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.
This page contains historical news coverage for Avadel Pharmaceuticals plc (AVDL), which operated as a specialty pharmaceutical company focused on sleep disorders and central nervous system therapeutics. The company was acquired by Lundbeck, combining its sleep medicine portfolio with Lundbeck's neuroscience franchise. This archive provides context on Avadel's business development, clinical programs, and the events surrounding its acquisition.
Avadel's news flow typically centered on clinical trial progress, regulatory submissions, and commercial developments related to its sleep disorder treatments. As a specialty pharmaceutical company, the company's announcements often addressed product development milestones, partnership agreements, and financial performance tied to its CNS-focused therapeutic pipeline. Understanding this historical coverage offers insight into the company's strategic priorities and market positioning before its acquisition.
The archived news includes quarterly earnings reports, regulatory updates, clinical data presentations, and corporate development announcements. For investors researching the sleep medicine sector or tracking pharmaceutical acquisitions, this historical record documents Avadel's evolution as an independent specialty pharma company and the circumstances leading to its combination with Lundbeck. Those seeking current information about Avadel's former product portfolio should reference Lundbeck's disclosures regarding its sleep disorder franchise.
Avadel Pharmaceuticals (Nasdaq: AVDL) is set to join the NASDAQ Biotechnology Index on December 21, 2020. This index tracks biotechnology and pharmaceutical stocks and is re-ranked annually. The addition reflects AVDL's focus on FT218, an investigational once-nightly sodium oxybate formulation aimed at treating narcolepsy. The company completed a pivotal Phase 3 trial for FT218, which has received Orphan Drug Designation from the FDA, indicating potential clinical superiority over existing treatments.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) has appointed Dr. Jennifer Gudeman as Vice President, Medical and Clinical Affairs. She will oversee medical and clinical activities for the company's lead program, FT218, a once-nightly sodium oxybate formulation for narcolepsy. Dr. Gudeman brings 20 years of industry experience, including leading six product launches. The company plans to submit the New Drug Application (NDA) for FT218 to the FDA this month, aiming to address the unmet needs of sodium oxybate-eligible narcolepsy patients.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced participation in two major upcoming conferences focused on healthcare. The 32nd Annual Piper Sandler Virtual Healthcare Conference is scheduled for December 1-3, 2020, where Avadel's management will present. Additionally, they will present at the 3rd Annual Evercore ISI HealthCONx Conference on December 3, 2020, at 9:15 a.m. ET. Webcasts for both events will be available on Avadel's website and through the conference sites.
The company's primary focus remains on developing FT218, a once-nightly formulation of sodium oxybate aimed at treating narcolepsy.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced that its management team will present at the Stifel Virtual Healthcare Conference on November 16, 2020, at 9:20 a.m. ET, and the Jefferies Virtual London Healthcare Conference on November 18, 2020, at 6:45 p.m. GMT (1:45 p.m. ET). The presentations will focus on FT218, an investigational formulation of sodium oxybate aimed at treating excessive daytime sleepiness and cataplexy in narcolepsy patients. Webcasts will be accessible on the company's website and available for replay for 90 days post-presentation.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced its progress on FT218, a once-nightly formulation of sodium oxybate aimed at treating narcolepsy. The NDA submission is on track for December 2020. A recent market assessment revealed that 60% of sodium oxybate-eligible patients are not currently receiving treatment due to twice-nightly dosing issues, indicating substantial market potential. However, the company reported no revenue for Q3 2020, with a net loss of $11.7 million. Cash resources stand at $231.6 million, while convertible debt amounts to $143.8 million due in February 2023.
Avadel Pharmaceuticals (Nasdaq: AVDL) will host a conference call on November 9, 2020, at 8:30 a.m. ET to discuss its Q3 2020 financial results and corporate updates. The call will provide insights into the development of FT218, a once-nightly sodium oxybate formulation for narcolepsy. Investors can access the call via phone or through a live audio webcast available on Avadel's investor relations website. A replay will be available for 90 days following the event.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) will present its investigational drug FT218 at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit from September 21-23, 2020. CEO and executives will discuss FT218, a once-nightly formulation of sodium oxybate for narcolepsy, on September 22, 2020, from 10:50 a.m. to 11:30 a.m. ET. The presentation will be webcast live and available for later viewing. Management will also engage in one-on-one meetings with registered investors.
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.
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