Avadel wins appeal to expand LUMRYZ trials beyond narcolepsy

DUBLIN - Avadel Pharmaceuticals plc (NASDAQ:AVDL), a biopharmaceutical company with impressive revenue growth of over 500% in the last twelve months and a market capitalization of $874 million, has received a favorable ruling from the United States Court of Appeals for the Federal Circuit, enabling the company to pursue FDA approval for its drug LUMRYZ™ in treating conditions beyond narcolepsy. This decision overturns a previous injunction by the U.S. District Court for the District of Delaware.

The Federal Circuit vacated parts of the injunction that barred Avadel from applying for FDA approval for LUMRYZ for any indications other than narcolepsy. It also lifted restrictions that prevented the company from offering open-label extensions to trial participants and initiating new clinical trials with LUMRYZ for additional indications.

Greg Divis, CEO of Avadel, expressed satisfaction with the decision, stating it clears the path for the company to initiate new clinical trials and seek FDA approval for LUMRYZ in the treatment of Idiopathic Hypersomnia (IH) and other conditions. Avadel remains focused on demonstrating the clinical value of their extended-release, once-at-bedtime medication.

The company’s REVITALYZ™ trial, a Phase 3 study evaluating the efficacy and safety of LUMRYZ in IH, is on track, with patient enrollment expected to complete by the end of 2025. The study will include about 150 adults diagnosed with IH, including those switching from immediate-release oxybates and those not currently on oxybates. According to InvestingPro data, Avadel maintains strong financial health with a current ratio of 2.75, indicating robust liquidity to support its clinical development programs.

LUMRYZ, an extended-release sodium oxybate medication, was first approved by the FDA in May 2023 as a once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. In October 2024, it was also approved for the same indications in pediatric patients aged 7 and older.

The FDA granted LUMRYZ seven years of Orphan Drug Exclusivity for its treatment of narcolepsy in both adults and pediatric patients, recognizing its clinical superiority over existing twice-nightly oxybate treatments due to its once-nightly dosing regimen.

Avadel, a biopharmaceutical company, is committed to transforming medicines to improve patients’ lives. The recent court ruling supports the company’s strategy to expand the potential uses of LUMRYZ. With an industry-leading gross profit margin of 91% and strong analyst support, InvestingPro analysis suggests the stock is currently undervalued, with analysts setting price targets up to $22 per share. The information in this article is based on a press release statement from Avadel Pharmaceuticals plc. For comprehensive analysis and additional insights, including 8 more ProTips about AVDL, visit InvestingPro’s detailed research report.

In other recent news, Avadel Pharmaceuticals has reported steady demand for its narcolepsy medication, LUMRYZ™, with patient metrics for the first quarter of 2025 showing improvement over the last quarter of 2024. The company confirmed its fourth-quarter 2024 revenue of $50 million, meeting prior expectations, and reaffirmed its 2025 sales guidance of $240-260 million. Avadel is currently involved in four patent infringement lawsuits against Jazz Pharmaceuticals, asserting that Jazz’s Xywav product infringes on multiple Avadel patents. Analysts from H.C. Wainwright and Oppenheimer have maintained their positive outlooks on Avadel, with H.C. Wainwright reiterating a Buy rating with a $21 target and Oppenheimer maintaining an Outperform rating with a $22 target. Both firms highlighted Avadel’s strategic initiatives, such as expanding its sales force and marketing efforts, as factors that could drive future revenue growth. The company has also announced executive equity grants, aiming to align management’s interests with those of shareholders. Additionally, Avadel’s Phase 3 pivotal trial for LUMRYZ™, named REVITALYZ™, is progressing as planned, with full enrollment expected in the latter half of 2025. These developments underscore Avadel’s ongoing efforts to strengthen its market position and enhance shareholder value.

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