Welcome to our dedicated page for Avadel Pharmaceu news (Ticker: AVDL), a resource for investors and traders seeking the latest updates and insights on Avadel Pharmaceu stock.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company whose news flow centers on its sleep medicine franchise, led by LUMRYZ, and on significant corporate transactions. Company announcements repeatedly describe Avadel as focused on transforming medicines to transform lives, with a commercial emphasis on LUMRYZ, an FDA-approved, once-at-bedtime extended-release sodium oxybate for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years and older with narcolepsy.
News updates for AVDL commonly include clinical and regulatory milestones for LUMRYZ. Examples from recent press releases include completion of enrollment in REVITALYZ, a Phase 3 trial evaluating once-at-bedtime LUMRYZ as a potential treatment for idiopathic hypersomnia, and presentation of real-world REFRESH study data in narcolepsy. These items provide insight into Avadel’s efforts to expand the clinical evidence base and explore additional indications for its lead product, while clearly noting that LUMRYZ is only approved for narcolepsy.
Investors following AVDL news will also see frequent coverage of transaction-related developments. Avadel has announced a definitive agreement under which Alkermes plc will acquire the company via an Irish High Court–sanctioned scheme of arrangement, subsequent amendments to increase the offer, and shareholder approvals of the scheme. Additional news has covered an unsolicited proposal from H. Lundbeck A/S, the Avadel board’s evaluation of that proposal, and the board’s conclusions under the Irish Takeover Rules and the Alkermes Transaction Agreement.
Other recurring news themes include licensing and legal developments, such as Avadel’s exclusive global license for valiloxybate from XWPharma and a global settlement and license agreement with Jazz Pharmaceuticals relating to LUMRYZ and Jazz’s oxybate products. Together, these updates give readers a view into AVDL’s clinical pipeline, commercial performance, strategic partnerships and the progress of the Alkermes acquisition. For ongoing context on AVDL stock, this news page aggregates these company-issued announcements and related regulatory disclosures.
Avadel Pharmaceuticals (Nasdaq: AVDL) has announced its upcoming participation in the 24th Annual Needham Healthcare Conference. The company's management team will engage in a fireside chat scheduled for Tuesday, April 8 at 1:30 p.m. ET.
Investors and interested parties can access a live webcast of the presentation through Avadel's Investor Relations website at investors.avadel.com. The recorded session will remain available on the website for 90 days following the conference.
Avadel Pharmaceuticals (Nasdaq: AVDL) has announced the publication of six manuscripts in a CNS Drugs supplement titled 'A New Dawn in the Management of Narcolepsy'. The publications focus on clinical management, shared decision-making, and goal setting for narcolepsy patients and their healthcare providers.
Dr. Michael J. Thorpy, Director at the Sleep-Wake Disorders Center at Montefiore Medical Center and a Phase 3 REST-ON trial investigator for LUMRYZ™, served as guest editor. The supplement emphasizes sodium oxybate therapy and includes new analyses of efficacy onset and practical considerations for once-nightly treatment.
Dr. Jennifer Gudeman, SVP of Medical and Clinical Affairs at Avadel, highlighted that while sodium oxybate has been FDA-approved for over 20 years, it remains underutilized due to burdensome first-generation dosing. The publications detail LUMRYZ's data, addressing nighttime sleep disturbances and treatment expectations, noting that patients may experience initial effects within 1-2 weeks, with increasing improvements from week three onward.
Avadel Pharmaceuticals (Nasdaq: AVDL) has announced its upcoming participation in two major investor conferences in March 2025. The company will be featured in:
- A fireside chat at the Leerink Global Biopharma Conference on Wednesday, March 12 at 9:20 a.m. ET
- A fireside chat at the UBS Virtual CNS Day on Monday, March 17 at 8:30 a.m. ET
Both events will be accessible through live webcasts on Avadel's Investor Relations website (investors.avadel.com), with recordings remaining available for 90 days after each conference.
Avadel Pharmaceuticals (NASDAQ: AVDL) reported strong Q4 2024 financial results, with LUMRYZ sales reaching $50.4 million, a 158% year-over-year increase. Full-year LUMRYZ revenue totaled $169.1 million.
The company reiterated its 2025 guidance, projecting net product revenue of $240-260 million and cash flow of $20-40 million. Patient count is expected to grow from 2,500 (as of December 2024) to 3,300-3,500 by end-2025.
Key Q4 metrics include: 74% of patients on therapy were reimbursed, R&D expenses were $4.3 million, and SG&A expenses reached $44.6 million. The company reported a reduced net loss of $5.0 million ($0.05 per share) compared to $28.8 million ($0.32 per share) in Q4 2023.
Notable developments include FDA approval for LUMRYZ in pediatric narcolepsy patients aged 7+ and ongoing enrollment in the Phase 3 REVITALYZ study for Idiopathic Hypersomnia.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced it will host a conference call and live webcast on March 3, 2025, at 8:30 a.m. ET to discuss its fourth quarter and full year 2024 financial results, along with providing a corporate update. The webcast will be accessible through the company's investor relations website section, and a replay will be available for 90 days afterward. Interested participants are advised to register for the conference call at least 10 minutes before it begins.
Avadel Pharmaceuticals (Nasdaq: AVDL) has appointed Kevin Springman as Vice President of Sales. Springman brings over 25 years of sales, marketing, and market access leadership experience, including 22 years at AstraZeneca and leadership roles at Sobi and Albireo Pharma.
The appointment comes as Avadel continues to build momentum behind LUMRYZ, its FDA-approved treatment for narcolepsy. The company is implementing a comprehensive commercial strategy to increase demand for LUMRYZ, aiming to tap into its billion-dollar market potential. Additionally, Avadel is progressing with a Phase 3 trial in idiopathic hypersomnia (IH), positioning itself as a leader in sleep disorder treatments.
The company is also actively searching for a new commercial organization leader as part of its executive team strengthening efforts.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced that its Compensation Committee has approved inducement awards for five new employees. The awards consist of non-statutory options to purchase 173,000 ordinary shares under the company's 2021 Inducement Plan, granted in accordance with Nasdaq Listing Rule 5635(c)(4).
The options feature a ten-year term and a four-year vesting schedule, with 25% vesting on the first anniversary of each employee's start date and additional 25% portions vesting on subsequent anniversaries through the fourth year. These grants are governed by Avadel's 2021 Inducement Plan, which was approved by the Board of Directors in November 2021.
ASL Strategic Value Fund, a long-term investor in Avadel Pharmaceuticals (AVDL), has sent a letter to the company's Board expressing concerns over management's performance and calling for immediate action to maximize shareholder value. The letter criticizes the management's handling of Lumryz launch and poor communication, highlighting significant stock underperformance with YTD -21.69% vs NASDAQ's -0.74% in 2025.
The fund emphasizes two key assets: Lumryz, a once-nightly sodium oxybate formulation, and pending lawsuits against Jazz Pharmaceuticals. The main lawsuit, scheduled for November 2025, claims $1.5 billion in damages (potentially reaching $4.5 billion after trebling) or approximately $45 per share. Management projects peak Lumryz sales of $1 billion in narcolepsy, potentially generating $6 per share in earnings, with additional upside from Idiopathic Hypersomnia indication pending Phase III trial completion.
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.
FAQ
What is the current stock price of Avadel Pharmaceu (AVDL)?
What is the market cap of Avadel Pharmaceu (AVDL)?
