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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 plc (Nasdaq: AVDL) will participate in a fireside chat at the Jefferies London Healthcare Conference on November 17, 2022, at 2:40 p.m. GMT / 9:40 a.m. ET. A live webcast and an archived recording will be available on their Investor Relations website for 90 days following the event. The company focuses on innovative biopharmaceutical solutions, with its lead candidate, LUMRYZ™, aimed at treating narcolepsy. Further details can be found on Avadel's website.
Avadel Pharmaceuticals (AVDL) announced the tentative approval of its narcolepsy treatment, LUMRYZ, on July 18, confirming its safety and efficacy. Final approval is expected by June 2023, with a commercial launch planned by Q3 2023. Recent data shows that 94% of switch patients prefer LUMRYZ's once-at-bedtime regimen over traditional options. Financial results for Q3 2022 revealed a net loss of $20.1 million, a decrease from $22.0 million year-over-year, with cash reserves of $106.5 million. The company is actively preparing for the product launch post-approval.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced the granting of non-statutory options to two new employees, totaling 130,000 ordinary shares, as part of its 2021 Inducement Plan. These options have a ten-year term and vest over four years, with 25% vesting after one year and the remainder in monthly installments. This move is in compliance with Nasdaq Listing Rule 5635(c)(4) and aims to incentivize employee retention and commitment. Avadel focuses on innovative medication solutions, notably its lead candidate LUMRYZ™, for treating narcolepsy.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) will host a conference call on November 9, 2022, at 8:00 a.m. ET to discuss its third-quarter financial results for the period ending September 30, 2022. Investors can dial in at (800) 715-9871 or (646) 307-1963 and will need the conference ID 6188743 to join. The call will also be accessible via a live audio webcast on the company's investor relations website. Avadel focuses on innovative drug delivery solutions, notably its lead candidate LUMRYZ, intended for treating narcolepsy.
Avadel Pharmaceuticals (Nasdaq: AVDL) unveiled new data at the ANA annual meeting regarding narcolepsy patients, revealing a higher occurrence of mood, sleep, and pain disorders among those affected. The analysis, involving over 2,000 patients, highlighted significant comorbidities such as restless leg syndrome and chronic pain. Furthermore, positive results from the Phase 3 REST-ON trial for LUMRYZ, a once-nightly sodium oxybate treatment, were reaffirmed, showing patient preference for this regimen. With FDA approval pending, Avadel aims to reshape narcolepsy treatment.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced that its management will participate in a fireside chat at the Ladenburg Thalmann Healthcare Conference on September 29, 2022, at 12:30 p.m. E.T. A live webcast and an archived recording will be available on Avadel’s Investor Relations website for 90 days post-conference.
The company focuses on transforming medicines, with its lead drug candidate, LUMRYZ™, a sodium oxybate formulation designed for narcolepsy treatment.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) will participate in a fireside chat at the H.C. Wainwright Global Investment Conference on September 14 at 11:30 a.m. E.T. The discussion will focus on the company's innovative approaches to medicine, notably their lead drug candidate, LUMRYZ™, which is designed for the treatment of cataplexy and excessive daytime sleepiness in adults with narcolepsy. Investors can access a live webcast and archived recording on the Investor Relations website.
Avadel Pharmaceuticals (AVDL) announced tentative FDA approval for LUMRYZ (sodium oxybate) on July 18, 2022, signaling progress towards final approval, expected by June 2023. The company is pursuing legal actions to expedite approval, including a lawsuit against the FDA and delisting a REMS patent. Financial results for Q2 revealed a net loss of $63.4 million, an increase from $19.6 million a year prior. Cash reserves stand at $104.1 million, with plans to reduce cash operating expenses to $12-$14 million per quarter.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced a conference call on August 9, 2022, at 8:00 a.m. ET to discuss its corporate update and financial results for Q2 2022, which ended on June 30. Investors can join the call by dialing (833) 630-0586 (U.S.) or (412) 317-1827 (International). A live audio webcast will also be available on the company's investor relations website, with a replay archived for 90 days. Avadel focuses on innovative drug solutions, with LUMRYZ, an investigational sodium oxybate formulation for narcolepsy, as its lead candidate.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced that the FDA has granted tentative approval for LUMRYZ (FT218), a once-at-bedtime formulation of sodium oxybate for treating excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy. This approval confirms LUMRYZ’s clinical efficacy and safety. The company estimates a total patient population exceeding 30,000 and a potential market opportunity of over $3 billion annually. Avadel is pursuing strategies to accelerate final approval, which is expected by June 2023.
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