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Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a specialty pharmaceutical company headquartered in Dublin, Ireland, with operations in St. Louis, Missouri, and Lyon, France. The company focuses on developing, identifying, and commercializing differentiated pharmaceutical products designed to be safe, effective, and easy to administer, thereby improving patient adherence and outcomes. Avadel's products primarily target the urology, central nervous system (CNS) / sleep, and hospital markets.
One of Avadel's flagship products is LUMRYZ™, an extended-release formulation of sodium oxybate, approved by the U.S. Food & Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. LUMRYZ is notable for its once-at-bedtime dosing, which eliminates the need for a middle-of-the-night dose, making it more convenient for patients.
The FDA granted LUMRYZ seven years of Orphan Drug Exclusivity, recognizing it as a major contribution to patient care over existing therapies. The approval was supported by results from the REST-ON trial, a Phase 3 study that demonstrated significant improvements in EDS, the Clinician Global Impression of Improvement (CGI-I), and reduced the frequency of cataplexy attacks.
Avadel recently announced its financial results for the third quarter ended September 30, 2023, reporting $7.0 million in net product revenue from LUMRYZ sales. The company has seen robust demand and positive feedback from the narcolepsy community, healthcare providers, and payers. Notably, CVS Health has moved LUMRYZ to preferred status starting January 1, 2024. Avadel also filed a supplemental NDA to extend LUMRYZ's indication to pediatric patients with narcolepsy, further expanding its market reach.
Financially, Avadel reported a net loss of $36.3 million for the quarter, driven by higher selling, general, and administrative expenses related to the LUMRYZ launch. Despite these challenges, the company maintains a strong cash position of $153.2 million as of September 30, 2023.
Looking ahead, Avadel plans to issue its Annual Report on Form 10-K for the year ended December 31, 2023, on February 29, 2024. The company continues to focus on expanding its product pipeline, including initiating a Phase 3 trial for idiopathic hypersomnia and optimizing commercial execution for LUMRYZ.
Avadel Pharmaceuticals (NASDAQ: AVDL) has appointed Sev Melkonian as Vice President of Patient Services, Distribution, and Reimbursement. Melkonian brings over 20 years of healthcare operations and patient services leadership experience, most recently serving at Takeda Pharmaceuticals where he led Patient Access Partner Operations.
The appointment comes as Avadel continues its search for a new Chief Commercial Officer while focusing on establishing LUMRYZ as the preferred oxybate treatment in the narcolepsy community. Melkonian's expertise includes building healthcare operations, managing patient support service teams, and navigating rare disease drug commercialization.
Melkonian's educational background includes an MBA from Northeastern University, an MHA from Suffolk University, and a BS in Pharmacy from the Massachusetts College of Pharmacy and Health Sciences. His previous experience also includes leadership roles at CVS Health's Pharmaceutical Purchasing Organization.
Avadel Pharmaceuticals (NASDAQ: AVDL) reported strong preliminary Q4 2024 results for LUMRYZ, their narcolepsy treatment. Q4 net revenue reached approximately $50.0 million, representing a 150% increase from Q4 2023's $19.5 million. Full-year 2024 revenue was approximately $169.0 million, up from $28.0 million in 2023.
The company achieved 2,500 patients on LUMRYZ by December 31, 2024, a 275% increase from 900 patients in 2023, with 600 new patients in Q4. Patient composition included 38% switching from first-generation oxybates, 34% new to oxybate, and 28% previously discontinued oxybate users. About 74% of patients were reimbursed.
For 2025, Avadel projects net product revenue of $240-260 million, a 50% year-over-year growth at midpoint, with expected cash flow of $20-40 million. The company aims to have 3,300-3,500 total patients on therapy by end-2025.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced that its Board's Compensation Committee has approved inducement awards for twelve new employees. The awards consist of non-statutory options to purchase 131,700 ordinary shares under the company's 2021 Inducement Plan. These options come with a ten-year term and follow a four-year vesting schedule, with 25% vesting on the first anniversary of each employee's start date and subsequent 25% portions vesting on the second, third, and fourth anniversaries. The grants were made in accordance with Nasdaq Listing Rule 5635(c)(4) as inducement material for employment acceptance.
Avadel Pharmaceuticals (Nasdaq: AVDL) has announced it will host a conference call and live webcast on January 8, 2025, at 4:30 p.m. ET to provide a corporate update and discuss preliminary unaudited financial results for Q4 and full-year 2024. The webcast will be accessible through the company's investor relations website section at www.avadel.com, where it will remain archived for 90 days after the event. Participants are encouraged to register for the conference call at least 10 minutes before the start time.
Avadel Pharmaceuticals (Nasdaq: AVDL) published findings in Brain Sciences revealing significant challenges faced by narcolepsy patients using twice-nightly sodium oxybate therapy. The study combined social media analysis and survey results from 87 U.S. adults.
Key findings showed that 75.3% of respondents reported accidentally missing their second dose, with 37% missing it weekly or more often. Nearly three-fourths reported improper timing of their second dose, with 58.8% taking it too late and 21.2% too early. Notably, 31.8% experienced injuries after waking for their second dose.
The study highlighted that inconsistent adherence leads to poor sleep quality, excessive daytime sleepiness, and decreased productivity. 75.9% of respondents agreed that a once-nightly dose would be safer than twice-nightly formulations.
Avadel Pharmaceuticals (Nasdaq: AVDL) has announced its upcoming participation in the Jefferies London Healthcare Conference. The company's management will engage in a fireside chat on Wednesday, November 20 at 7:30 a.m. GMT / 2:30 a.m. ET. Interested parties can access a live webcast of the discussion through Avadel's Investor Relations website at investors.avadel.com, where the recording will remain available for 90 days after the conference.
Avadel Pharmaceuticals reported strong Q3 2024 results with $50.0 million in net revenue from LUMRYZ sales. The company reached 2,300 patients on LUMRYZ by September 30th, adding 700 new patients in Q3. Key developments include FDA approval for LUMRYZ in patients 7 years and older with narcolepsy, granted Orphan Drug Exclusivity through October 2031. The company reported a minimal operating loss of $0.3 million and a net loss of $2.6 million ($0.03 per share). Cash position stood at $65.8 million as of September 30, 2024.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced it will host a conference call and live webcast on November 12, 2024, at 8:30 a.m. ET to discuss its third quarter 2024 financial results and provide a corporate update. The conference call can be accessed by dialing (800) 579-2543 with conference ID AVADEL. A live webcast will be available on the company's investor relations website, and a replay will be archived for 90 days.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced a favorable U.S. District Court ruling upholding the FDA's approval of LUMRYZ, the first once-at-bedtime oxybate treatment for narcolepsy. The Court ruled against Jazz Pharmaceuticals' challenge under the Administrative Procedure Act, confirming LUMRYZ's clinical superiority to Jazz's twice-nightly oxybate products. The decision maintains LUMRYZ's Orphan Drug Exclusivity granted in May 2023 and validates its unique dosing schedule as a significant advancement in patient care.
Avadel Pharmaceuticals (AVDL) and nference published real-world data in Sleep Advances analyzing demographic characteristics and comorbidities in narcolepsy patients. The study, based on electronic health data from over 2,000 narcolepsy patients and 2,000 matched controls through Mayo Clinic Platform, revealed that people with narcolepsy were more likely to have psychiatric, sleep, and pain disorders. Unlike previous claims-based studies, cardiovascular disease was not among the top 20 comorbidities. This marks the first real-world study in narcolepsy using aggregate electronic health record data.
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