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 plc (Nasdaq: AVDL) announced the grant of non-statutory options for 30,000 shares to a new employee as part of its 2021 Inducement Plan. The options will vest over four years, with 25% vesting after one year and the remainder vesting monthly thereafter, contingent on the employee's continued service. This grant complies with Nasdaq Listing Rule 5635(c)(4). Avadel is focused on innovative medication development, including its lead candidate LUMRYZ™, an investigational treatment for narcolepsy. For further information, visit www.avadel.com.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced its participation in two upcoming investor conferences. Management will engage in a fireside chat at the Piper Sandler 34th Annual Healthcare Conference on November 29 at 3:30 p.m. ET, and at the Evercore ISI HealthCONx Conference on December 1 at 2:40 PM ET. Live webcasts and archived recordings will be accessible on Avadel’s Investor Relations website for 90 days post-conference. Avadel focuses on innovative treatments like LUMRYZ™, aimed at addressing narcolepsy symptoms.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced that the U.S. District Court for Delaware has ordered Jazz Pharmaceuticals to delist U.S. Patent No. 8731963, known as the REMS Patent, from the FDA's Orange Book. This ruling may accelerate FDA approval for LUMRYZ™, an investigational sodium oxybate formulation for treating narcolepsy symptoms. LUMRYZ already received tentative FDA approval in July 2022, pending the REMS Patent's status. Avadel aims to collaborate with the FDA to finalize approval and make LUMRYZ available to patients with narcolepsy.
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.