Avadel Pharmaceu Stock Price, News & Analysis

Avadel Pharmaceuticals (Nasdaq: AVDL) announces a collaboration with the AASM Foundation to support the 2021 Young Investigators Research Forum, providing scholarships and training for 24 early career sleep researchers. This program enhances career development in sleep medicine, offering crucial skills in funding and research processes. Avadel aims to bolster research in sleep health, particularly for conditions like narcolepsy. The initiative reflects Avadel's commitment to advancing sleep medicine and investing in the future of sleep research.

Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced the online publication of four Phase 1 studies regarding FT218, a once-nightly formulation of sodium oxybate aimed at treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. The studies, published in Clinical Therapeutics, demonstrated bioequivalent drug exposure and a favorable pharmacokinetic profile supporting once-nightly dosing. FT218 was previously granted FDA Orphan Drug Designation, and the New Drug Application (NDA) was accepted for filing on February 26, 2021, with a target action date of October 15, 2021.

Avadel Pharmaceuticals (Nasdaq: AVDL) announced the FDA has accepted its New Drug Application (NDA) for FT218, a once-nightly sodium oxybate formulation for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy. The FDA assigned a PDUFA target action date of October 15, 2021. FT218, which received Orphan Drug Designation, may offer clinical advantages over the existing twice-nightly formulation. The NDA is backed by positive results from the Phase 3 REST-ON study, with further data expected at upcoming conferences.

Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced participation in fireside chats at the H.C. Wainwright Global Life Sciences Conference on March 9, 2021 and the Oppenheimer 31st Annual Healthcare Conference on March 17, 2021. The management team will discuss the company's investigational drug, FT218, a once-nightly formulation of sodium oxybate for treating narcolepsy-related symptoms. Webcasts of these events will be available on the company's website for 90 days following the presentations.

Avadel Pharmaceuticals (Nasdaq: AVDL) will host a conference call on March 9, 2021, at 8:30 a.m. ET to discuss its financial results for Q4 and FY 2020. The company focuses on developing FT218, a once-nightly formulation of sodium oxybate for treating narcolepsy. Investors can access the call at (877) 407-9716 for the U.S. and Canada or (201) 493-6779 internationally, with conference ID 13716363. A live audio webcast will be available on the company’s website, accessible for replay for 90 days post-event.

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.