![]() ![]() ![]() Lumryz is an investigational once-at-bedtime, extended-release formulation of sodium oxybate that utilizes proprietary Avadel's drug-delivery technology for the treatment of cataplexy or EDS in adults with narcolepsy. Introducing Lumryz: An Investigational Once-at-Bedtime Treatment of Cataplexy and EDS in Adults with Narcolepsy Additionally, the company held convertible debt of $26.4 million and $117.4 million, with the former maturing in February 2023 and the latter in October 2023. As of September 30, 2022, Avadel's total cash, cash equivalents, and marketable securities amounted to $106.5 million. Avadel reported a net loss of $20.1 million for the quarter, equivalent to ($0.33) per diluted share, compared to a net loss of $22.0 million or ($0.38) per diluted share in 2021. However, these savings were partially offset by higher legal expenses. Similarly, Avadel's selling, general, and administrative expenses decreased to $14.1 million during the quarter due to reduced costs in areas such as marketing, compensation, medical affairs, and consulting fees. This decrease was due to reduced costs associated with the production of Lumryz, as well as lower compensation expenses. In the quarter ending on September 30, 2022, the company's research and development expenses decreased to $2.9 million when compared to the same period in 2021. To begin, let us examine the most recent financial report from Avadel. However, the tentative approval is subject to change based on any new information the FDA may receive, and the drug cannot be marketed until final approval is granted. The decision on final FDA approval could happen on or before the expiration of the REMS Patent on June 17, 2023. Once Jazz files the request for delisting, Avadel will seek final FDA approval for Lumryz. On February 24, 2023, the court denied Jazz's appeal and mandated them to delist the REMS Patent within 14 days. Court of Appeals for the Federal Circuit. The Delaware Court ordered Jazz Pharmaceuticals to delist the REMS Patent on November 18, 2022, but Jazz appealed the decision to the U.S. However, the final FDA approval is pending due to the REMS Patent listed in the FDA's Orange Book. Food and Drug Administration for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. On July 18, 2022, Lumryz received tentative approval from the U.S. Lumryz is an investigational extended-release formulation of sodium oxybate used to treat excessive daytime sleepiness and cataplexy (sudden muscle weakness while awake) in adults with narcolepsy. Yanyong/iStock via Getty Images IntroductionĪvadel Pharmaceuticals ( NASDAQ: AVDL) is a pharmaceutical company with a lead product candidate called Lumryz, also known as FT218. ![]()
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