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) announced that CEO Greg Divis will speak at several virtual investor conferences in September 2021. Key events include the Morgan Stanley 19th Annual Global Healthcare Conference on September 9, Wells Fargo Virtual Healthcare Conference on September 10, H.C. Wainwright’s 23rd Annual Global Investment Conference on September 13, and Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22. Live webcasts and recordings will be available for 90 days post-conference on the company's Investor Relations website.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced the publication of pivotal Phase 3 REST-ON trial data for FT218, an investigational sodium oxybate formulation, in the journal SLEEP. The study showed FT218's effectiveness in treating excessive daytime sleepiness and cataplexy in narcolepsy patients. With the FDA's Prescription Drug User Fee Act (PDUFA) target date set for October 15, 2021, the company expresses confidence in FT218's potential to transform narcolepsy treatment.
Avadel Pharmaceuticals reported significant progress in the second quarter of 2021, focusing on the potential FDA approval of FT218 for narcolepsy treatment. The New Drug Application for FT218 was accepted, with a PDUFA date set for October 15, 2021. Despite no revenue for Q2 2021 due to a previous product sale, R&D expenses rose to $6.8 million, driven by pre-launch activities. The net loss was $19.6 million, or $0.33 per diluted share. Cash reserves stood at $202.8 million, aiding the company's preparations for commercialization.
Avadel Pharmaceuticals (NASDAQ: AVDL) announced a conference call on August 9, 2021, at 8:30 a.m. ET to discuss its second-quarter financial results for 2021. The company is focusing on developing FT218, a once-nightly formulation of sodium oxybate aimed at treating excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy. Investors can participate through a dedicated phone line or via a live webcast on the company’s website.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced that its CEO, Greg Divis, will participate in a fireside chat on July 14 at 11:00 a.m. ET. The discussion will focus on FT218, an investigational treatment for excessive daytime sleepiness and cataplexy in adults with narcolepsy. A live webcast will be available on Avadel’s Investor Relations website, along with an archived recording accessible for 90 days after the event. This engagement highlights Avadel's commitment to advancing its innovative therapies.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced positive post hoc analyses from the Phase 3 REST-ON clinical trial of FT218, a once-nightly sodium oxybate formulation for narcolepsy. Data show significant improvements in excessive daytime sleepiness across narcolepsy subtypes, with substantial weight loss benefits for patients. FT218 demonstrated statistically significant efficacy at all doses evaluated, with a PDUFA date at the FDA set for October 15, 2021. The findings were presented at the SLEEP 2021 conference, highlighting FT218's potential as a transformative treatment for narcolepsy.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced it will present pivotal Phase 3 REST-ON clinical trial data for FT218 at the virtual SLEEP 2021 meeting from June 10-13, 2021. FT218, a once-nightly formulation of sodium oxybate, targets excessive daytime sleepiness and cataplexy in narcolepsy patients. The presentation includes six abstracts focusing on various efficacy and safety aspects. The FDA has accepted the NDA for FT218, aiming for a decision by October 15, 2021, and granted it Orphan Drug Designation, indicating potential clinical superiority over existing treatments.
Avadel Pharmaceuticals announces key leadership appointments to bolster its team ahead of the anticipated U.S. regulatory approval and commercialization of FT218, an investigational treatment for narcolepsy. Jeff Cruikshank joins as Vice President of Sales, Denise Strauss as Vice President of Marketing and New Product Strategy, and Angela Woods as Vice President of People and Culture. These roles are designed to enhance the company’s capabilities to support FT218’s market launch, which is expected to bring a significant impact to patients dealing with narcolepsy.
DUBLIN, Ireland, May 25, 2021 – Avadel Pharmaceuticals (Nasdaq: AVDL) announced that CEO Greg Divis will participate in a fireside chat on June 1 at 9:00 a.m. ET. This event will focus on FT218, an investigational once-nightly formulation of sodium oxybate aimed at treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. A live webcast and an archived recording will be accessible on Avadel’s Investor Relations website for 90 days following the conference.
Avadel Pharmaceuticals announced that the FDA accepted the NDA for once-nightly FT218, targeting a PDUFA date of October 15, 2021. Positive secondary endpoint data from the REST-ON trial was presented at the AAN 2021 Annual Meeting, indicating FT218's efficacy in improving sleep quality for narcolepsy patients. The company reported no revenue for Q1 2021, down from $12.2 million in Q1 2020, with a net loss of $13.4 million, or ($0.23) per share. However, cash reserves stand at $205 million, positioning the company well for upcoming developments.