Avadel Pharmaceu Stock Price, News & Analysis

Avadel Pharmaceuticals (Nasdaq: AVDL) is set to present new secondary endpoint data from its pivotal REST-ON Phase 3 trial of FT218, a once-nightly sodium oxybate formulation, at the 2021 American Academy of Neurology Annual Meeting from April 17-22. Key poster presentations include polysomnographic measures of sleep continuity and the impact of daytime sleepiness, sleep quality, hallucinations, and sleep paralysis in narcolepsy patients. FT218, aimed at treating excessive daytime sleepiness and cataplexy, received FDA's Orphan Drug Designation and has a PDUFA target date of October 15, 2021.

Avadel Pharmaceuticals plc (Nasdaq: AVDL) will participate in a fireside chat at Stifel's Third Annual CNS Day on March 31 at 3 p.m. ET. The discussion will focus on FT218, an investigational formulation of sodium oxybate aimed at treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. A live webcast will be available for attendees, along with a recording accessible for 90 days on the company’s website.

Avadel Pharmaceuticals (AVDL) announced the FDA's acceptance of its New Drug Application for FT218, aimed at treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. The PDUFA target action date is set for October 15, 2021. In preparation for the product launch, key appointments were made in Commercial and Clinical Affairs. The company reported no revenue for Q4 2020, with a net loss of $11.3 million, compared to a loss of $2.7 million in Q4 2019. Cash reserves stand at $221.4 million, indicating ample liquidity for upcoming initiatives.

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.