Avadel Pharmaceuticals plc AVDL announced that the FDA has approved its supplemental new drug application (sNDA) seeking label expansion of Lumryz.
The drug is now approved in the United States for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients aged seven years and older with narcolepsy.
The company’s shares rose 5.1% on the news.
The stock fell 1.4% year to date compared with the industry’s 0.7% decline.
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Label Expansion of AVDL’s Lumryz
Lumryz is a once-at-bedtime formulation extended-release sodium oxybate. It was first approved by the FDA on May 1, 2023, for the treatment of cataplexy or EDS in adult patients with narcolepsy.
Along with the approval, the FDA also granted seven years of orphan drug exclusivity to Lumryz for the treatment of cataplexy or EDS in adults with narcolepsy due to a finding of clinical superiority of Lumryz relative to currently available oxybate treatments.
Narcolepsy is a chronic neurological condition, wherein the brain's ability to regulate the sleep-wake cycle is impaired.
The latest FDA approval expands the drug’s indication for younger narcolepsy patients. The drug was also granted orphan drug exclusivity in pediatric narcolepsy patients aged seven years and older through Oct. 16, 2031.
Pediatric patients (seven years and older) living with narcolepsy will now have the same opportunity that adult patients with narcolepsy have — to choose a once-nightly treatment option that does not disrupt sleep for a middle-of-the-night dose.
Lumryz Uptake Boosts AVDL
Avadel generated $41.5 million of net product revenues from the sales of Lumryz in the second quarter of 2024.
As of June 30, there were more than 1,900 patients on Lumryz compared to more than 1,400 as of March 31.
Pediatric patients currently represent approximately 5% of all oxybate-treated narcolepsy patients. Hence, the label expansion of the drug for this population should boost sales.
In addition, a phase III double-blind, placebo-controlled, randomized withdrawal, multicenter study is evaluating the efficacy and safety of Lumryz in idiopathic hypersomnia (IH). Enrollment is open to patients who are currently being treated with a twice-nightly oxybate and those not taking oxybates. The study, which is expected to enroll approximately 150 adults diagnosed with IH, includes an open-label extension portion.
AVDL’s Rank & Other Stocks to Consider
Avadel carries a Zacks Rank #3 (Hold) at present. Some other top-ranked stocks in the drug/biotech sector are Catalyst Pharmaceuticals CPRX, ANI Pharmaceuticals ANIP and Alnylam Pharmaceuticals ALNY. While CPRX and ANIP carry a Zacks Rank #1 (Strong Buy) each, ALNY holds a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 90 days, estimates for Catalyst’s 2024 EPS have increased from $1.75 to $1.92. The consensus estimate for 2025 EPS has improved from $2.09 to $2.27 during the same period. Year to date, shares of CPRX have risen 25.9%.
Catalyst’s earnings beat estimates in three of the trailing four quarters and met the same once, the average surprise being 13.88%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.37 to $5.86. Year to date, shares of ANIP have risen 9%.
ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 31.32%.
In the past 60 days, estimates for Alnylam’s 2024 loss per share have narrowed from $1.20 to 63 cents. Loss per share estimates for 2025 have narrowed from 34 cents to 26 cents during the same period. Year to date, shares of ALNY have risen 55.1%.
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