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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.
DUBLIN, Ireland, April 10, 2023 - Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced that its management will participate in a fireside chat at the 22nd Annual Needham Healthcare Conference on April 17 at 9:30 a.m. ET. A live webcast will be available on Avadel's Investor Relations website, along with an archived recording for 90 days post-conference. Avadel focuses on innovative solutions for biopharmaceuticals, with its lead candidate LUMRYZ™ designed for treating cataplexy or excessive daytime sleepiness in adults with narcolepsy. This investigational formulation leverages proprietary drug delivery technology. For further details, visit Avadel's website at www.avadel.com.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced the grant of non-statutory options for an aggregate of 46,000 ordinary shares to three new employees, as approved by its Board's Compensation Committee. This initiative, part of Avadel’s 2021 Inducement Plan, aims to incentivize new hires in accordance with Nasdaq Listing Rule 5635(c)(4). The options carry a ten-year term and vest over four years, with 25% vesting annually. Avadel continues to focus on innovative drug solutions, notably its lead candidate, LUMRYZ™, for treating narcolepsy.
Avadel Pharmaceuticals (Nasdaq: AVDL) filed a NDA amendment on March 1 for final FDA approval of LUMRYZ, aimed at treating narcolepsy-related cataplexy and excessive daytime sleepiness. The FDA authorized prior importation of LUMRYZ, expediting its availability post-approval. The company secured $200 million in funding and extended the maturity of $96.2 million in convertible notes to 2027. Preparations for a U.S. launch are on track, supported by a specialty pharmacy network and patient services center. Financial results showed a net loss of $27.5 million for Q4 2022, marking an increase from $22.3 million in Q4 2021.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) has announced a conference call and live webcast on March 30, 2023, at 8:30 a.m. ET, to discuss its financial results for the fourth quarter and full year ending December 31, 2022. The event will offer a corporate update and can be accessed through the investor relations section of Avadel's website. The company’s lead drug candidate, LUMRYZ™, is currently under investigation for treating narcolepsy symptoms. A replay of the event will be available for 90 days post-call.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced the pricing of a public offering consisting of 10,000,001 ordinary shares and 4,705,882 Series B Non-Voting Convertible Preferred Shares, each priced at $8.50. The offering aims to raise approximately $125 million before expenses, with a 30-day option for underwriters to purchase an additional 2,205,882 ADSs. Jefferies LLC is the sole book-running manager for this offering, expected to close on April 3, 2023. The securities are offered under an effective shelf registration statement with the SEC.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced a public offering of its ordinary shares in the form of American Depositary Shares (ADSs) and Series B Non-Voting Convertible Preferred Shares. Each ADS represents one Ordinary Share. The company may grant underwriters a 30-day option for additional ADSs. The offering is conducted by Jefferies LLC as the sole book-running manager, with closing subject to market conditions. The shares are offered under an effective shelf registration with the SEC. Avadel is focused on innovative drug development to improve treatment options, particularly for narcolepsy.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced a royalty agreement with RTW Investments, securing up to $75 million to support the commercialization of LUMRYZ, targeting cataplexy and excessive daytime sleepiness in narcolepsy patients. Additionally, the company extended the maturity of $96.2 million in convertible notes to April 1, 2027. These financings offer enhanced financial flexibility and reflect confidence in LUMRYZ's market potential. Approval pathways for LUMRYZ remain open following a minor amendment submitted to the FDA, building on previous designations and trials demonstrating promising results.
Avadel Pharmaceuticals announces FDA approval for its Pre-Launch Activities Importation Requests (PLAIR) regarding LUMRYZ, a treatment for narcolepsy. This approval permits the company to import LUMRYZ ahead of final approval, significantly shortening the time to market post-approval. The product is designed to treat cataplexy and excessive daytime sleepiness in adults. LUMRYZ has shown promising results in Phase 3 trials, providing hope for enhanced treatment options. The company anticipates that this will allow quicker access to patients once fully approved.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) has granted non-statutory options to a new employee to purchase 15,000 ordinary shares as part of the 2021 Inducement Plan. This decision aligns with Nasdaq Listing Rule 5635(c)(4), providing an incentive for the employee’s acceptance of the role. The options have a ten-year term and will vest over four years, with 25% becoming available annually after the first year. Avadel focuses on innovative medicine solutions, with its lead candidate, LUMRYZ™, targeting narcolepsy treatment using proprietary drug delivery technology.
The global nanobiotechnology market is projected to reach $160.3 billion by 2030, growing at a 5.5% CAGR from an estimated $104.8 billion in 2022. The pharmaceuticals and biotechnology sector is anticipated to hit $110.3 billion by 2030, with a 6.3% CAGR. In the U.S., the market size was $30.6 billion in 2022, while China's market is expected to grow to $27.6 billion by 2030 at 4.8% CAGR. The post-COVID-19 recovery will influence growth, particularly in medical devices with a 3.9% CAGR.
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