Latest news with #AvadelPharmaceuticals
Reuters
2 days ago
- Business
- Reuters
ASL pushes for board shakeup at Avadel over handling of sleep drug rollout
June 30 (Reuters) - ASL Strategic Value Fund on Monday urged shareholders of Avadel Pharmaceuticals (AVDL.O), opens new tab to replace its board, citing mismanagement in the rollout of the drugmaker's flagship sleep disorder drug Lumryz since its launch two years ago. The hedge fund said Avadel was unable to convert patients to its drug Lumryz from its rivals, despite the treatment being what it called "best-in-class", leaving hundreds of millions in potential revenue unrealized. Lumryz, which competes with Jazz Pharmaceuticals' (JAZZ.O), opens new tab treatments, is approved in the United States to treat certain symptoms of narcolepsy by using a central nervous system depressant drug called sodium oxybate. ASL said "constant mis-steps" with the launch of Lumryz and miscommunication over the last several years with investors had destroyed significant shareholder value along with the management's credibility. ASL said Avadel should have converted 40% to 50% of sodium oxybate users within two years of launching Lumryz, an opportunity that could have generated an additional $600 million to $800 million in revenue. "The status quo at Avadel is unacceptable," ASL told shareholders in its letter. The election for the directors will be held at the company's annual meeting on July 29. ASL also asked Avadel to hire an investment bank to monetize the value in Lumryz, adding that the drug could bring $500 million to $1 billion in revenue if approved for idiopathic hypersomnia, a condition that causes excessive sleepiness. The fund holds shares worth about $15 million in Avadel according to a Wall Street Journal report on Sunday. Avadel told Reuters on Monday that its board has "consistently engaged with its largest shareholders and proactively sought their perspectives". The company said it remains focused on unlocking the full value of Lumryz in narcolepsy and in future indications. Separately, Avadel said the U.S. Court of Appeals for the District of Columbia Circuit gave a favorable, opens new tab ruling in a suit brought by Jazz regarding the FDA's approval of Lumryz. The ruling affirms FDA's decision to state that Lumryz's once-nightly dosing is clinically superior to other similar treatments.
Reuters
2 days ago
- Business
- Reuters
ASL Strategic Value Fund targets Avadel board over Lumryz drug mismanagement, WSJ reports
June 29 (Reuters) - ASL Strategic Value Fund plans to push shareholders of drugmaker Avadel Pharmaceuticals (AVDL.O), opens new tab to vote to remove the company's board, citing mismanagement in the launch of its flagship sleep disorder drug, the Wall Street Journal reported on Sunday. The fund, which holds shares worth about $15 million in Avadel, plans to publish an open letter arguing that the mismanagement in the launch of the drug called Lumryz resulted in the company missing out on hundreds of millions of dollars in revenue, the report said, citing a copy of the letter. The investment firm also reiterated a call to the Ireland-based drugmaker to hire an investment bank and explore alternatives including a sale, the report added. Reuters could not independently establish the veracity of the report. Avadel and ASL did not immediately respond to Reuters' requests for comment. Last year, the U.S. Food and Drug Administration approved Lumryz for children aged 7 years and older who presented with sudden muscle weakness, called cataplexy, or excessive daytime sleepiness, both symptoms of the sleep disorder called narcolepsy. Narcolepsy is a chronic neurological disorder that impacts the brain's ability to regulate sleep and wake cycles, with 70% of patients also experiencing cataplexy.
Wall Street Journal
2 days ago
- Business
- Wall Street Journal
Avadel Shareholder Seeks Ousting Drugmaker's Entire Board
An investor in the narcolepsy drugmaker Avadel Pharmaceuticals AVDL -0.97%decrease; red down pointing triangle plans to call for shareholders to vote out the company's entire board of directors, ratcheting up pressure on management in a tough environment for biopharmaceutical firms. ASL Strategic Value Fund plans to publish an open letter arguing that Avadel has mismanaged the launch of its main treatment, causing the company to miss out on hundreds of millions of dollars in revenue, according to a copy of the letter viewed by The Wall Street Journal.
Yahoo
31-05-2025
- Business
- Yahoo
Avadel Pharmaceuticals plc (AVDL) Showcases LUMRYZ Success with 14 Abstracts, 4 Oral Presentations at SLEEP 2025
Avadel Pharmaceuticals plc (NASDAQ:AVDL) announced it will present 14 new abstracts, including four oral presentations, at SLEEP 2025, highlighting significant advances for LUMRYZ, its once-at-bedtime sodium oxybate treatment for narcolepsy. Interim results from the real-world REFRESH study showed that patients switching from twice-nightly oxybate to LUMRYZ experienced clinically meaningful improvements in excessive daytime sleepiness (EDS), with many achieving normal Epworth Sleepiness Scale (ESS) scores. A scientist in a labcoat examining a vial of experimental biopharmaceuticals. Additional analyses from the pivotal Phase 3 REST-ON trial revealed that even those with the most severe baseline sleepiness saw their ESS scores normalize after 13 weeks on LUMRYZ, and the therapy did not worsen sleep apnea. Further data demonstrated a reduction in distressing hallucinations and improvement in sleep-related eating disorder (SRED) symptoms after switching to LUMRYZ. Long-term tolerability was underscored, with only 4% discontinuing due to side effects. Avadel Pharmaceuticals plc (NASDAQ:AVDL) emphasized that LUMRYZ, FDA-approved for adults and children aged 7 and older, offers a major benefit over traditional oxybate by eliminating the need for middle-of-the-night dosing, supporting better sleep continuity and patient care. With these compelling results, Avadel Pharmaceuticals plc (NASDAQ:AVDL) continues to solidify its leadership in innovative narcolepsy treatments. While we acknowledge the potential of AVDL to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than AVDL and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Sign in to access your portfolio
