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) announced the appointment of Richard Kim as Chief Commercial Officer to spearhead the U.S. launch of FT218, a once-nightly sodium oxybate formulation. With over 25 years of experience in biopharmaceuticals, Kim's role is pivotal as the company prepares for FT218's regulatory approval. The NDA was submitted to the FDA, and FT218 promises to be a potentially significant advancement in narcolepsy treatment. The company's leadership emphasizes the strategy to create shareholder value through this expected commercial launch.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced its participation in the 10th Annual SVB Leerink Global Healthcare Conference from February 24-26, 2021. The management team will join a fireside chat on February 24 at 3:40 p.m. ET. A live webcast will be available for viewing on Avadel's website and will remain accessible for 90 days. The company is focused on FT218, an investigational sodium oxybate formulation aimed at treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, and has submitted a New Drug Application to the FDA.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) has submitted a New Drug Application (NDA) to the FDA for FT218, a once-nightly formulation of sodium oxybate aimed at treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. This submission marks a significant milestone for the company. If approved, FT218 could provide a valuable alternative to the existing twice-nightly treatment, potentially enhancing patient compliance and safety. The NDA follows the successful completion of the REST-ON Phase 3 trial, where FT218 demonstrated efficacy and safety, alongside Orphan Drug Designation from the FDA.
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.
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