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Avadel Pharmaceuticals plc was a commercial-stage biopharmaceutical company focused on sleep medicine before its acquisition by Alkermes plc. Its company updates centered on LUMRYZ, an FDA-approved sodium oxybate extended-release oral suspension for cataplexy or excessive daytime sleepiness in patients seven years of age and older with narcolepsy.
Recurring developments included LUMRYZ commercialization, clinical and regulatory disclosures for the REVITALYZ trial in idiopathic hypersomnia, operating and financial results, material agreements, shareholder voting matters, governance items and capital-structure changes tied to its public-company status and completed acquisition.
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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