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 (AVDL) is a leading biopharmaceutical company focused on developing transformative therapies for sleep disorders and urological conditions. This page serves as the definitive source for official company announcements, clinical trial updates, and regulatory developments.
Investors and healthcare professionals will find timely updates on Avadel's innovative once-at-bedtime treatments, including its FDA-approved therapy for narcolepsy. Our news collection covers essential developments in drug formulation advancements, partnership announcements, and market expansion strategies.
Key content areas include:
Regulatory milestones - Track FDA approvals and designations
Clinical research - Updates on studies like the REST-ON trial
Therapeutic innovations - Developments in sleep medicine and urology
Corporate strategy - Partnerships and commercial initiatives
Bookmark this page for direct access to verified information about Avadel's progress in simplifying treatment regimens through its proprietary drug delivery technologies. Check regularly for updates that matter to stakeholders in specialty pharmaceuticals.
Avadel Pharmaceuticals (Nasdaq: AVDL) unveiled new data at the ANA annual meeting regarding narcolepsy patients, revealing a higher occurrence of mood, sleep, and pain disorders among those affected. The analysis, involving over 2,000 patients, highlighted significant comorbidities such as restless leg syndrome and chronic pain. Furthermore, positive results from the Phase 3 REST-ON trial for LUMRYZ, a once-nightly sodium oxybate treatment, were reaffirmed, showing patient preference for this regimen. With FDA approval pending, Avadel aims to reshape narcolepsy treatment.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced that its management will participate in a fireside chat at the Ladenburg Thalmann Healthcare Conference on September 29, 2022, at 12:30 p.m. E.T. A live webcast and an archived recording will be available on Avadel’s Investor Relations website for 90 days post-conference.
The company focuses on transforming medicines, with its lead drug candidate, LUMRYZ™, a sodium oxybate formulation designed for narcolepsy treatment.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) will participate in a fireside chat at the H.C. Wainwright Global Investment Conference on September 14 at 11:30 a.m. E.T. The discussion will focus on the company's innovative approaches to medicine, notably their lead drug candidate, LUMRYZ™, which is designed for the treatment of cataplexy and excessive daytime sleepiness in adults with narcolepsy. Investors can access a live webcast and archived recording on the Investor Relations website.
Avadel Pharmaceuticals (AVDL) announced tentative FDA approval for LUMRYZ (sodium oxybate) on July 18, 2022, signaling progress towards final approval, expected by June 2023. The company is pursuing legal actions to expedite approval, including a lawsuit against the FDA and delisting a REMS patent. Financial results for Q2 revealed a net loss of $63.4 million, an increase from $19.6 million a year prior. Cash reserves stand at $104.1 million, with plans to reduce cash operating expenses to $12-$14 million per quarter.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced a conference call on August 9, 2022, at 8:00 a.m. ET to discuss its corporate update and financial results for Q2 2022, which ended on June 30. Investors can join the call by dialing (833) 630-0586 (U.S.) or (412) 317-1827 (International). A live audio webcast will also be available on the company's investor relations website, with a replay archived for 90 days. Avadel focuses on innovative drug solutions, with LUMRYZ, an investigational sodium oxybate formulation for narcolepsy, as its lead candidate.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced that the FDA has granted tentative approval for LUMRYZ (FT218), a once-at-bedtime formulation of sodium oxybate for treating excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy. This approval confirms LUMRYZ’s clinical efficacy and safety. The company estimates a total patient population exceeding 30,000 and a potential market opportunity of over $3 billion annually. Avadel is pursuing strategies to accelerate final approval, which is expected by June 2023.
Avadel Pharmaceuticals (Nasdaq: AVDL) is actively pursuing pathways for the FDA to grant final approval for its drug candidate FT218 before June 2023. The company has reached a final label agreement, and efforts are underway to complete the Risk Evaluation and Mitigation Strategy (REMS). FT218 targets the multi-billion-dollar narcolepsy market and is expected to serve up to 35,000 patients. Avadel plans to optimize costs to extend its cash runway, aiming for reduced quarterly cash operating expenses of $12-14 million, with over $100 million in cash reserves as of June 30, 2022.
Velan Capital Investment Management and Repertoire Partners, owning approximately 7.7% of Radius Health, Inc. (RDUS), filed a proxy statement for the election of their nominees, Eric Ende, Cynthia Flowers, and Ann MacDougall, to the Board. They criticize the current Board for value destruction, poor governance, and mismanagement. Velan-Repertoire argues that substantial change is essential to unlock the company's potential and urges shareholders to vote for their nominees at the July 8, 2022 Annual Meeting.
Avadel Pharmaceuticals (Nasdaq: AVDL) has entered an exclusive collaboration with the AASM Foundation to support the 2022 Young Investigators Research Forum (YIRF), which offers scholarships and training for early career sleep researchers. This initiative, ongoing since 2009, aims to enhance skills in sleep research and funding opportunities. The partnership highlights Avadel's commitment to advancing sleep science, which is critical for health, especially in conditions like narcolepsy. The forum will engage participants at the upcoming SLEEP 2022 conference in June.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced that CEO Greg Divis and CFO Tom McHugh will participate in a fireside chat at the Jefferies Healthcare Conference on June 9 at 4:00 p.m. E.T.
The event will be available via live webcast and archived for 90 days on Avadel’s Investor Relations website. The company focuses on transforming medicines, with its lead drug candidate FT218, a once-nightly formulation for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy.