Welcome to our dedicated page for Avadel Pharmaceu news (Ticker: AVDL), a resource for investors and traders seeking the latest updates and insights on Avadel Pharmaceu stock.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company whose news flow centers on its sleep medicine franchise, led by LUMRYZ, and on significant corporate transactions. Company announcements repeatedly describe Avadel as focused on transforming medicines to transform lives, with a commercial emphasis on LUMRYZ, an FDA-approved, once-at-bedtime extended-release sodium oxybate for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years and older with narcolepsy.
News updates for AVDL commonly include clinical and regulatory milestones for LUMRYZ. Examples from recent press releases include completion of enrollment in REVITALYZ, a Phase 3 trial evaluating once-at-bedtime LUMRYZ as a potential treatment for idiopathic hypersomnia, and presentation of real-world REFRESH study data in narcolepsy. These items provide insight into Avadel’s efforts to expand the clinical evidence base and explore additional indications for its lead product, while clearly noting that LUMRYZ is only approved for narcolepsy.
Investors following AVDL news will also see frequent coverage of transaction-related developments. Avadel has announced a definitive agreement under which Alkermes plc will acquire the company via an Irish High Court–sanctioned scheme of arrangement, subsequent amendments to increase the offer, and shareholder approvals of the scheme. Additional news has covered an unsolicited proposal from H. Lundbeck A/S, the Avadel board’s evaluation of that proposal, and the board’s conclusions under the Irish Takeover Rules and the Alkermes Transaction Agreement.
Other recurring news themes include licensing and legal developments, such as Avadel’s exclusive global license for valiloxybate from XWPharma and a global settlement and license agreement with Jazz Pharmaceuticals relating to LUMRYZ and Jazz’s oxybate products. Together, these updates give readers a view into AVDL’s clinical pipeline, commercial performance, strategic partnerships and the progress of the Alkermes acquisition. For ongoing context on AVDL stock, this news page aggregates these company-issued announcements and related regulatory disclosures.
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.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced new findings at World Sleep 2022 regarding its lead drug candidate, FT218, an investigational formulation of sodium oxybate for narcolepsy. A discrete choice experiment revealed that patients and clinicians prefer once-nightly dosing over twice-nightly dosing for oxybate therapy. Post-hoc analyses from the Phase 3 REST-ON trial showed FT218 significantly improved daytime sleepiness and sleep quality. Interim data from the RESTORE trial indicated FT218 was generally well tolerated. The FDA is currently reviewing FT218's marketing application.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced that CEO Greg Divis will participate in a virtual fireside chat at the Oppenheimer 32nd Annual Healthcare Conference on March 17 at 10:40 a.m. ET. The event will be accessible via a live webcast on Avadel's Investor Relations website, along with an archived recording available for 90 days post-conference. Avadel focuses on innovative medications, with its lead drug candidate FT218 aimed at treating narcolepsy-related symptoms using proprietary drug delivery technology.
FAQ
What is the current stock price of Avadel Pharmaceu (AVDL)?
What is the market cap of Avadel Pharmaceu (AVDL)?
