공시 • Feb 14
Avadel Pharmaceuticals plc(NasdaqGM:AVDL) dropped from NASDAQ Composite Index Avadel Pharmaceuticals Limited has been dropped from the NASDAQ Composite Index. 공시 • Dec 18
Avadel Pharmaceuticals plc Announces Completion of Enrollment in Phase 3 REVITALYZ Trial in Idiopathic Hypersomnia Avadel Pharmaceuticals plc announced the completion of patient enrollment in REVITALYZ, a Phase 3 trial evaluating LUMRYZTM (sodium oxybate) extended-release oral suspension as a potential treatment for idiopathic hypersomnia (IH). The trial is evaluating study participants switching from immediate-release oxybates as well as those not currently taking oxybates. LUMRYZ is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. The FDA approval of LUMRYZ was supported by results from REST-ON™?, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcoleps. With its approvals in May 2023 and October 2024, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcole epilepsy and in pediatric patients seven years of age and older with narcolepsy respectively due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular, the FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose. In June 2025, the FDA granted Orphan Drug Designation to LUMRYZ for The treatment of IH based on the plausible hypothesis that LUMRYZ may be clinically superior to the same drug(s) already approved for the same indication, because LUMRYZ may provide a major contribution to patient care due to its once-nightly dosing for patients with IH, a chronic sleep disorder that requires potentially lifelong treatment. LUMRYZ is only currently approved for the treatment of catap Flexy or EDS in patients seven years of age and old with narcolepsy, and Avadel does not market, promote or offer patient support services for use of LUMRYZ in any indication beyond narcolepsy. 공시 • Nov 14
H. Lundbeck A/S (CPSE:HLUN B) submitted a non binding proposal to acquire Avadel Pharmaceuticals plc (NasdaqGM:AVDL) for $ 2.1 billion. H. Lundbeck A/S (CPSE:HLUN B) submitted a non binding proposal to acquire Avadel Pharmaceuticals plc (NasdaqGM:AVDL) for $ 2.1 billion on November 14, 2025. The transaction is valued at $21 per share in cash with a CVR for an Additional $2 per Share in Cash, for Total Consideration of up to $23 per share. CVR for an Additional $2 per Share in Cash comprises of $1.00 per ordinary share, contingent upon LUMRYZ and valiloxybate collectively reaching total annual net sales for end-use in the United States of at least $450 million in any calendar year by December 31, 2027 and $1 per ordinary share, contingent upon LUMRYZ and valiloxybate collectively reaching total annual net sales for end-use in the United States of at least $700 million in any calendar year by December 31, 2030. The deal is subject to approval of shareholders and board of Avadel Pharmaceuticals plc and regulatory approval. In a related transaction, Avadel entered into a definitive transaction agreement with Alkermes under which Alkermes will acquire all outstanding ordinary shares of Avadel for total purchase price of up to $20 per share.
Under the transaction agreement with Alkermes, the Avadel Board’s determination that the unsolicited Lundbeck Proposal would reasonably be expected to result in a Company Superior Proposal at this time allows Avadel to provide information to and conduct discussions and negotiations with Lundbeck, but does not allow Avadel to terminate its agreement with Alkermes or enter into any other agreement with Lundbeck. Avadel’s Board has not determined that the Lundbeck Proposal in fact constitutes a Company Superior Proposal under the existing transaction agreement with Alkermes and has not changed its recommendation in support of the Alkermes acquisition at this time.
Goldman Sachs & Co. LLC and Morgan Stanley & Co. LLC acted as financial advisors to Avadel Pharmaceuticals plc. Goodwin Procter LLP and Arthur Cox LLP acted as legal advisor to Avadel Pharmaceuticals plc. PJT Partners Inc. acted as financial advisor to H. Lundbeck A/S. 공시 • Sep 05
Avadel Pharmaceuticals plc to Present New Data on LUMRYZ (sodium Oxybate) for Extended-Release Oral Suspension at World Sleep 2025 Avadel Pharmaceuticals plc announced that new data supporting the use of LUMRYZ as a narcolepsy treatment will be presented in one oral presentation and 16 posters at World Sleep 2025, taking place September 5-10, in Singapore. Additional highlights from the presentations at World Sleep 2025 include: Updated and new results from an interim descriptive analysis of data from REFRESH (n=51), a prospective multicenter, real-world study in patients with narcolepsy, including those who switched to LUMRYZ from twice-nightly and those new to oxybate or returning to oxybate after discontinuing twice-nightly oxybate. Results showed that participants experienced clinically meaningful improvements in Epworth Sleepiness Scale (ESS) scores, a measure of excessive daytime sleepiness (EDS), to within the normal range. REFRESH study participants experienced a reduction in severity from moderate at the start of the study to mild at study end for the pentad of narcolepsy symptoms measured on the Narcolepsy Severity Scale (NSS) and reduced interference across domains on the Sheehan Disability Scale (SDS). After completing 4 months of therapy (switch participants, n=20; non-switch, n=31), 70% and 76% of switch participants and 90% and 87% of non-switch participants were improved on the Patient Global Impression of Change and the Clinician Global Impression of Change, respectively. Additional interim results from a study questionnaire and end of study survey showed that overall quality of life, fatigue, brain fog, depression, anxiety, and mood improved and as-needed use of stimulants was reduced. To characterize the comorbidities of patients with narcolepsy., an analysis of aggregate patient data from electronic health records (EHR) was conducted at Duke University. Results from 1,659 patients with narcolepsy and 1,659 matched controls showed sleep, pain and psychiatric or mood disorders occurred significantly more frequently in patients with Narcolepsy versus the control group (all p<0.1). LUMRYZ is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or EDS in adults with narcolepsy. On October 16, 2024, LUMRYZ was additionally approved as a once-at-time treatment for cataplexY or EDS in pediatric patients seven years of age and older with narcolepsy. The FDA approval of LUMRYZ was supported by results from REST-ON™?, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcoleps. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS (MWT), clinicians' overall assessment of patients' functioning (CGI-I), and cataplexy attacks, for all three evaluated doses when compared to placebo. With its dose, the single bedtime dose, demonstrated in the REFRESH study to result in clinically meaningful outcomes for both switch and naive oxybate patients. 
