Avadel Pharmaceuticals plc - $AVDL STOCK NEWS

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.

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.

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.

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.

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.

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.

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.

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.

Avadel Pharmaceuticals plc (AVDL) schedules conference call to discuss financial results for Q4 and full year 2023, along with a corporate update.