Aankondiging • Feb 14
Avadel Pharmaceuticals plc(NasdaqGM:AVDL) dropped from NASDAQ Composite Index Avadel Pharmaceuticals Limited has been dropped from the NASDAQ Composite Index. Aankondiging • Dec 18
Avadel Pharmaceuticals plc Announces Completion of Enrollment in Phase 3 REVITALYZ Trial in Idiopathic Hypersomnia Avadel Pharmaceuticals plc announced the completion of patient enrollment in REVITALYZ, a Phase 3 trial evaluating LUMRYZTM (sodium oxybate) extended-release oral suspension as a potential treatment for idiopathic hypersomnia (IH). The trial is evaluating study participants switching from immediate-release oxybates as well as those not currently taking oxybates. LUMRYZ is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. The FDA approval of LUMRYZ was supported by results from REST-ON™?, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcoleps. With its approvals in May 2023 and October 2024, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcole epilepsy and in pediatric patients seven years of age and older with narcolepsy respectively due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular, the FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose. In June 2025, the FDA granted Orphan Drug Designation to LUMRYZ for The treatment of IH based on the plausible hypothesis that LUMRYZ may be clinically superior to the same drug(s) already approved for the same indication, because LUMRYZ may provide a major contribution to patient care due to its once-nightly dosing for patients with IH, a chronic sleep disorder that requires potentially lifelong treatment. LUMRYZ is only currently approved for the treatment of catap Flexy or EDS in patients seven years of age and old with narcolepsy, and Avadel does not market, promote or offer patient support services for use of LUMRYZ in any indication beyond narcolepsy. Aankondiging • Nov 14
H. Lundbeck A/S (CPSE:HLUN B) submitted a non binding proposal to acquire Avadel Pharmaceuticals plc (NasdaqGM:AVDL) for $ 2.1 billion. H. Lundbeck A/S (CPSE:HLUN B) submitted a non binding proposal to acquire Avadel Pharmaceuticals plc (NasdaqGM:AVDL) for $ 2.1 billion on November 14, 2025. The transaction is valued at $21 per share in cash with a CVR for an Additional $2 per Share in Cash, for Total Consideration of up to $23 per share. CVR for an Additional $2 per Share in Cash comprises of $1.00 per ordinary share, contingent upon LUMRYZ and valiloxybate collectively reaching total annual net sales for end-use in the United States of at least $450 million in any calendar year by December 31, 2027 and $1 per ordinary share, contingent upon LUMRYZ and valiloxybate collectively reaching total annual net sales for end-use in the United States of at least $700 million in any calendar year by December 31, 2030. The deal is subject to approval of shareholders and board of Avadel Pharmaceuticals plc and regulatory approval. In a related transaction, Avadel entered into a definitive transaction agreement with Alkermes under which Alkermes will acquire all outstanding ordinary shares of Avadel for total purchase price of up to $20 per share.
Under the transaction agreement with Alkermes, the Avadel Board’s determination that the unsolicited Lundbeck Proposal would reasonably be expected to result in a Company Superior Proposal at this time allows Avadel to provide information to and conduct discussions and negotiations with Lundbeck, but does not allow Avadel to terminate its agreement with Alkermes or enter into any other agreement with Lundbeck. Avadel’s Board has not determined that the Lundbeck Proposal in fact constitutes a Company Superior Proposal under the existing transaction agreement with Alkermes and has not changed its recommendation in support of the Alkermes acquisition at this time.
Goldman Sachs & Co. LLC and Morgan Stanley & Co. LLC acted as financial advisors to Avadel Pharmaceuticals plc. Goodwin Procter LLP and Arthur Cox LLP acted as legal advisor to Avadel Pharmaceuticals plc. PJT Partners Inc. acted as financial advisor to H. Lundbeck A/S. Aankondiging • Sep 05
Avadel Pharmaceuticals plc to Present New Data on LUMRYZ (sodium Oxybate) for Extended-Release Oral Suspension at World Sleep 2025 Avadel Pharmaceuticals plc announced that new data supporting the use of LUMRYZ as a narcolepsy treatment will be presented in one oral presentation and 16 posters at World Sleep 2025, taking place September 5-10, in Singapore. Additional highlights from the presentations at World Sleep 2025 include: Updated and new results from an interim descriptive analysis of data from REFRESH (n=51), a prospective multicenter, real-world study in patients with narcolepsy, including those who switched to LUMRYZ from twice-nightly and those new to oxybate or returning to oxybate after discontinuing twice-nightly oxybate. Results showed that participants experienced clinically meaningful improvements in Epworth Sleepiness Scale (ESS) scores, a measure of excessive daytime sleepiness (EDS), to within the normal range. REFRESH study participants experienced a reduction in severity from moderate at the start of the study to mild at study end for the pentad of narcolepsy symptoms measured on the Narcolepsy Severity Scale (NSS) and reduced interference across domains on the Sheehan Disability Scale (SDS). After completing 4 months of therapy (switch participants, n=20; non-switch, n=31), 70% and 76% of switch participants and 90% and 87% of non-switch participants were improved on the Patient Global Impression of Change and the Clinician Global Impression of Change, respectively. Additional interim results from a study questionnaire and end of study survey showed that overall quality of life, fatigue, brain fog, depression, anxiety, and mood improved and as-needed use of stimulants was reduced. To characterize the comorbidities of patients with narcolepsy., an analysis of aggregate patient data from electronic health records (EHR) was conducted at Duke University. Results from 1,659 patients with narcolepsy and 1,659 matched controls showed sleep, pain and psychiatric or mood disorders occurred significantly more frequently in patients with Narcolepsy versus the control group (all p<0.1). LUMRYZ is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or EDS in adults with narcolepsy. On October 16, 2024, LUMRYZ was additionally approved as a once-at-time treatment for cataplexY or EDS in pediatric patients seven years of age and older with narcolepsy. The FDA approval of LUMRYZ was supported by results from REST-ON™?, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcoleps. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS (MWT), clinicians' overall assessment of patients' functioning (CGI-I), and cataplexy attacks, for all three evaluated doses when compared to placebo. With its dose, the single bedtime dose, demonstrated in the REFRESH study to result in clinically meaningful outcomes for both switch and naive oxybate patients. Aankondiging • Jul 31
Avadel Pharmaceuticals plc to Report Q2, 2025 Results on Aug 07, 2025 Avadel Pharmaceuticals plc announced that they will report Q2, 2025 results on Aug 07, 2025 Aankondiging • Jul 14
ASL Strategic Value Fund Files an Exempt Solicitation Statement with Securities and Exchange Commission On 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. Aankondiging • Jul 02
ASL Strategic Value Fund Issues Open Letter to Avadel Shareholders On 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). Aankondiging • Jun 30
Avadel Pharmaceuticals Announces Unanimous Appeals Court Decision Upholding FDA Approval of LUMRYZ in Narcolepsy in Administrative Procedure Act Litigation Avadel 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. Aankondiging • Jun 19
Avadel Pharmaceuticals plc, Annual General Meeting, Jul 29, 2025 Avadel Pharmaceuticals plc, Annual General Meeting, Jul 29, 2025. Location: arthur cox llp, ten earlsfort terrace, dublin 2, d02 t380, Ireland Aankondiging • May 30
Avadel Pharmaceuticals plc to Present New Data on LUMRYZ™? (sodium Oxybate) for Extended-Release Oral Suspension at Sleep 2025 Avadel 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. Aankondiging • May 07
Avadel Pharmaceuticals plc Raises Earnings Guidance for the Full Year 2025 Avadel Pharmaceuticals plc announced that it Raises 2025 full year guidance to $255 - $265 million in net product revenue. Aankondiging • May 06
Avadel Pharmaceuticals Announces Favorable Ruling in Appeal of Delaware Court Injunction Avadel 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. Aankondiging • Apr 30
Avadel Pharmaceuticals plc to Report Q1, 2025 Results on May 07, 2025 Avadel Pharmaceuticals plc announced that they will report Q1, 2025 results on May 07, 2025 Aankondiging • Apr 17
Avadel and nference Announce Publication of Real-World Data on Sodium Oxybate Treatment Patterns in the Journal of Clinical Neuroscience Avadel 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. Aankondiging • Mar 25
Avadel Pharmaceuticals plc Announces Publications in CNS Drugs Supplement Highlighting Key Clinical Issues for People with Narcolepsy and Their Clinicians Avadel 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. Aankondiging • Mar 03
Avadel Pharmaceuticals Reiterates Earnings Guidance for the Year 2025 Avadel 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. Aankondiging • Feb 25
Avadel Pharmaceuticals plc to Report Q4, 2024 Results on Mar 03, 2025 Avadel Pharmaceuticals plc announced that they will report Q4, 2024 results on Mar 03, 2025 Aankondiging • Dec 04
Avadel Pharmaceuticals plc Announces Step Down of Richard Kim as Chief Commercial Officer Effective as of December 31, 2024 On 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 13
Third 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. Aankondiging • Nov 04
Avadel Pharmaceuticals plc to Report Q3, 2024 Results on Nov 12, 2024 Avadel Pharmaceuticals plc announced that they will report Q3, 2024 results on Nov 12, 2024 Aankondiging • Oct 26
Avadel Pharmaceuticals and nference, Inc. Publish Real-World Data on Narcolepsy in Sleep Advances Avadel 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. Aankondiging • Oct 17
Avadel 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 Narcolepsy Avadel 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. Aankondiging • Sep 04
Avadel 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 01
New major risk - Financial position The 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. Aankondiging • Aug 20
Avadel Pharmaceuticals plc Announces Publication in Clinical Therapeutics of Data Highlighting Weight Loss in People with Narcolepsy Treated with LUMRYZ™ (sodium oxybate) Extended-Release Oral Suspension Avadel 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 09
New minor risk - Financial position The 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. Aankondiging • Aug 02
Avadel Pharmaceuticals plc to Report Q2, 2024 Results on Aug 08, 2024 Avadel Pharmaceuticals plc announced that they will report Q2, 2024 results on Aug 08, 2024 Aankondiging • Aug 01
Avadel Pharmaceuticals plc Announces First Patient Dosed in Phase 3 REVITALYZ Trial of LUMRYZ (sodium oxybate) Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia Avadel 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. Aankondiging • Jun 20
Avadel Pharmaceuticals plc, Annual General Meeting, Jul 30, 2024 Avadel Pharmaceuticals plc, Annual General Meeting, Jul 30, 2024. Location: arthur cox llp, ten earlsfort terrace, d02 t380, dublin 2, Ireland Aankondiging • May 24
Avadel Pharmaceuticals plc Appoints Naseem Amin to Its Board of Directors Avadel 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. Aankondiging • May 23
Avadel Pharmaceuticals Shares New LUMRYZ (sodium Oxybate) for Extended-Release Oral Suspension (CIII) Data at Sleep 2024 Avadel 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. Aankondiging • May 10
Avadel 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 Aankondiging • May 09
Avadel 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 Aankondiging • May 03
Avadel Pharmaceuticals plc to Report Q1, 2024 Results on May 08, 2024 Avadel Pharmaceuticals plc announced that they will report Q1, 2024 results on May 08, 2024 Board Change • Apr 18
Insufficient new directors No 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.