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ROCKVILLE, Md. - Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a biopharmaceutical company specializing in CNS diseases with an impressive 89% gross profit margin, has announced the FDA approval of a label update for its ADHD treatment, Qelbree. The company, currently valued at $2.1 billion and trading near its 52-week high, has received FDA approval for updated label information including new pharmacodynamic data and lactation study results. According to InvestingPro analysis, Supernus maintains strong financial health with more cash than debt on its balance sheet.
The new information in Section 12.2 of the label details Qelbree's partial agonist activity at the serotonin 5-HT2C receptor and its inhibition of the norepinephrine transporter. This multimodal pharmacodynamic profile is thought to contribute to the drug's mechanism of action, which primarily involves inhibiting norepinephrine reuptake.
Additionally, the label now reflects data from a lactation study following the 2019 FDA guidance on Clinical Lactation Studies. The study, which involved 15 healthy lactating women, assessed the transfer of Qelbree into breast milk. Findings show that the estimated daily infant dose of viloxazine, Qelbree's active ingredient, is low, suggesting minimal transfer to breastfed infants. This development comes as Supernus demonstrates solid revenue growth of 6.8% over the last twelve months, with analysts expecting continued profitability this year.
Qelbree is approved for treating ADHD in patients aged 6 years and older. The label update aims to provide healthcare professionals and patients with comprehensive information to support treatment decisions for those living with ADHD.
Dr. Stephen M. Stahl commented on the updated pharmacodynamic data, emphasizing its role in deepening the understanding of Qelbree's effects. Meanwhile, Supernus CEO Jack A. Khattar highlighted the company's commitment to evidence-based ADHD treatment options.
The label update does not change Qelbree's indication or safety information. It continues to warn of the potential for increased suicidal thoughts and actions in children and adults and advises monitoring mood and behavior changes during treatment.
This news is based on a press release statement from Supernus Pharmaceuticals. For investors seeking deeper insights, InvestingPro offers comprehensive analysis with 14 additional ProTips and a detailed research report, helping investors understand the company's full potential in the pharmaceutical sector. Based on InvestingPro's Fair Value calculations, the stock currently appears slightly undervalued.
In other recent news, Supernus Pharmaceuticals reported a notable increase in total revenue, reaching $175.7 million, primarily due to the growth of key products, Qelbree and GOCOVRI. Despite the overall strong performance, the company's legacy products, Trokendi XR and Oxtellar XR, saw a decline in net sales. The company's Q3 net product sales also rose significantly to $170.3 million.
The firm's Qelbree prescriptions experienced a 19% growth, while GOCOVRI net sales saw an 8% increase year-over-year. However, sales of Trokendi XR decreased by 26%. Supernus Pharmaceuticals has also raised its full-year 2024 revenue guidance to between $630 million and $650 million.
In other recent developments, the company anticipates continued erosion in sales for Trokendi XR but has raised its sales target for Trokendi XR and Oxtellar XR to approximately $155 million for 2024. The firm's GAAP operating earnings are forecasted to be between $50 million and $65 million, with non-GAAP operating earnings projected between $150 million and $170 million.
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