple presentations at World Sleep 2022 showcasing FT218's effectiveness, and the extension of $117.4 million convertible notes maturity to October 2023. Additionally, net loss for Q4 2021 was $22.3 million, worsening from $11.3 million in Q4 2020. R&D expenses decreased to $2.1 million, while SG&A expenses surged to $21.0 million. The company remains focused on potential commercialization of FT218, pending FDA approval.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced the appointment of Brandi Robinson as Senior Vice President of Corporate Affairs, aimed at strengthening its operational and commercial infrastructure. Robinson, with over 25 years of experience in the biopharmaceutical industry, will support the upcoming launch of FT218, designed to treat narcolepsy symptoms. The transition includes a grant of 215,000 stock options at an exercise price of $7.22 per share, aligning her interests with the company's goals.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) will host a conference call on March 17, 2022, at 8:30 a.m. ET to provide a corporate update and discuss financial results for Q4 and the full year ended December 31, 2021. Investors can join via phone or through a live webcast on Avadel’s website, which will be available for replay for 90 days. The company focuses on innovative medication solutions, particularly its investigational drug candidate FT218 aimed at treating narcolepsy-related excessive daytime sleepiness and cataplexy.
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