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Avadel Pharmaceuticals plc - $AVDL STOCK NEWS

Welcome to our dedicated page for Avadel Pharmaceuticals plc news (Ticker: $AVDL), a resource for investors and traders seeking the latest updates and insights on Avadel Pharmaceuticals plc stock.

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.

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Avadel Pharmaceuticals (Nasdaq: AVDL) has announced that its management will participate in two upcoming investor conferences. The company will join the Jefferies Global Healthcare Conference for a fireside chat on June 6 at 10:30 a.m. ET, and the Goldman Sachs 45th Annual Global Healthcare Conference for a fireside chat on June 12 at 3:20 p.m. ET. These events will be live-streamed and archived on Avadel's Investor Relations website for 90 days post-conference.

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Avadel Pharmaceuticals (Nasdaq: AVDL) will present 11 posters and one oral presentation on LUMRYZ, an extended-release oral suspension for narcolepsy, at SLEEP 2024 from June 1-5 in Houston. LUMRYZ, FDA-approved in 2023, is the first once-nightly sodium oxybate for cataplexy and excessive daytime sleepiness (EDS). Key findings from the RESTORE study indicate 94% of patients prefer LUMRYZ over twice-nightly oxybate, with 91% reporting improved sleep quality and 89% likely to recommend it. Presentations will cover patient satisfaction, symptom control, dosing adherence, and demographic comparisons. The drug's boxed warning includes CNS depression and abuse potential. Common side effects are nausea, dizziness, enuresis, headache, and vomiting. The new data underscores LUMRYZ's effectiveness and patient preference in narcolepsy treatment.

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Avadel Pharmaceuticals announced the appointment of Naseem Amin, M.D. to its board of directors, effective May 17, 2024. Dr. Amin, an executive with 30 years of global industry experience, currently serves as CEO of Orphalan SA. His background includes roles at Arix Bioscience, Advent Life Sciences, Smith and Nephew, Biogen Idec, Genzyme , and Baxter Healthcare. Dr. Amin joins Avadel as the company focuses on the commercial launch of LUMRYZ, a treatment for narcolepsy, and its potential expansion into pediatric and idiopathic hypersomnia markets.

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Avadel Pharmaceuticals reported strong financial results for the first quarter of 2024, generating $27.2 million in net revenue from LUMRYZ sales. The company enrolled over 2,800 patients in RYZUP patient support services, with more than 1,700 patients initiating therapy. Avadel is seeking to expand LUMRYZ usage through a sNDA for pediatric narcolepsy and plans to start a Phase 3 trial for idiopathic hypersomnia. Despite a net loss of $27.3 million, Avadel holds $88.8 million in cash and marketable securities as of March 31, 2024.

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Avadel Pharmaceuticals plc will host a conference call and live webcast on May 8, 2024, to provide a corporate update and discuss the financial results for the first quarter of 2024. Investors can access the call through dial-in numbers or the company's website.

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Avadel Pharmaceuticals plc (AVDL) to participate in the 23rd Annual Needham Healthcare Conference with a fireside chat on April 8th. The event will be live webcasted and archived for 90 days.
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Avadel Pharmaceuticals plc (AVDL) will participate in upcoming investor conferences to discuss their biopharmaceutical endeavors. The company aims to transform medicines and lives through its innovative approach.
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Avadel Pharmaceuticals plc responds to a jury ruling from the United States District Court for the District of Delaware in a patent suit brought by Jazz Pharmaceuticals Inc. regarding LUMRYZ™. The jury ruled in favor of Avadel on one patent but against on another. Avadel plans to vigorously defend its position, including a possible appeal, to overturn the unfavorable ruling. The company remains optimistic about the commercial launch and transformative potential of LUMRYZ™ for narcolepsy patients.
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Avadel Pharmaceuticals plc (AVDL) reported $19.5 million in Q4 and $28.0 million in full-year 2023 net revenue from LUMRYZ sales. Over 2,200 patients enrolled in RYZUPTM with 1,200 starting therapy. Payer coverage exceeds 80% with new listings like United Healthcare and Anthem. FDA set a September 7, 2024, target action date for LUMRYZ's sNDA in pediatric narcolepsy. Financially, R&D expenses decreased due to lower pre-commercial costs, while SG&A expenses rose due to LUMRYZ launch and increased headcount. Net losses slightly increased to $28.8 million for Q4 and $160.3 million for the year. Cash, cash equivalents, and marketable securities stood at $105.1 million as of December 31, 2023.
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Avadel Pharmaceuticals plc (AVDL) schedules conference call to discuss financial results for Q4 and full year 2023, along with a corporate update.
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FAQ

What is Avadel Pharmaceuticals plc?

Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a specialty pharmaceutical company focused on developing differentiated pharmaceutical products for urology, CNS/sleep, and hospital markets.

What is LUMRYZ?

LUMRYZ is an extended-release formulation of sodium oxybate, approved by the FDA for treating cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. It is taken once at bedtime.

Where is Avadel Pharmaceuticals headquartered?

Avadel Pharmaceuticals is headquartered in Dublin, Ireland, with additional operations in St. Louis, Missouri, and Lyon, France.

What recent financial results did Avadel report?

For the third quarter ended September 30, 2023, Avadel reported $7.0 million in net product revenue from LUMRYZ sales and a net loss of $36.3 million.

What distinguishes LUMRYZ from other treatments?

LUMRYZ is the first and only once-at-bedtime oxybate treatment for narcolepsy, offering a more convenient dosing regimen compared to twice-nightly oxybate products.

What are the most common side effects of LUMRYZ?

The most common side effects include nausea, dizziness, bedwetting, headache, and vomiting.

What is the significance of LUMRYZ's Orphan Drug Exclusivity?

The FDA granted LUMRYZ seven years of Orphan Drug Exclusivity due to its significant contribution to patient care, providing a once-nightly dosing alternative to existing treatments.

How did the narcolepsy community respond to the launch of LUMRYZ?

The launch received overwhelmingly positive feedback, with early patient demand and significant support from healthcare providers and payers.

What other areas does Avadel Pharmaceuticals focus on?

In addition to narcolepsy, Avadel focuses on developing treatments for urology and hospital markets.

What are Avadel’s future plans for LUMRYZ?

Avadel plans to expand LUMRYZ's indication to pediatric patients and continue its Phase 3 trials for idiopathic hypersomnia.

Avadel Pharmaceuticals plc

Nasdaq:AVDL

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Medicinal and Botanical Manufacturing
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