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 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.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced a conference call on August 10, 2020, at 8:30 a.m. ET to discuss its second-quarter financial results for the period ending June 30, 2020. Investors can access the call by dialing 877-407-9716 (U.S.) or 201-493-6779 (international), with a conference ID of 13707645. The event will be available via a live audio webcast on the company’s website, and a replay will be archived for 90 days. Avadel is focused on the development of FT218, currently in Phase 3 trials for treating narcolepsy.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced the initiation of an open-label extension/switch study for FT218, a once-nightly formulation of sodium oxybate, in patients with narcolepsy. The study aims to enroll 250 patients, assessing long-term safety, maintenance of efficacy, and patient preference for switching from twice-nightly sodium oxybate to FT218. The first patient was dosed at Florida Research Institute, marking a significant step in clinical research for narcolepsy treatment, following positive Phase 3 data from the REST-ON study.
DUBLIN, Ireland, June 08, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals (Nasdaq: AVDL) announced that CEO Greg Divis and CMO Jordan Dubow will present at BIO Digital from June 8-12, 2020. The focus will be on FT218, a once-nightly sodium oxybate formulation targeting excessive daytime sleepiness and cataplexy in narcolepsy patients. The Phase 3 Rest-On clinical trial reported positive results. The presentation will be available on-demand during the conference at this link.
Avadel Pharmaceuticals (Nasdaq: AVDL) will host a conference call on May 11, 2020, at 8:30 a.m. ET, to discuss Q1 2020 financial results and provide a corporate update. The company focuses on FT218, a once-nightly sodium oxybate formulation for narcolepsy. FT218 has completed Phase 3 trials aimed at treating excessive daytime sleepiness and cataplexy. Investors can join the call at 877-407-9716 (U.S.) or 201-493-6779 (international). A live webcast will also be available on their website.
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