View Future GrowthThis company listing is no longer activeThis company may still be operating, however this listing is no longer active. Find out why through their latest events.See Latest EventsAvadel Pharmaceuticals 過去の業績過去 基準チェック /06Avadel Pharmaceuticalsの収益は年間平均-5.9%の割合で減少していますが、 Pharmaceuticals業界の収益は年間 増加しています。収益は年間8.8% 73.3%割合で 増加しています。主要情報-5.94%収益成長率0.014%EPS成長率Pharmaceuticals 業界の成長7.33%収益成長率73.27%株主資本利益率-0.28%ネット・マージン-0.11%前回の決算情報30 Sep 2025最近の業績更新お知らせ • Jul 31Avadel Pharmaceuticals plc to Report Q2, 2025 Results on Aug 07, 2025Avadel Pharmaceuticals plc announced that they will report Q2, 2025 results on Aug 07, 2025お知らせ • Apr 30Avadel Pharmaceuticals plc to Report Q1, 2025 Results on May 07, 2025Avadel Pharmaceuticals plc announced that they will report Q1, 2025 results on May 07, 2025お知らせ • Feb 25Avadel Pharmaceuticals plc to Report Q4, 2024 Results on Mar 03, 2025Avadel Pharmaceuticals plc announced that they will report Q4, 2024 results on Mar 03, 2025Reported Earnings • Nov 13Third quarter 2024 earnings released: US$0.027 loss per share (vs US$0.41 loss in 3Q 2023)Third quarter 2024 results: US$0.027 loss per share (improved from US$0.41 loss in 3Q 2023). Revenue: US$50.0m (up US$43.0m from 3Q 2023). Net loss: US$2.63m (loss narrowed 93% from 3Q 2023). Revenue is forecast to grow 29% p.a. on average during the next 3 years, compared to a 3.5% growth forecast for the Pharmaceuticals industry in Germany.お知らせ • Nov 04Avadel Pharmaceuticals plc to Report Q3, 2024 Results on Nov 12, 2024Avadel Pharmaceuticals plc announced that they will report Q3, 2024 results on Nov 12, 2024お知らせ • Aug 02Avadel Pharmaceuticals plc to Report Q2, 2024 Results on Aug 08, 2024Avadel Pharmaceuticals plc announced that they will report Q2, 2024 results on Aug 08, 2024すべての更新を表示Recent updatesお知らせ • Feb 14Avadel Pharmaceuticals plc(NasdaqGM:AVDL) dropped from NASDAQ Composite IndexAvadel Pharmaceuticals Limited has been dropped from the NASDAQ Composite Index.お知らせ • Feb 12+ 21 more updatesAvadel Pharmaceuticals plc Announces Board of Director ChangesAvadel Pharmaceuticals plc announced that Additionally, as of the Effective Time, each of Geoffrey M. Glass, Gregory J. Divis, Dr. Eric J. Ende, Dr. Mark A. McCamish, Linda S. Palczuk, Peter J. Thornton and Dr. Naseem S. Amin ceased serving as a member of the board of directors of Avadel and each committee thereof on which such director served.お知らせ • Dec 18Avadel Pharmaceuticals plc Announces Completion of Enrollment in Phase 3 REVITALYZ Trial in Idiopathic HypersomniaAvadel 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.お知らせ • Nov 14H. 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.お知らせ • Oct 22+ 1 more updateAlkermes plc (NasdaqGS:ALKS) entered into a definitive agreement to acquire Avadel Pharmaceuticals plc (NasdaqGM:AVDL) for $1.8 billion.Alkermes plc (NasdaqGS:ALKS) entered into a definitive agreement to acquire Avadel Pharmaceuticals plc (NasdaqGM:AVDL) for $1.8 billion on October 22, 2025. Transaction Valued at $18.50 per Share in Cash with a CVR for an Additional $1.50 per Share in Cash, for Total Consideration of up to $20.00 per share Subject and pursuant to the terms of the CVR Agreement, each CVR will represent the contractual right to receive the Milestone Payment upon the occurrence of each of: approval by the United States Food and Drug Administration (the "FDA") of an application submitted to the FDA for the commercial marketing and sale of the CVR Product in the United States for the Indication; provided, that, such approval shall be deemed achieved upon receipt of written notice from the FDA that the CVR Product has been approved for the Indication in the United States and which is not blocked by any third party orphan-drug exclusivity, regardless of whether any risk evaluation and mitigation strategies or other conditions are imposed by the FDA ("LUMRYZ Approval"); and the dismissal of the Claims with prejudice by the United States District Court for the District of Delaware pursuant to the Settlement and License Agreement, by and between Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited, on the one hand, and Avadel CNS Pharmaceuticals LLC and Flamel Ireland Limited, on the other hand, dated October 21, 2025 between the Company and Jazz Pharmaceuticals, Inc. (such occurrence, the "Legal Event," and together with LUMRYZ Approval, the "Milestone"). If the Milestone is not achieved by the Milestone Expiration, then the CVRs will have no value. The minimum payment under each CVR is zero; if the Milestone Payment is made, the payment under each CVR is $1.50. It is intended that, subject to and following the Scheme becoming effective, and subject to applicable laws and rules and policies of Nasdaq, the Company Shares will be delisted from the Nasdaq Global Market and deregistered, along with any other Company securities registered under the Exchange Act, if any, as promptly as practicable after the Effective Time. As a result of the Scheme, Avadel will become a wholly owned subsidiary of Alkermes. Alkermes reserves the right, subject to the terms of the Transaction Agreement, to elect to implement the Acquisition by way of a takeover offer (as such term is defined in the Irish Takeover Rules) rather than the Scheme. The Bridge Credit Agreement provides for a senior secured bridge term loan facility (the “Bridge Credit Facility”) in an aggregate principal amount of up to $1,231,459,813.22 that is available to finance the payment of Cash Consideration and fees and expenses related to the Acquisition. Following Completion, the global headquarters of the Combined Group will be located at Alkermes' current global headquarters in Dublin, Ireland. Alkermes will, as part of its review of the Company's business referred to above, evaluate the consolidation of some or all of the Company's locations of business, including functions currently undertaken at the Company's U.S. headquarters in St. Louis, Missouri, into Alkermes' global headquarters in Dublin, Ireland and other locations of Alkermes across the United States. The Acquisition is subject to the satisfaction or waiver (as applicable) of the Conditions, which are set out in full in Appendix III (Conditions of the Acquisition and the Scheme) to this Announcement, including, in summary the approval by the Company Shareholders of the Scheme; the sanction by the High Court of the Scheme; the receipt of required antitrust Clearances in the United States; the Transaction Agreement not having been terminated in accordance with its terms; the absence of a Company Material Adverse Effect that is continuing; the absence of a Parent Material Adverse Effect that is continuing; the accuracy of each of the Parties' representations and warranties, except generally as would not have a material adverse effect on such Party; and the performance by each Party, in all material respects, with all of its covenants and agreements under the Transaction Agreement. The transaction is expected to close in the first quarter of 2026. The board of directors of Avadel Pharmaceuticals has unanimously determined that the Acquisition by Alkermes is in the best interests of all Shareholders and has unanimously approved the Acquisition. The Acquisition has also been approved by the board of directors of Alkermes. The transaction is expected to be immediately accretive upon closing and represents a compelling financial and strategic opportunity, leveraging Alkermes' existing commercial expertise and operational infrastructure and adding new capabilities in rare disease. The transaction is expected to be immediately accretive upon closing and represents a compelling financial and strategic opportunity, leveraging Alkermes' existing commercial expertise and operational infrastructure and adding new capabilities in rare disease. Jeremy Meilman, Andy Ham Dwayne Lysaght and Edward Hatter of J.P. Morgan Securities LLC and J.P. Morgan Securities plc acted as financial advisors, James E.Langston; and Chelsea N. Darnell of Paul, Weiss, Rifkind, Wharton & Garrison LLP and Stephen FitzSimons and Jack Kelly of McCann FitzGerald LLP acted as legal advisors for Alkermes plc. Cleary Gottlieb Steen & Hamilton LLP is acting as legal counsel to Alkermes for the financing. Peter van der Goes, Ryan Fisk and Emily West Warren Stables of Goldman Sachs & Co. LLC, Tedd Smith, Daniel Cohen, David Kitterick and Ben Nassau of Morgan Stanley & Co. International plc and Morgan Stanley & Co. LLC acted as financial advisors, while Robert Puopolo, Blake Liggio, Caitlin Tompkins, and Stephanie Isaia of Goodwin Procter LLP and Christopher McLaughlin; and David Vos of Arthur Cox LLP acted as legal advisors for Avadel Pharmaceuticals plc. Goldman Sachs & Co. LLC and Morgan Stanley & Co. LLC acted as fairness opinion providers for Avadel Pharmaceuticals plc.お知らせ • Sep 05Avadel Pharmaceuticals plc to Present New Data on LUMRYZ (sodium Oxybate) for Extended-Release Oral Suspension at World Sleep 2025Avadel 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.お知らせ • Aug 07+ 1 more updateAvadel Pharmaceuticals plc Raises Revenue Guidance for the Full Year of 2025Avadel Pharmaceuticals plc raised revenue guidance for the full year of 2025. For the year, the company expects revenue to be between $265 million to $275 million.お知らせ • Jul 31Avadel Pharmaceuticals plc to Report Q2, 2025 Results on Aug 07, 2025Avadel Pharmaceuticals plc announced that they will report Q2, 2025 results on Aug 07, 2025お知らせ • Jul 14ASL Strategic Value Fund Files an Exempt Solicitation Statement with Securities and Exchange CommissionOn July 14, 2025, ASL Strategic Value Fund LP announced that it has filed an exempt solicitation statement with Securities and Exchange Commission, recommended the shareholders of Avadel Pharmaceuticals plc to vote against the Company board nominees and call on the Company to appoint an independent election monitor to oversee the Annual Meeting vote, subject to shareholder approval, at the annual meeting of shareholders scheduled to be held on July 29, 2025.お知らせ • Jul 02ASL Strategic Value Fund Issues Open Letter to Avadel ShareholdersOn June 30, 2025, ASL Strategic Value Fund, LP announced that it has issued an open letter calling on Avadel Pharmaceuticals plc’s shareholders to vote against all of the Company’s director nominees up for election at the 2025 annual general meeting of shareholders scheduled for July 29, 2025.ASL Strategic Value stated that it has sent its previous letter previous letter to the Company’s board of directors dated February 10, 2025, where it has called on the Board to embark on a new course of action designed to maximize the Company’s value for all long-suffering shareholders to which the Board has failed to appropriately respond. ASL Strategic Value added that it has called on the Board to retain an investment bank to monetize the significant value inherent in the Company’s best-in-class asset LUMRYZ which has been found by the U.S. Food and Drug Administration on two separate occasions to be "clinically superior" to any other sodium oxybate, just last week the FDA granted orphan drug designation for LUMRYZ for a new indication idiopathic hypersonia. The regulatory pathway for an IH approval is now quite clear, and if approved by the FDA, this additional indication could add an additional $500 million to $1 billion to the Company’s annual revenues.ASL Strategic Value stated that in its letter to the Board, dated May 14, 2025, it had negative experience in a prior the Company director election with ASL Strategic Value Fund's votes being improperly counted. In that election it approximately 1.28 million shares, which were voted against each director were not counted or disclosed in the final vote count. It was only after ASL Strategic counsel had contacted the Company about this serious omission that a corrective 8-K was later quietly filed with a corrected vote count, so to ensure that the vote at the upcoming election is fair and honest, it has called for an impartial election monitor to be appointed (with the approval of the shareholders).お知らせ • Jun 30Avadel Pharmaceuticals Announces Unanimous Appeals Court Decision Upholding FDA Approval of LUMRYZ in Narcolepsy in Administrative Procedure Act LitigationAvadel Pharmaceuticals plc announced that, on June 27, 2025, the U.S. Court of Appeals for the District of Columbia Circuit (the Appeals Court) affirmed a prior decision of the U.S. District Court for the District of Columbia (the District Court) in favor of the U.S. Food and Drug Administration (FDA) in a suit brought by Jazz Pharmaceuticals Inc. (Jazz) regarding the FDA’s approval of LUMRYZTM, the first and only once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. Following the District Court’s ruling in favor of the FDA and Avadel in October 2024, which granted the FDA’s Motions for Summary Judgment with respect to Jazz’s complaint and denied Jazz’s Motion for Summary Judgment, Jazz filed a notice of appeal to the Appeals Court. On June 27, 2025, the Appeals Court, in a unanimous panel decision, affirmed the District Court’s ruling and upheld the FDA’s approval of LUMRYZ.お知らせ • Jun 19Avadel Pharmaceuticals plc, Annual General Meeting, Jul 29, 2025Avadel Pharmaceuticals plc, Annual General Meeting, Jul 29, 2025. Location: arthur cox llp, ten earlsfort terrace, dublin 2, d02 t380, Irelandお知らせ • May 30Avadel Pharmaceuticals plc to Present New Data on LUMRYZ™? (sodium Oxybate) for Extended-Release Oral Suspension at Sleep 2025Avadel Pharmaceuticals plc announced that new data supporting the use of LUMRYZ as a narcolepsy treatment and additional data to better understand the real-life experience of people living with narcolepsy will be presented in four oral presentations and 14 posters at SLEEP 2025, the 39th Annual Meeting of the Associated Professional Sleep Societies (APSS), taking place June 8-11, 2025 in Seattle. Post-hoc analysis of the pivotal Phase 3 REST-ON clinical trial, restricted to those study participants with the most severe sleepiness at baseline as measured both objectively and subjectively, showed LUMRYZ participants with a median Epworth Sleepiness Scale (ESS) score at Week 13 that was improved to the range at or below that considered normal. Highlights from the presentations at SLEEP 2025 include: Interim REFRESH results demonstrating that among 67 patients (approximately half oxybate naïve, 37% switches from twice-nightly oxybates, and the remainder previous twice-nightly oxybate users); patients in all groups achieved clinically significant reductions in sleepiness, with normal ESS scores after starting LUMRYZ. A post-hoc analysis restricted to the most severely sleepy tertiles at baseline in REST-ON; at the end of the study, median ESS was at or below the normal threshold with LUMRYZ. A post-hoc analysis from REST-ON to quantify hypnagogic and hypnopompic hallucinations (HH) during the trial; these aggregate data show that LUMRYZ participants reported approximately half as many HH events where they felt like they were going to be attacked, flying through the air, or falling into a hole compared to placebo. A post-hoc analysis from REST-ON demonstrating consistency of LUMRYZ efficacy across objective and subjective disrupted nighttime sleep outcomes in various subgroups (e.g., narcolepsy type 1 or 2, male or female, stimulant use). A retrospective chart analysis of patients with sleep-related eating disorder (SRED) while on twice-nightly oxybates, which was ameliorated after switching to LUMRYZ. A post hoc analysis from the stable dosing period of the RESTORE open-label study evaluating 115 participants (median treatment: 503 days) who switched from twice-nightly oxybate to LUMRYZ; side effects were consistent with the known adverse events of oxybates and only 4% of participants discontinued LUMRYZ due to a treatment-related adverse event, underscoring the long-term tolerability of LUMRYZ. A survey conducted in collaboration with MyNarcolepsyTeam of 88 respondents, revealing the need for enhanced patient-clinician discussions of oxybates as a treatment option, as well as better setting of oxybate treatment expectations to minimize discontinuations, particularly as they relate to side effects that are generally transient in nature.お知らせ • May 07Avadel Pharmaceuticals plc Raises Earnings Guidance for the Full Year 2025Avadel Pharmaceuticals plc announced that it Raises 2025 full year guidance to $255 - $265 million in net product revenue.お知らせ • May 06Avadel Pharmaceuticals Announces Favorable Ruling in Appeal of Delaware Court InjunctionAvadel Pharmaceuticals plc announced that the United States Court of Appeals for the Federal Circuit (the “Federal Circuit”) has ruled in favor of Avadel, overturning important parts of the injunction imposed by the U.S. District Court for the District of Delaware (the “Delaware Court”) regarding LUMRYZ™ as a potential treatment of indications beyond narcolepsy. The Federal Circuit vacated the portion of the injunction that prohibited Avadel from applying for FDA approval of LUMRYZ for any indication beyond narcolepsy, calling the district court’s analysis “simply too speculative and tenuous.” Additionally, the Federal Circuit lifted the portions of the Delaware Court's injunction that prohibited Avadel from offering open-label extensions to trial participants using LUMRYZ and from initiating new clinical trials or studies with LUMRYZ for potential indications beyond narcolepsy. Patient enrollment in Avadel’s REVITALYZ™ trial remains on track to be completed by the end of 2025. REVITALYZ is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 study designed to evaluate the efficacy and safety of LUMRYZ given as a once-at-bedtime dose, in IH. The study will enroll approximately 150 adults who are diagnosed with IH and is open for participants switching from immediate-release oxybates and to those not currently taking oxybates.お知らせ • Apr 30Avadel Pharmaceuticals plc to Report Q1, 2025 Results on May 07, 2025Avadel Pharmaceuticals plc announced that they will report Q1, 2025 results on May 07, 2025お知らせ • Apr 17Avadel and nference Announce Publication of Real-World Data on Sodium Oxybate Treatment Patterns in the Journal of Clinical NeuroscienceAvadel Pharmaceuticals plc and nference announced the publication of real-world data on comorbidities and treatment patterns of people with narcolepsy treated versus not treated with immediate-release sodium oxybate. The paper, titled " Characterization and Treatment patterns of Patients Treated With Immediate-Release Sodium oxybate for Narcolepsy: A Propensity-Matched Cohort Study," was published online in the Journal of Clinical Neuroscience. A review of de-identified electronic health records (EHR) from patients at Mayo Clinic identified 4,387 individuals living with narcolepsy, of whom 351 had received immediate-release sodium oxybates treatment. This cohort of 351 patients with narcolepsy treated with sodium oxybate was age/sex matched with a cohort of 351 patients with narColepsy without sodium oxybate treatment. The retrospective analysis was conducted through Mayo Clinic's Clinical Data Analytics Platform, which leverages nference's AI software to provide access to curated, deidentified electronic health data in a secure, privacy-protected environment. These types of data provide a more comprehensive view of patient information than claims data alone. Other relevant findings included high rates of insomnia in both groups (approximately 43%), reflecting the frequent disruptive nighttime sleep inherent in narcolepsy," said Melissa Lipford, M.D., a neurologist at the Center for Sleep Medicine at Mayo Clinic and lead author of the published paper. The high rate of idiopathic hypersomnia (IH) diagnosis underscores the challenges with identifying between narcolepsy and IH based upon current testing. These findings also revealed insights into challenges with middle-of-the-night sodium oxybate dosing and lessened efficacy when the second dose wasomitted.お知らせ • Mar 25Avadel Pharmaceuticals plc Announces Publications in CNS Drugs Supplement Highlighting Key Clinical Issues for People with Narcolepsy and Their CliniciansAvadel Pharmaceuticals plc announced the publication of six manuscripts covering clinical management, shared decision-making and goal setting for people with narcolepsy and their clinicians in a CNS Drugs supplement titled "A New Dawn in the Management of Narcolepsy". Summary of Papers in CNS Drugs Supplement: Narcolepsy: Beyond the Classic Pentad Authored by Anne Marie Morse, D.O., Director of Pediatric Neurology at Geisinger Medical Center and others, this paper addresses the full 24-hour impact and symptom burden that patients experience, as well as the need for an individualized treatment approach and care considerations that extend beyond the hallmark features of the disease. A Survey of People Living With Narcolepsy in the USA: Path to Diagnosis, Authored by Luis E. Ortiz, M.D., Assistant Professor of Pediatrics at Johns Quality of Life, and Treatment Landscape From the Patient's Perspective Hopkins Medicine and others, the survey reports data from 110 people living with narcolepsy. Among the key findings: nearly three-fourths (72%) of responders experienced some form of nighttime sleep disturbance (such as disrupted nighttime sleep and fragmented sleep) and approximately one-third (33%) of sodium oxybate users reported their top treatment goal was medicine to help them sleep through the night. Sodium Oxybate: Practical Considerations and Patient Perspectives Authored by Maggie Lavender, M.S.N., of Comprehensive Sleep Medicine Associates in Houston, Texas and others, this paper includes illustrative clinical case scenarios of two people with narcolepsy, providing clinicians with a proposed framework to optimize discussions with patients and certify sodium oxybate treatment, providing practical tips and support for initiating and maintaining therapy.お知らせ • Mar 03Avadel Pharmaceuticals Reiterates Earnings Guidance for the Year 2025Avadel Pharmaceuticals reiterated earnings Guidance for the year 2025. For the period, the company expects to generate $240 million to $260 million in net product revenue as the number of patients on LUMRYZ is expected to grow to 3,300 to 3,500.お知らせ • Feb 25Avadel Pharmaceuticals plc to Report Q4, 2024 Results on Mar 03, 2025Avadel Pharmaceuticals plc announced that they will report Q4, 2024 results on Mar 03, 2025お知らせ • Jan 09+ 1 more updateAvadel Pharmaceuticals plc Provides Update on Revitalyz Pivotal StudyAvadel Pharmaceuticals plc provided update on REVITALYZ pivotal study. the company announced that patient enrollment is ongoing in the REVITALYZ pivotal study, a Phase 3 double-blind, placebo-controlled, randomized withdrawal, multicenter study designed to evaluate the efficacy and safety of LUMRYZ in IH. Completion of this study is expected during the second half of 2025. Preclinical development ongoing for a once-nightly, low-/no-sodium oxybate formulation with a target product profile bioequivalent to LUMRYZ.お知らせ • Dec 04Avadel Pharmaceuticals plc Announces Step Down of Richard Kim as Chief Commercial Officer Effective as of December 31, 2024On December 2, 2024, Richard Kim notified Avadel Pharmaceuticals plc (the Company) that he will step down as Chief Commercial Officer effective as of December 31, 2024.Reported Earnings • Nov 13Third quarter 2024 earnings released: US$0.027 loss per share (vs US$0.41 loss in 3Q 2023)Third quarter 2024 results: US$0.027 loss per share (improved from US$0.41 loss in 3Q 2023). Revenue: US$50.0m (up US$43.0m from 3Q 2023). Net loss: US$2.63m (loss narrowed 93% from 3Q 2023). Revenue is forecast to grow 29% p.a. on average during the next 3 years, compared to a 3.5% growth forecast for the Pharmaceuticals industry in Germany.お知らせ • Nov 04Avadel Pharmaceuticals plc to Report Q3, 2024 Results on Nov 12, 2024Avadel Pharmaceuticals plc announced that they will report Q3, 2024 results on Nov 12, 2024お知らせ • Oct 26Avadel Pharmaceuticals and nference, Inc. Publish Real-World Data on Narcolepsy in Sleep AdvancesAvadel Pharmaceuticals plc and nference announced the publication of real-world data that identified the demographic characteristics and the top 20 most prevalent comorbidities of people living with narcolepsy. The paper, titled “Demographic Characteristics and Comorbidities of Patients With Narcolepsy: A Propensity-Matched Cohort Study,” was published online in Sleep Advances. These real-world findings were previously presented at the American Neurological Association (ANA) Annual Meeting in October 2022. Results describing demographic characteristics and the top 20 comorbidities were based on a review of deidentified electronic health data from more than 2,000 people with narcolepsy and 2,000 matched controls. The retrospective analysis was conducted through Mayo Clinic Platform, which leverages nference’s AI software to provide access to curated, deidentified electronic health data in a secure, privacy-protected environment. These types of data provide a more comprehensive view of patient information than claims data alone.お知らせ • Oct 17Avadel Pharmaceuticals Announces FDA Approval of LUMRYZ (sodium oxybate) Extended-Release Oral Suspension (CIII) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Patients 7 Years of Age and Older with NarcolepsyAvadel Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for LUMRYZ for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. This approval represents an important milestone for the narcolepsy community, specifically for younger narcolepsy patients and their caregivers who face significant challenges associated with waking up in the middle of the night to complete treatment regimens. Symptoms of narcolepsy are EDS and may also include a sudden loss of muscle tone usually triggered by strong emotion (cataplexy), disrupted nighttime sleep, sleep paralysis and hallucinations when falling asleep or waking up. LUMRYZ is a once-at-bedtime formulation extended-release sodium oxybate and was first approved by the FDA on May 1, 2023, for the treatment of catap Flexy or EDS in adult patients with narcolepsy. LUMRYZ was approved by the FDA for use in the treatment of cataplexY or EDS in the pediatric narcolepsy population 7 years and older on October 16, 2024, and was granted Orphan Drug Exclusivity through October 16, 2031. LUMRYZ has a boxed warning as a central nervous system depressant, and for its potential for abuse and misuse. LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the LUMRYZ REMS. Most common adverse reactions (incidence > 5% and greater than placebo) reported for all doses of LUMRYZ combined in a trial of adults with narcolepsy were nausea, dizziness, enuresis, headache, and vomiting. LUMRYZ is an extended-release sodium oxybates medication approved by the FDA on May1, 2023, as the first and only once-at-bedtime treatment for cataplexy or E DS 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 approval in May 2023, the FDA also granted 7 years of Orphan Drug Exclusivity to LUMRYZ for thetreatment of cataplexy orEDS in adults with narcole epilepsy 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. Avadel's commercial product, LUMRYZ, was approved by the FDA's commercial product, LUMryZ, was approved by the company's commercial product, LUMYZ, was approved by the Company's commercial product, LumRYZ, was approved by The Company's commercial product, LUMRIZ, was approved by the company's commercial product.お知らせ • Sep 04Avadel Pharmaceuticals plc Announces Publication of Restore Data Highlighting Challenges with Twice-Nightly Oxybates and Strong Patient Preference for Once-Nightly LUMRYZ Dosing (sodium Oxybate) Extended-Release Oral Suspension (CIII)Avadel Pharmaceuticals plc announced the publication of final data from the RESTORE open-label/switch study, demonstrating that people with narcolepsy prefer once-at-bedtime LUMRYZ versus a twice-nightly immediate-release oxybate treatment option. The U.S. Food and Drug Administration approved LUMRYZ in 2023 as the first and only once-nightly oxybate, which marked a significant milestone for people with narcolepsy, as twice-nightly oxybates were the only other oxybate options available for more than 20 years. Initial and end-of-study survey data from RESTORE were previously presented in April 2022 at the American Academy of Neurology Annual Meeting and in June 2024 at SLEEP 2024. Of the 129 switch participants who completed the nocturnal adverse events questionnaire at baseline: 69% reported missing their second oxybate dose, and of those participants, 80% felt that control of their symptoms was worse the next day compared to days after which they had taken both doses as prescribed. More than half (51%) of the 51 participants who took their second nightly oxybate dose more than four hours after the first dose reported feeling somewhat to extremely groggy or unsteady the next morning. 92% reported getting out of bed after taking their second dose of oxybate, with 7.5% of those reporting falling after waking up for the second dose, and 4.2% reporting injuries. 23% of participants stated they required another person to wake with them in the middle of the night to ensure they took the second dose of their twice-nightly oxybate dosing. Of the 68 switch participants who completed the end-of-study questionnaire: 79% were very satisfied with LUMRYZ compared to other narcolepsy treatments they had previously taken. 93% would recommend LUMRYZ to a family member or friend with narcolepsy. 91% said they were better able to sleep through the night since starting treatment with LUMRYZ. 91% said they were best able to follow the recommended medication schedule of LUMRYZ than their previous oxybate.New Risk • Sep 01New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$114m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. This is currently the only risk that has been identified for the company.お知らせ • Aug 20Avadel Pharmaceuticals plc Announces Publication in Clinical Therapeutics of Data Highlighting Weight Loss in People with Narcolepsy Treated with LUMRYZ™ (sodium oxybate) Extended-Release Oral SuspensionAvadel Pharmaceuticals plc announced the publication of results of a post-hoc analysis from the completed pivotal Phase 3 REST-ON clinical trial demonstrating greater weight loss in patients who received LUMRYZ compared with placebo. The paper, titled " weight Loss With Once-nightly Sodium oxybate for the Treatment of Narcolepsy: Analysis From the Phase III Randomized study Evaluating the efficacy and SafeTy of a ONce nightly formulation of sodium oxybate (REST-ON) Trial," was published online in Clinical Therapeutics. A significant reduction in BMI was observed after 13 weeks of treatment with LUMRYZ versus placebo, with a between-group difference in least squares mean change from baseline of 0.59 kg/m2 (p=0.001). In the weight loss group, participants shifted from obese into overweight, and from overweight into normal weight during this trial; no participants were underweight. 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. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS, clinicians' overall assessment of patients' functioning (CGI-I), and cataplexy attacks, for all three evaluated doses when compared to placebo. With its approval, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcole epilepsy 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.New Risk • Aug 09New minor risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow. Free cash flow: -US$114m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. This is currently the only risk that has been identified for the company.お知らせ • Aug 02Avadel Pharmaceuticals plc to Report Q2, 2024 Results on Aug 08, 2024Avadel Pharmaceuticals plc announced that they will report Q2, 2024 results on Aug 08, 2024お知らせ • Aug 01Avadel Pharmaceuticals plc Announces First Patient Dosed in Phase 3 REVITALYZ Trial of LUMRYZ (sodium oxybate) Extended-Release Oral Suspension for the Treatment of Idiopathic HypersomniaAvadel Pharmaceuticals plc announced that the first patient has been dosed in REVITALYZ, a Phase 3 study evaluating LUMRYZ as a potential treatment for idiopathic hypersomnia (IH). REVITALYZ is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 study designed to evaluate the efficacy and safety of LUMRYZ given as a once-at-bedtime dose, in IH. The study will enroll approximately 150 adults who are diagnosed with IH and includes an open label extension portion. REVITALYZ enrollment is open for both participants switching from immediate-release oxybates and not currently taking oxybates. The primary objective of REVITALYZ is to demonstrate reduction in daytime sleepiness as measured by the primary endpoint, change in total score of the Epworth Sleepiness Scale (ESS) at Week 14. Secondary endpoints will evaluate the effect of LUMRYZ on additional efficacy parameters including patient and clinician impression of change, idiopathic hypersomnia severity, and a measure of the functional outcomes of sleep. 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 narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS, clinicians’ overall assessment of patients’ functioning (CGI-I), and cataplexy attacks, for all three evaluated doses when compared to placebo.?With its approval, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy 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.お知らせ • Jun 20Avadel Pharmaceuticals plc, Annual General Meeting, Jul 30, 2024Avadel Pharmaceuticals plc, Annual General Meeting, Jul 30, 2024. Location: arthur cox llp, ten earlsfort terrace, d02 t380, dublin 2, Irelandお知らせ • May 24Avadel Pharmaceuticals plc Appoints Naseem Amin to Its Board of DirectorsAvadel Pharmaceuticals plc announced the appointment of Naseem Amin, M.D. to its board of directors, effective May 17, 2024. Dr. Amin, a highly successful executive who brings global industry and leadership experience to Avadel, currently serves as Chief Executive Officer of Orphalan SA. Dr. Amin brings to Avadel thirty years of international industry executive leadership and expertise in business development, venture capital, and research and development. He is currently Chief Executive Officer of Orphalan SA, a role he has held since June 2017. Dr. Amin previously served as Executive Chairman at Arix Bioscience plc, until April 2021, and was Venture Partner at Advent Life Sciences until 2020. Earlier, he was the Chief Scientific Officer at Smith and Nephew until 2014, overseeing corporate R&D, divisional manufacturing, and product development functions. Previous to that, Dr. Amin was Senior Vice President, Business Development, at Biogen Idec from 2005 to 2009, was with Genzyme Corporation from 1999 to 2005, and began his career at Baxter Healthcare Corporation. Dr. Amin received his medical degree from the Royal Free School of Medicine, London, and his MBA from the Kellogg Graduate School of Management, Northwestern University.お知らせ • May 23Avadel Pharmaceuticals Shares New LUMRYZ (sodium Oxybate) for Extended-Release Oral Suspension (CIII) Data at Sleep 2024Avadel Pharmaceuticals plc announced it will present 11 posters, and one oral presentation, supporting the use of LUMRYZ as a narcolepsy treatment option at SLEEP 2024, the 38th annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society on June 1-5, 2024, in Houston. Approved by the U.S. Food and Drug Administration (FDA) in 2023, LUMRYZ is the first and only extended-release formulation of sodium oxybate and indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. LUMRYZ has a boxed warning as a central nervous system depressant, and for its potential for abuse and misuse. LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the LUMRYZ REMS. Most common adverse reactions (incidence >5% and greater than placebo) reported for all doses of LUMRYZ combined were nausea, dizziness, enuresis, headache, and vomiting. Highlights from the presentations of new data presented at the meeting include: End-of-study survey data from the RESTORE open-label/switch study demonstrating that patients experienced a high level of satisfaction with once-at-bedtime LUMRYZ, including improved symptom control, an improvement in dosing adherence and a preference for LUMRYZ over twice-nightly oxybate treatment options. Findings from a human factor study revealing that individuals with narcolepsy, regardless of their prior experience with oxybate treatment, can successfully follow the label instructions for safe use of LUMRYZ. Data showing consistent and acceptable dissolution of LUMRYZ at prescribed doses in various flavored liquids, which may be preferred by some patients as alternatives to water. Post hoc analysis from Avadel’s completed pivotal REST-ON clinical trial that showed treatment with LUMRYZ improved symptoms of EDS and cataplexy in people with narcolepsy regardless of gender. A poster comparing baseline narcolepsy characteristics among three age groups (youngest: 16–25 years of age; middle: 26–34 years of age; oldest: 35–72 years of age) of participants from the REST-ON clinical trial which indicated that baseline measures of EDS were similar among age groups. Additionally, objective data from polysomnography showed worse disrupted nighttime sleep (DNS) in older participants, indicating DNS may worsen with age. Findings from a social listening analysis of content posted on MyNarcolepsyTeam, a social network for people with narcolepsy, which concluded that gaining a better understanding of patient experiences and self-management strategies enables sleep specialists to more effectively identify challenges and needs of patients, leading to quicker diagnoses and tailored treatments.お知らせ • May 10Avadel Pharmaceuticals plc has completed a Follow-on Equity Offering.Avadel Pharmaceuticals plc has completed a Follow-on Equity Offering. Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 1,768 Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 1,820 Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 1,564 Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 640 Transaction Features: At the Market Offeringお知らせ • May 09Avadel Pharmaceuticals plc has filed a Follow-on Equity Offering in the amount of $100 million.Avadel Pharmaceuticals plc has filed a Follow-on Equity Offering in the amount of $100 million. Security Name: Ordinary Shares Security Type: Common Stock Transaction Features: At the Market Offeringお知らせ • May 03Avadel Pharmaceuticals plc to Report Q1, 2024 Results on May 08, 2024Avadel Pharmaceuticals plc announced that they will report Q1, 2024 results on May 08, 2024Board Change • Apr 18Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Mark McCamish was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.収支内訳Avadel Pharmaceuticals の稼ぎ方とお金の使い方。LTMベースの直近の報告された収益に基づく。収益と収入の歴史DB:AWK 収益、費用、利益 ( )USD Millions日付収益収益G+A経費研究開発費30 Sep 2524901974030 Jun 25221-31851731 Mar 25194-261781631 Dec 24169-491811530 Sep 24138-731721330 Jun 2495-1061711231 Mar 2455-1571761231 Dec 2328-1601521330 Sep 239-1591271730 Jun 231-1431021731 Mar 230-142771831 Dec 220-137752130 Sep 220-132791730 Jun 220-134861831 Mar 220-90792031 Dec 210-77681730 Sep 210-66562030 Jun 210-56442131 Mar 2110-6361931 Dec 20227322030 Sep 203316312330 Jun 204818282531 Mar 2055-21283131 Dec 1959-33303330 Sep 1969-94463130 Jun 1975-101653531 Mar 1986-96863731 Dec 18103-951003930 Sep 18117-401016630 Jun 18137-2885431 Mar 1815430734231 Dec 1717368593330 Sep 171828146030 Jun 171744048031 Mar 17167-947031 Dec 16150-41453430 Sep 161522840030 Jun 161671932031 Mar 161772327031 Dec 151734222030 Sep 15127-6419030 Jun 1587-4618031 Mar 1543-49170質の高い収益: AWKは現在利益が出ていません。利益率の向上: AWKは現在利益が出ていません。フリー・キャッシュフローと収益の比較過去の収益成長分析収益動向: AWKは利益が出ておらず、過去 5 年間で損失は年間5.9%の割合で増加しています。成長の加速: AWKの過去 1 年間の収益成長を 5 年間の平均と比較することはできません。現在は利益が出ていないためです。収益対業界: AWKは利益が出ていないため、過去 1 年間の収益成長をPharmaceuticals業界 ( 15.3% ) と比較することは困難です。株主資本利益率高いROE: AWKは現在利益が出ていないため、自己資本利益率 ( -0.28% ) はマイナスです。総資産利益率使用総資本利益率過去の好業績企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 、過去の業績が好調な企業。View Financial Health企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/02/16 11:30終値2026/02/12 00:00収益2025/09/30年間収益2024/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Avadel Pharmaceuticals plc 6 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。8 アナリスト機関James MolloyBrean Capital Historical (Janney Montgomery)Jason ButlerCitizens JMP Securities, LLCChase KnickerbockerCraig-Hallum Capital Group LLC5 その他のアナリストを表示
お知らせ • Jul 31Avadel Pharmaceuticals plc to Report Q2, 2025 Results on Aug 07, 2025Avadel Pharmaceuticals plc announced that they will report Q2, 2025 results on Aug 07, 2025
お知らせ • Apr 30Avadel Pharmaceuticals plc to Report Q1, 2025 Results on May 07, 2025Avadel Pharmaceuticals plc announced that they will report Q1, 2025 results on May 07, 2025
お知らせ • Feb 25Avadel Pharmaceuticals plc to Report Q4, 2024 Results on Mar 03, 2025Avadel Pharmaceuticals plc announced that they will report Q4, 2024 results on Mar 03, 2025
Reported Earnings • Nov 13Third quarter 2024 earnings released: US$0.027 loss per share (vs US$0.41 loss in 3Q 2023)Third quarter 2024 results: US$0.027 loss per share (improved from US$0.41 loss in 3Q 2023). Revenue: US$50.0m (up US$43.0m from 3Q 2023). Net loss: US$2.63m (loss narrowed 93% from 3Q 2023). Revenue is forecast to grow 29% p.a. on average during the next 3 years, compared to a 3.5% growth forecast for the Pharmaceuticals industry in Germany.
お知らせ • Nov 04Avadel Pharmaceuticals plc to Report Q3, 2024 Results on Nov 12, 2024Avadel Pharmaceuticals plc announced that they will report Q3, 2024 results on Nov 12, 2024
お知らせ • Aug 02Avadel Pharmaceuticals plc to Report Q2, 2024 Results on Aug 08, 2024Avadel Pharmaceuticals plc announced that they will report Q2, 2024 results on Aug 08, 2024
お知らせ • Feb 14Avadel Pharmaceuticals plc(NasdaqGM:AVDL) dropped from NASDAQ Composite IndexAvadel Pharmaceuticals Limited has been dropped from the NASDAQ Composite Index.
お知らせ • Feb 12+ 21 more updatesAvadel Pharmaceuticals plc Announces Board of Director ChangesAvadel Pharmaceuticals plc announced that Additionally, as of the Effective Time, each of Geoffrey M. Glass, Gregory J. Divis, Dr. Eric J. Ende, Dr. Mark A. McCamish, Linda S. Palczuk, Peter J. Thornton and Dr. Naseem S. Amin ceased serving as a member of the board of directors of Avadel and each committee thereof on which such director served.
お知らせ • Dec 18Avadel Pharmaceuticals plc Announces Completion of Enrollment in Phase 3 REVITALYZ Trial in Idiopathic HypersomniaAvadel 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.
お知らせ • Nov 14H. 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.
お知らせ • Oct 22+ 1 more updateAlkermes plc (NasdaqGS:ALKS) entered into a definitive agreement to acquire Avadel Pharmaceuticals plc (NasdaqGM:AVDL) for $1.8 billion.Alkermes plc (NasdaqGS:ALKS) entered into a definitive agreement to acquire Avadel Pharmaceuticals plc (NasdaqGM:AVDL) for $1.8 billion on October 22, 2025. Transaction Valued at $18.50 per Share in Cash with a CVR for an Additional $1.50 per Share in Cash, for Total Consideration of up to $20.00 per share Subject and pursuant to the terms of the CVR Agreement, each CVR will represent the contractual right to receive the Milestone Payment upon the occurrence of each of: approval by the United States Food and Drug Administration (the "FDA") of an application submitted to the FDA for the commercial marketing and sale of the CVR Product in the United States for the Indication; provided, that, such approval shall be deemed achieved upon receipt of written notice from the FDA that the CVR Product has been approved for the Indication in the United States and which is not blocked by any third party orphan-drug exclusivity, regardless of whether any risk evaluation and mitigation strategies or other conditions are imposed by the FDA ("LUMRYZ Approval"); and the dismissal of the Claims with prejudice by the United States District Court for the District of Delaware pursuant to the Settlement and License Agreement, by and between Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited, on the one hand, and Avadel CNS Pharmaceuticals LLC and Flamel Ireland Limited, on the other hand, dated October 21, 2025 between the Company and Jazz Pharmaceuticals, Inc. (such occurrence, the "Legal Event," and together with LUMRYZ Approval, the "Milestone"). If the Milestone is not achieved by the Milestone Expiration, then the CVRs will have no value. The minimum payment under each CVR is zero; if the Milestone Payment is made, the payment under each CVR is $1.50. It is intended that, subject to and following the Scheme becoming effective, and subject to applicable laws and rules and policies of Nasdaq, the Company Shares will be delisted from the Nasdaq Global Market and deregistered, along with any other Company securities registered under the Exchange Act, if any, as promptly as practicable after the Effective Time. As a result of the Scheme, Avadel will become a wholly owned subsidiary of Alkermes. Alkermes reserves the right, subject to the terms of the Transaction Agreement, to elect to implement the Acquisition by way of a takeover offer (as such term is defined in the Irish Takeover Rules) rather than the Scheme. The Bridge Credit Agreement provides for a senior secured bridge term loan facility (the “Bridge Credit Facility”) in an aggregate principal amount of up to $1,231,459,813.22 that is available to finance the payment of Cash Consideration and fees and expenses related to the Acquisition. Following Completion, the global headquarters of the Combined Group will be located at Alkermes' current global headquarters in Dublin, Ireland. Alkermes will, as part of its review of the Company's business referred to above, evaluate the consolidation of some or all of the Company's locations of business, including functions currently undertaken at the Company's U.S. headquarters in St. Louis, Missouri, into Alkermes' global headquarters in Dublin, Ireland and other locations of Alkermes across the United States. The Acquisition is subject to the satisfaction or waiver (as applicable) of the Conditions, which are set out in full in Appendix III (Conditions of the Acquisition and the Scheme) to this Announcement, including, in summary the approval by the Company Shareholders of the Scheme; the sanction by the High Court of the Scheme; the receipt of required antitrust Clearances in the United States; the Transaction Agreement not having been terminated in accordance with its terms; the absence of a Company Material Adverse Effect that is continuing; the absence of a Parent Material Adverse Effect that is continuing; the accuracy of each of the Parties' representations and warranties, except generally as would not have a material adverse effect on such Party; and the performance by each Party, in all material respects, with all of its covenants and agreements under the Transaction Agreement. The transaction is expected to close in the first quarter of 2026. The board of directors of Avadel Pharmaceuticals has unanimously determined that the Acquisition by Alkermes is in the best interests of all Shareholders and has unanimously approved the Acquisition. The Acquisition has also been approved by the board of directors of Alkermes. The transaction is expected to be immediately accretive upon closing and represents a compelling financial and strategic opportunity, leveraging Alkermes' existing commercial expertise and operational infrastructure and adding new capabilities in rare disease. The transaction is expected to be immediately accretive upon closing and represents a compelling financial and strategic opportunity, leveraging Alkermes' existing commercial expertise and operational infrastructure and adding new capabilities in rare disease. Jeremy Meilman, Andy Ham Dwayne Lysaght and Edward Hatter of J.P. Morgan Securities LLC and J.P. Morgan Securities plc acted as financial advisors, James E.Langston; and Chelsea N. Darnell of Paul, Weiss, Rifkind, Wharton & Garrison LLP and Stephen FitzSimons and Jack Kelly of McCann FitzGerald LLP acted as legal advisors for Alkermes plc. Cleary Gottlieb Steen & Hamilton LLP is acting as legal counsel to Alkermes for the financing. Peter van der Goes, Ryan Fisk and Emily West Warren Stables of Goldman Sachs & Co. LLC, Tedd Smith, Daniel Cohen, David Kitterick and Ben Nassau of Morgan Stanley & Co. International plc and Morgan Stanley & Co. LLC acted as financial advisors, while Robert Puopolo, Blake Liggio, Caitlin Tompkins, and Stephanie Isaia of Goodwin Procter LLP and Christopher McLaughlin; and David Vos of Arthur Cox LLP acted as legal advisors for Avadel Pharmaceuticals plc. Goldman Sachs & Co. LLC and Morgan Stanley & Co. LLC acted as fairness opinion providers for Avadel Pharmaceuticals plc.
お知らせ • Sep 05Avadel Pharmaceuticals plc to Present New Data on LUMRYZ (sodium Oxybate) for Extended-Release Oral Suspension at World Sleep 2025Avadel 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.
お知らせ • Aug 07+ 1 more updateAvadel Pharmaceuticals plc Raises Revenue Guidance for the Full Year of 2025Avadel Pharmaceuticals plc raised revenue guidance for the full year of 2025. For the year, the company expects revenue to be between $265 million to $275 million.
お知らせ • Jul 31Avadel Pharmaceuticals plc to Report Q2, 2025 Results on Aug 07, 2025Avadel Pharmaceuticals plc announced that they will report Q2, 2025 results on Aug 07, 2025
お知らせ • Jul 14ASL Strategic Value Fund Files an Exempt Solicitation Statement with Securities and Exchange CommissionOn July 14, 2025, ASL Strategic Value Fund LP announced that it has filed an exempt solicitation statement with Securities and Exchange Commission, recommended the shareholders of Avadel Pharmaceuticals plc to vote against the Company board nominees and call on the Company to appoint an independent election monitor to oversee the Annual Meeting vote, subject to shareholder approval, at the annual meeting of shareholders scheduled to be held on July 29, 2025.
お知らせ • Jul 02ASL Strategic Value Fund Issues Open Letter to Avadel ShareholdersOn June 30, 2025, ASL Strategic Value Fund, LP announced that it has issued an open letter calling on Avadel Pharmaceuticals plc’s shareholders to vote against all of the Company’s director nominees up for election at the 2025 annual general meeting of shareholders scheduled for July 29, 2025.ASL Strategic Value stated that it has sent its previous letter previous letter to the Company’s board of directors dated February 10, 2025, where it has called on the Board to embark on a new course of action designed to maximize the Company’s value for all long-suffering shareholders to which the Board has failed to appropriately respond. ASL Strategic Value added that it has called on the Board to retain an investment bank to monetize the significant value inherent in the Company’s best-in-class asset LUMRYZ which has been found by the U.S. Food and Drug Administration on two separate occasions to be "clinically superior" to any other sodium oxybate, just last week the FDA granted orphan drug designation for LUMRYZ for a new indication idiopathic hypersonia. The regulatory pathway for an IH approval is now quite clear, and if approved by the FDA, this additional indication could add an additional $500 million to $1 billion to the Company’s annual revenues.ASL Strategic Value stated that in its letter to the Board, dated May 14, 2025, it had negative experience in a prior the Company director election with ASL Strategic Value Fund's votes being improperly counted. In that election it approximately 1.28 million shares, which were voted against each director were not counted or disclosed in the final vote count. It was only after ASL Strategic counsel had contacted the Company about this serious omission that a corrective 8-K was later quietly filed with a corrected vote count, so to ensure that the vote at the upcoming election is fair and honest, it has called for an impartial election monitor to be appointed (with the approval of the shareholders).
お知らせ • Jun 30Avadel Pharmaceuticals Announces Unanimous Appeals Court Decision Upholding FDA Approval of LUMRYZ in Narcolepsy in Administrative Procedure Act LitigationAvadel Pharmaceuticals plc announced that, on June 27, 2025, the U.S. Court of Appeals for the District of Columbia Circuit (the Appeals Court) affirmed a prior decision of the U.S. District Court for the District of Columbia (the District Court) in favor of the U.S. Food and Drug Administration (FDA) in a suit brought by Jazz Pharmaceuticals Inc. (Jazz) regarding the FDA’s approval of LUMRYZTM, the first and only once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. Following the District Court’s ruling in favor of the FDA and Avadel in October 2024, which granted the FDA’s Motions for Summary Judgment with respect to Jazz’s complaint and denied Jazz’s Motion for Summary Judgment, Jazz filed a notice of appeal to the Appeals Court. On June 27, 2025, the Appeals Court, in a unanimous panel decision, affirmed the District Court’s ruling and upheld the FDA’s approval of LUMRYZ.
お知らせ • Jun 19Avadel Pharmaceuticals plc, Annual General Meeting, Jul 29, 2025Avadel Pharmaceuticals plc, Annual General Meeting, Jul 29, 2025. Location: arthur cox llp, ten earlsfort terrace, dublin 2, d02 t380, Ireland
お知らせ • May 30Avadel Pharmaceuticals plc to Present New Data on LUMRYZ™? (sodium Oxybate) for Extended-Release Oral Suspension at Sleep 2025Avadel Pharmaceuticals plc announced that new data supporting the use of LUMRYZ as a narcolepsy treatment and additional data to better understand the real-life experience of people living with narcolepsy will be presented in four oral presentations and 14 posters at SLEEP 2025, the 39th Annual Meeting of the Associated Professional Sleep Societies (APSS), taking place June 8-11, 2025 in Seattle. Post-hoc analysis of the pivotal Phase 3 REST-ON clinical trial, restricted to those study participants with the most severe sleepiness at baseline as measured both objectively and subjectively, showed LUMRYZ participants with a median Epworth Sleepiness Scale (ESS) score at Week 13 that was improved to the range at or below that considered normal. Highlights from the presentations at SLEEP 2025 include: Interim REFRESH results demonstrating that among 67 patients (approximately half oxybate naïve, 37% switches from twice-nightly oxybates, and the remainder previous twice-nightly oxybate users); patients in all groups achieved clinically significant reductions in sleepiness, with normal ESS scores after starting LUMRYZ. A post-hoc analysis restricted to the most severely sleepy tertiles at baseline in REST-ON; at the end of the study, median ESS was at or below the normal threshold with LUMRYZ. A post-hoc analysis from REST-ON to quantify hypnagogic and hypnopompic hallucinations (HH) during the trial; these aggregate data show that LUMRYZ participants reported approximately half as many HH events where they felt like they were going to be attacked, flying through the air, or falling into a hole compared to placebo. A post-hoc analysis from REST-ON demonstrating consistency of LUMRYZ efficacy across objective and subjective disrupted nighttime sleep outcomes in various subgroups (e.g., narcolepsy type 1 or 2, male or female, stimulant use). A retrospective chart analysis of patients with sleep-related eating disorder (SRED) while on twice-nightly oxybates, which was ameliorated after switching to LUMRYZ. A post hoc analysis from the stable dosing period of the RESTORE open-label study evaluating 115 participants (median treatment: 503 days) who switched from twice-nightly oxybate to LUMRYZ; side effects were consistent with the known adverse events of oxybates and only 4% of participants discontinued LUMRYZ due to a treatment-related adverse event, underscoring the long-term tolerability of LUMRYZ. A survey conducted in collaboration with MyNarcolepsyTeam of 88 respondents, revealing the need for enhanced patient-clinician discussions of oxybates as a treatment option, as well as better setting of oxybate treatment expectations to minimize discontinuations, particularly as they relate to side effects that are generally transient in nature.
お知らせ • May 07Avadel Pharmaceuticals plc Raises Earnings Guidance for the Full Year 2025Avadel Pharmaceuticals plc announced that it Raises 2025 full year guidance to $255 - $265 million in net product revenue.
お知らせ • May 06Avadel Pharmaceuticals Announces Favorable Ruling in Appeal of Delaware Court InjunctionAvadel Pharmaceuticals plc announced that the United States Court of Appeals for the Federal Circuit (the “Federal Circuit”) has ruled in favor of Avadel, overturning important parts of the injunction imposed by the U.S. District Court for the District of Delaware (the “Delaware Court”) regarding LUMRYZ™ as a potential treatment of indications beyond narcolepsy. The Federal Circuit vacated the portion of the injunction that prohibited Avadel from applying for FDA approval of LUMRYZ for any indication beyond narcolepsy, calling the district court’s analysis “simply too speculative and tenuous.” Additionally, the Federal Circuit lifted the portions of the Delaware Court's injunction that prohibited Avadel from offering open-label extensions to trial participants using LUMRYZ and from initiating new clinical trials or studies with LUMRYZ for potential indications beyond narcolepsy. Patient enrollment in Avadel’s REVITALYZ™ trial remains on track to be completed by the end of 2025. REVITALYZ is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 study designed to evaluate the efficacy and safety of LUMRYZ given as a once-at-bedtime dose, in IH. The study will enroll approximately 150 adults who are diagnosed with IH and is open for participants switching from immediate-release oxybates and to those not currently taking oxybates.
お知らせ • Apr 30Avadel Pharmaceuticals plc to Report Q1, 2025 Results on May 07, 2025Avadel Pharmaceuticals plc announced that they will report Q1, 2025 results on May 07, 2025
お知らせ • Apr 17Avadel and nference Announce Publication of Real-World Data on Sodium Oxybate Treatment Patterns in the Journal of Clinical NeuroscienceAvadel Pharmaceuticals plc and nference announced the publication of real-world data on comorbidities and treatment patterns of people with narcolepsy treated versus not treated with immediate-release sodium oxybate. The paper, titled " Characterization and Treatment patterns of Patients Treated With Immediate-Release Sodium oxybate for Narcolepsy: A Propensity-Matched Cohort Study," was published online in the Journal of Clinical Neuroscience. A review of de-identified electronic health records (EHR) from patients at Mayo Clinic identified 4,387 individuals living with narcolepsy, of whom 351 had received immediate-release sodium oxybates treatment. This cohort of 351 patients with narcolepsy treated with sodium oxybate was age/sex matched with a cohort of 351 patients with narColepsy without sodium oxybate treatment. The retrospective analysis was conducted through Mayo Clinic's Clinical Data Analytics Platform, which leverages nference's AI software to provide access to curated, deidentified electronic health data in a secure, privacy-protected environment. These types of data provide a more comprehensive view of patient information than claims data alone. Other relevant findings included high rates of insomnia in both groups (approximately 43%), reflecting the frequent disruptive nighttime sleep inherent in narcolepsy," said Melissa Lipford, M.D., a neurologist at the Center for Sleep Medicine at Mayo Clinic and lead author of the published paper. The high rate of idiopathic hypersomnia (IH) diagnosis underscores the challenges with identifying between narcolepsy and IH based upon current testing. These findings also revealed insights into challenges with middle-of-the-night sodium oxybate dosing and lessened efficacy when the second dose wasomitted.
お知らせ • Mar 25Avadel Pharmaceuticals plc Announces Publications in CNS Drugs Supplement Highlighting Key Clinical Issues for People with Narcolepsy and Their CliniciansAvadel Pharmaceuticals plc announced the publication of six manuscripts covering clinical management, shared decision-making and goal setting for people with narcolepsy and their clinicians in a CNS Drugs supplement titled "A New Dawn in the Management of Narcolepsy". Summary of Papers in CNS Drugs Supplement: Narcolepsy: Beyond the Classic Pentad Authored by Anne Marie Morse, D.O., Director of Pediatric Neurology at Geisinger Medical Center and others, this paper addresses the full 24-hour impact and symptom burden that patients experience, as well as the need for an individualized treatment approach and care considerations that extend beyond the hallmark features of the disease. A Survey of People Living With Narcolepsy in the USA: Path to Diagnosis, Authored by Luis E. Ortiz, M.D., Assistant Professor of Pediatrics at Johns Quality of Life, and Treatment Landscape From the Patient's Perspective Hopkins Medicine and others, the survey reports data from 110 people living with narcolepsy. Among the key findings: nearly three-fourths (72%) of responders experienced some form of nighttime sleep disturbance (such as disrupted nighttime sleep and fragmented sleep) and approximately one-third (33%) of sodium oxybate users reported their top treatment goal was medicine to help them sleep through the night. Sodium Oxybate: Practical Considerations and Patient Perspectives Authored by Maggie Lavender, M.S.N., of Comprehensive Sleep Medicine Associates in Houston, Texas and others, this paper includes illustrative clinical case scenarios of two people with narcolepsy, providing clinicians with a proposed framework to optimize discussions with patients and certify sodium oxybate treatment, providing practical tips and support for initiating and maintaining therapy.
お知らせ • Mar 03Avadel Pharmaceuticals Reiterates Earnings Guidance for the Year 2025Avadel Pharmaceuticals reiterated earnings Guidance for the year 2025. For the period, the company expects to generate $240 million to $260 million in net product revenue as the number of patients on LUMRYZ is expected to grow to 3,300 to 3,500.
お知らせ • Feb 25Avadel Pharmaceuticals plc to Report Q4, 2024 Results on Mar 03, 2025Avadel Pharmaceuticals plc announced that they will report Q4, 2024 results on Mar 03, 2025
お知らせ • Jan 09+ 1 more updateAvadel Pharmaceuticals plc Provides Update on Revitalyz Pivotal StudyAvadel Pharmaceuticals plc provided update on REVITALYZ pivotal study. the company announced that patient enrollment is ongoing in the REVITALYZ pivotal study, a Phase 3 double-blind, placebo-controlled, randomized withdrawal, multicenter study designed to evaluate the efficacy and safety of LUMRYZ in IH. Completion of this study is expected during the second half of 2025. Preclinical development ongoing for a once-nightly, low-/no-sodium oxybate formulation with a target product profile bioequivalent to LUMRYZ.
お知らせ • Dec 04Avadel Pharmaceuticals plc Announces Step Down of Richard Kim as Chief Commercial Officer Effective as of December 31, 2024On December 2, 2024, Richard Kim notified Avadel Pharmaceuticals plc (the Company) that he will step down as Chief Commercial Officer effective as of December 31, 2024.
Reported Earnings • Nov 13Third quarter 2024 earnings released: US$0.027 loss per share (vs US$0.41 loss in 3Q 2023)Third quarter 2024 results: US$0.027 loss per share (improved from US$0.41 loss in 3Q 2023). Revenue: US$50.0m (up US$43.0m from 3Q 2023). Net loss: US$2.63m (loss narrowed 93% from 3Q 2023). Revenue is forecast to grow 29% p.a. on average during the next 3 years, compared to a 3.5% growth forecast for the Pharmaceuticals industry in Germany.
お知らせ • Nov 04Avadel Pharmaceuticals plc to Report Q3, 2024 Results on Nov 12, 2024Avadel Pharmaceuticals plc announced that they will report Q3, 2024 results on Nov 12, 2024
お知らせ • Oct 26Avadel Pharmaceuticals and nference, Inc. Publish Real-World Data on Narcolepsy in Sleep AdvancesAvadel Pharmaceuticals plc and nference announced the publication of real-world data that identified the demographic characteristics and the top 20 most prevalent comorbidities of people living with narcolepsy. The paper, titled “Demographic Characteristics and Comorbidities of Patients With Narcolepsy: A Propensity-Matched Cohort Study,” was published online in Sleep Advances. These real-world findings were previously presented at the American Neurological Association (ANA) Annual Meeting in October 2022. Results describing demographic characteristics and the top 20 comorbidities were based on a review of deidentified electronic health data from more than 2,000 people with narcolepsy and 2,000 matched controls. The retrospective analysis was conducted through Mayo Clinic Platform, which leverages nference’s AI software to provide access to curated, deidentified electronic health data in a secure, privacy-protected environment. These types of data provide a more comprehensive view of patient information than claims data alone.
お知らせ • Oct 17Avadel Pharmaceuticals Announces FDA Approval of LUMRYZ (sodium oxybate) Extended-Release Oral Suspension (CIII) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Patients 7 Years of Age and Older with NarcolepsyAvadel Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for LUMRYZ for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. This approval represents an important milestone for the narcolepsy community, specifically for younger narcolepsy patients and their caregivers who face significant challenges associated with waking up in the middle of the night to complete treatment regimens. Symptoms of narcolepsy are EDS and may also include a sudden loss of muscle tone usually triggered by strong emotion (cataplexy), disrupted nighttime sleep, sleep paralysis and hallucinations when falling asleep or waking up. LUMRYZ is a once-at-bedtime formulation extended-release sodium oxybate and was first approved by the FDA on May 1, 2023, for the treatment of catap Flexy or EDS in adult patients with narcolepsy. LUMRYZ was approved by the FDA for use in the treatment of cataplexY or EDS in the pediatric narcolepsy population 7 years and older on October 16, 2024, and was granted Orphan Drug Exclusivity through October 16, 2031. LUMRYZ has a boxed warning as a central nervous system depressant, and for its potential for abuse and misuse. LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the LUMRYZ REMS. Most common adverse reactions (incidence > 5% and greater than placebo) reported for all doses of LUMRYZ combined in a trial of adults with narcolepsy were nausea, dizziness, enuresis, headache, and vomiting. LUMRYZ is an extended-release sodium oxybates medication approved by the FDA on May1, 2023, as the first and only once-at-bedtime treatment for cataplexy or E DS 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 approval in May 2023, the FDA also granted 7 years of Orphan Drug Exclusivity to LUMRYZ for thetreatment of cataplexy orEDS in adults with narcole epilepsy 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. Avadel's commercial product, LUMRYZ, was approved by the FDA's commercial product, LUMryZ, was approved by the company's commercial product, LUMYZ, was approved by the Company's commercial product, LumRYZ, was approved by The Company's commercial product, LUMRIZ, was approved by the company's commercial product.
お知らせ • Sep 04Avadel Pharmaceuticals plc Announces Publication of Restore Data Highlighting Challenges with Twice-Nightly Oxybates and Strong Patient Preference for Once-Nightly LUMRYZ Dosing (sodium Oxybate) Extended-Release Oral Suspension (CIII)Avadel Pharmaceuticals plc announced the publication of final data from the RESTORE open-label/switch study, demonstrating that people with narcolepsy prefer once-at-bedtime LUMRYZ versus a twice-nightly immediate-release oxybate treatment option. The U.S. Food and Drug Administration approved LUMRYZ in 2023 as the first and only once-nightly oxybate, which marked a significant milestone for people with narcolepsy, as twice-nightly oxybates were the only other oxybate options available for more than 20 years. Initial and end-of-study survey data from RESTORE were previously presented in April 2022 at the American Academy of Neurology Annual Meeting and in June 2024 at SLEEP 2024. Of the 129 switch participants who completed the nocturnal adverse events questionnaire at baseline: 69% reported missing their second oxybate dose, and of those participants, 80% felt that control of their symptoms was worse the next day compared to days after which they had taken both doses as prescribed. More than half (51%) of the 51 participants who took their second nightly oxybate dose more than four hours after the first dose reported feeling somewhat to extremely groggy or unsteady the next morning. 92% reported getting out of bed after taking their second dose of oxybate, with 7.5% of those reporting falling after waking up for the second dose, and 4.2% reporting injuries. 23% of participants stated they required another person to wake with them in the middle of the night to ensure they took the second dose of their twice-nightly oxybate dosing. Of the 68 switch participants who completed the end-of-study questionnaire: 79% were very satisfied with LUMRYZ compared to other narcolepsy treatments they had previously taken. 93% would recommend LUMRYZ to a family member or friend with narcolepsy. 91% said they were better able to sleep through the night since starting treatment with LUMRYZ. 91% said they were best able to follow the recommended medication schedule of LUMRYZ than their previous oxybate.
New Risk • Sep 01New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$114m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. This is currently the only risk that has been identified for the company.
お知らせ • Aug 20Avadel Pharmaceuticals plc Announces Publication in Clinical Therapeutics of Data Highlighting Weight Loss in People with Narcolepsy Treated with LUMRYZ™ (sodium oxybate) Extended-Release Oral SuspensionAvadel Pharmaceuticals plc announced the publication of results of a post-hoc analysis from the completed pivotal Phase 3 REST-ON clinical trial demonstrating greater weight loss in patients who received LUMRYZ compared with placebo. The paper, titled " weight Loss With Once-nightly Sodium oxybate for the Treatment of Narcolepsy: Analysis From the Phase III Randomized study Evaluating the efficacy and SafeTy of a ONce nightly formulation of sodium oxybate (REST-ON) Trial," was published online in Clinical Therapeutics. A significant reduction in BMI was observed after 13 weeks of treatment with LUMRYZ versus placebo, with a between-group difference in least squares mean change from baseline of 0.59 kg/m2 (p=0.001). In the weight loss group, participants shifted from obese into overweight, and from overweight into normal weight during this trial; no participants were underweight. 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. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS, clinicians' overall assessment of patients' functioning (CGI-I), and cataplexy attacks, for all three evaluated doses when compared to placebo. With its approval, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcole epilepsy 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.
New Risk • Aug 09New minor risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow. Free cash flow: -US$114m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. This is currently the only risk that has been identified for the company.
お知らせ • Aug 02Avadel Pharmaceuticals plc to Report Q2, 2024 Results on Aug 08, 2024Avadel Pharmaceuticals plc announced that they will report Q2, 2024 results on Aug 08, 2024
お知らせ • Aug 01Avadel Pharmaceuticals plc Announces First Patient Dosed in Phase 3 REVITALYZ Trial of LUMRYZ (sodium oxybate) Extended-Release Oral Suspension for the Treatment of Idiopathic HypersomniaAvadel Pharmaceuticals plc announced that the first patient has been dosed in REVITALYZ, a Phase 3 study evaluating LUMRYZ as a potential treatment for idiopathic hypersomnia (IH). REVITALYZ is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 study designed to evaluate the efficacy and safety of LUMRYZ given as a once-at-bedtime dose, in IH. The study will enroll approximately 150 adults who are diagnosed with IH and includes an open label extension portion. REVITALYZ enrollment is open for both participants switching from immediate-release oxybates and not currently taking oxybates. The primary objective of REVITALYZ is to demonstrate reduction in daytime sleepiness as measured by the primary endpoint, change in total score of the Epworth Sleepiness Scale (ESS) at Week 14. Secondary endpoints will evaluate the effect of LUMRYZ on additional efficacy parameters including patient and clinician impression of change, idiopathic hypersomnia severity, and a measure of the functional outcomes of sleep. 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 narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS, clinicians’ overall assessment of patients’ functioning (CGI-I), and cataplexy attacks, for all three evaluated doses when compared to placebo.?With its approval, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy 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.
お知らせ • Jun 20Avadel Pharmaceuticals plc, Annual General Meeting, Jul 30, 2024Avadel Pharmaceuticals plc, Annual General Meeting, Jul 30, 2024. Location: arthur cox llp, ten earlsfort terrace, d02 t380, dublin 2, Ireland
お知らせ • May 24Avadel Pharmaceuticals plc Appoints Naseem Amin to Its Board of DirectorsAvadel Pharmaceuticals plc announced the appointment of Naseem Amin, M.D. to its board of directors, effective May 17, 2024. Dr. Amin, a highly successful executive who brings global industry and leadership experience to Avadel, currently serves as Chief Executive Officer of Orphalan SA. Dr. Amin brings to Avadel thirty years of international industry executive leadership and expertise in business development, venture capital, and research and development. He is currently Chief Executive Officer of Orphalan SA, a role he has held since June 2017. Dr. Amin previously served as Executive Chairman at Arix Bioscience plc, until April 2021, and was Venture Partner at Advent Life Sciences until 2020. Earlier, he was the Chief Scientific Officer at Smith and Nephew until 2014, overseeing corporate R&D, divisional manufacturing, and product development functions. Previous to that, Dr. Amin was Senior Vice President, Business Development, at Biogen Idec from 2005 to 2009, was with Genzyme Corporation from 1999 to 2005, and began his career at Baxter Healthcare Corporation. Dr. Amin received his medical degree from the Royal Free School of Medicine, London, and his MBA from the Kellogg Graduate School of Management, Northwestern University.
お知らせ • May 23Avadel Pharmaceuticals Shares New LUMRYZ (sodium Oxybate) for Extended-Release Oral Suspension (CIII) Data at Sleep 2024Avadel Pharmaceuticals plc announced it will present 11 posters, and one oral presentation, supporting the use of LUMRYZ as a narcolepsy treatment option at SLEEP 2024, the 38th annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society on June 1-5, 2024, in Houston. Approved by the U.S. Food and Drug Administration (FDA) in 2023, LUMRYZ is the first and only extended-release formulation of sodium oxybate and indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. LUMRYZ has a boxed warning as a central nervous system depressant, and for its potential for abuse and misuse. LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the LUMRYZ REMS. Most common adverse reactions (incidence >5% and greater than placebo) reported for all doses of LUMRYZ combined were nausea, dizziness, enuresis, headache, and vomiting. Highlights from the presentations of new data presented at the meeting include: End-of-study survey data from the RESTORE open-label/switch study demonstrating that patients experienced a high level of satisfaction with once-at-bedtime LUMRYZ, including improved symptom control, an improvement in dosing adherence and a preference for LUMRYZ over twice-nightly oxybate treatment options. Findings from a human factor study revealing that individuals with narcolepsy, regardless of their prior experience with oxybate treatment, can successfully follow the label instructions for safe use of LUMRYZ. Data showing consistent and acceptable dissolution of LUMRYZ at prescribed doses in various flavored liquids, which may be preferred by some patients as alternatives to water. Post hoc analysis from Avadel’s completed pivotal REST-ON clinical trial that showed treatment with LUMRYZ improved symptoms of EDS and cataplexy in people with narcolepsy regardless of gender. A poster comparing baseline narcolepsy characteristics among three age groups (youngest: 16–25 years of age; middle: 26–34 years of age; oldest: 35–72 years of age) of participants from the REST-ON clinical trial which indicated that baseline measures of EDS were similar among age groups. Additionally, objective data from polysomnography showed worse disrupted nighttime sleep (DNS) in older participants, indicating DNS may worsen with age. Findings from a social listening analysis of content posted on MyNarcolepsyTeam, a social network for people with narcolepsy, which concluded that gaining a better understanding of patient experiences and self-management strategies enables sleep specialists to more effectively identify challenges and needs of patients, leading to quicker diagnoses and tailored treatments.
お知らせ • May 10Avadel Pharmaceuticals plc has completed a Follow-on Equity Offering.Avadel Pharmaceuticals plc has completed a Follow-on Equity Offering. Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 1,768 Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 1,820 Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 1,564 Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 640 Transaction Features: At the Market Offering
お知らせ • May 09Avadel Pharmaceuticals plc has filed a Follow-on Equity Offering in the amount of $100 million.Avadel Pharmaceuticals plc has filed a Follow-on Equity Offering in the amount of $100 million. Security Name: Ordinary Shares Security Type: Common Stock Transaction Features: At the Market Offering
お知らせ • May 03Avadel Pharmaceuticals plc to Report Q1, 2024 Results on May 08, 2024Avadel Pharmaceuticals plc announced that they will report Q1, 2024 results on May 08, 2024
Board Change • Apr 18Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Mark McCamish was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.