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 (Nasdaq: AVDL) is a biopharmaceutical company whose news flow centers on its sleep medicine franchise, led by LUMRYZ, and on significant corporate transactions. Company announcements repeatedly describe Avadel as focused on transforming medicines to transform lives, with a commercial emphasis on LUMRYZ, an FDA-approved, once-at-bedtime extended-release sodium oxybate for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years and older with narcolepsy.
News updates for AVDL commonly include clinical and regulatory milestones for LUMRYZ. Examples from recent press releases include completion of enrollment in REVITALYZ, a Phase 3 trial evaluating once-at-bedtime LUMRYZ as a potential treatment for idiopathic hypersomnia, and presentation of real-world REFRESH study data in narcolepsy. These items provide insight into Avadel’s efforts to expand the clinical evidence base and explore additional indications for its lead product, while clearly noting that LUMRYZ is only approved for narcolepsy.
Investors following AVDL news will also see frequent coverage of transaction-related developments. Avadel has announced a definitive agreement under which Alkermes plc will acquire the company via an Irish High Court–sanctioned scheme of arrangement, subsequent amendments to increase the offer, and shareholder approvals of the scheme. Additional news has covered an unsolicited proposal from H. Lundbeck A/S, the Avadel board’s evaluation of that proposal, and the board’s conclusions under the Irish Takeover Rules and the Alkermes Transaction Agreement.
Other recurring news themes include licensing and legal developments, such as Avadel’s exclusive global license for valiloxybate from XWPharma and a global settlement and license agreement with Jazz Pharmaceuticals relating to LUMRYZ and Jazz’s oxybate products. Together, these updates give readers a view into AVDL’s clinical pipeline, commercial performance, strategic partnerships and the progress of the Alkermes acquisition. For ongoing context on AVDL stock, this news page aggregates these company-issued announcements and related regulatory disclosures.
Avadel Pharmaceuticals (Nasdaq: AVDL) will present eight posters at World Sleep 2022 from March 11-16 in Rome, Italy, showcasing new data from the Phase 3 REST-ON clinical trial of FT218 and the ongoing RESTORE study. FT218 is an investigational once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness (EDS) and cataplexy in narcolepsy patients, currently under FDA review. The company will also support a Satellite Symposium addressing patient needs in narcolepsy treatment.
Avadel Pharmaceuticals (Nasdaq: AVDL) has appointed Douglas Williamson as the new Chief Medical Officer. With over 25 years of experience in the biopharmaceutical industry, Williamson's expertise in R&D and clinical development, particularly in neuroscience, is expected to be instrumental in advancing the company's lead candidate, FT218, for narcolepsy treatment. In recognition of his hiring, the Compensation Committee granted him options to purchase 275,000 shares at $6.60 each, with a four-year vesting schedule. This strategic move is seen as pivotal for Avadel's growth.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced that CEO Greg Divis will join a fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on February 17, 2022, at 1:40 p.m. ET. A live webcast and an archived recording will be available on the company’s Investor Relations website for 90 days post-conference.
Avadel focuses on transforming medicines, with its lead drug candidate, FT218, aimed at treating excessive daytime sleepiness and cataplexy in adults with narcolepsy.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced that CEO Greg Divis will participate in two upcoming investor conferences. The Piper Sandler 33rd Annual Virtual Healthcare Conference will feature a fireside chat starting on November 29, with an on-demand viewing available from November 22. The Evercore ISI 4th Annual HealthCONx Conference will include a fireside chat on December 1 at 2:00 p.m. ET. Webcasts and recordings of these events will be accessible on Avadel’s Investor Relations website for 90 days post-conference.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced CEO Greg Divis's participation in two upcoming investor conferences in November 2021:
- Stifel’s 2021 Virtual Healthcare Conference on November 16 at 8:00 a.m. E.T.
- Jefferies London Healthcare Conference available on demand starting November 18 at 3:00 a.m. E.T.
A webcast and archived recordings will be on Avadel's Investor Relations website for 90 days post-conference. Avadel focuses on innovative medications, notably the investigational drug candidate FT218 for treating narcolepsy.
Avadel Pharmaceuticals (Nasdaq: AVDL) provided an update on its ongoing FDA review of the NDA for FT218, a novel treatment for narcolepsy. The company highlighted advancements in commercial preparations and the presentation of new clinical data from the REST-ON trial, showing significant improvements in cataplexy attacks and excessive daytime sleepiness (EDS). For Q3 2021, net loss was $22 million, or $0.38 per diluted share, with cash reserves at $181.1 million. The commercial team expansion and positive payor discussions reflect strong market entry plans if approved.
Avadel Pharmaceuticals (Nasdaq: AVDL) will host a conference call on November 8, 2021, at 8:30 a.m. ET to discuss its third-quarter financial results for the period ending September 30, 2021. Investors can join by dialing (844) 388-0559 in the U.S. or (216) 562-0393 internationally, using conference ID 6187211. A live audio webcast will be available on Avadel's investor relations website, with a replay accessible for 90 days. The company focuses on developing innovative medications, notably its lead candidate FT218 for narcolepsy.
Avadel Pharmaceuticals announced promising results from the Phase 3 REST-ON clinical trial of its once-nightly treatment FT218 for narcolepsy, highlighting significant reductions in weekly cataplexy attacks and improved sleep latency when compared to placebo. Presented at the CHEST annual meeting, key findings revealed that a notable percentage of patients experienced a substantial decrease in cataplexy episodes. A discrete choice experiment indicated that once-nightly dosing is preferred by patients over twice-nightly dosing. FT218 is currently under FDA review, and if approved, may represent a vital treatment option.
Avadel Pharmaceuticals (AVDL) announced that the FDA's review of its New Drug Application for FT218 is ongoing, with no action expected in October. The FDA confirmed receipt of all necessary information, and no deficiencies have been reported. FT218 aims to treat excessive daytime sleepiness and cataplexy in narcolepsy patients, delivering positive results in its Phase 3 REST-ON study. The FDA previously granted FT218 Orphan Drug Designation, indicating the potential for clinical superiority over existing treatments. Avadel remains committed to patient access to FT218 as swiftly as possible.
Avadel Pharmaceuticals (Nasdaq: AVDL) supports World Narcolepsy Day on September 22, highlighting the importance of awareness for this chronic condition affecting approximately three million people globally. Their investigational drug candidate, FT218, designed to treat excessive daytime sleepiness and cataplexy in narcolepsy, is under FDA review with a target decision date of October 15, 2021. The company emphasizes its commitment to improving treatment and addressing the stigma faced by those with narcolepsy through educational initiatives and participation in relevant medical conferences.