ROCKVILLE, MD – Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) disclosed today that its Phase 2a clinical trial of SPN-820, a treatment for adults with major depressive disorder, has shown promising results. According to the data furnished in the SEC Form 8-K, the study participants experienced a rapid response to the treatment.
The trial's findings indicate that 50% of participants achieved a significant reduction in depression symptoms, as measured by the Montgomery Åsberg Depression Rating Scale (MADRS), within four hours of treatment. Furthermore, the remission rate, defined as a MADRS score of 10 or less, was 35% at the same time point. By Day 10, these rates improved to 84.2% for response and 63.2% for remission.
The results of this exploratory open-label study are not deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor will they be incorporated by reference in any filing under the Securities Act of 1933, except as expressly set forth by specific reference in such a filing.
Supernus, headquartered in Rockville, Maryland, specializes in developing and commercializing products for the treatment of central nervous system diseases. The company's focus on innovative therapies is reflected in its ongoing research and clinical trials.
The announcement today is based on a press release statement and provides a glimpse into the potential impact of SPN-820 on the treatment of major depressive disorder. For investors and stakeholders, these findings may signal Supernus's commitment to addressing significant unmet medical needs within the field of mental health.
Timothy C. Dec, Senior Vice President and Chief Financial Officer of Supernus Pharmaceuticals, signed the SEC filing, ensuring the company's compliance with regulatory requirements. As the trial progresses, further updates are anticipated regarding the efficacy and safety of SPN-820 in treating depressive symptoms.
In other recent news, Supernus Pharmaceuticals has reported significant developments. The company released positive topline data from a Phase IIa trial in Major Depressive Disorder (MDD), showing significant improvement in patients' depression symptoms. This news follows Supernus's robust growth in Q2 2024, with a 24% year-over-year increase in total revenue, reaching $168.3 million, primarily driven by increases in prescriptions and net sales of key products Qelbree and GOCOVRI. The company subsequently raised its full-year 2024 financial guidance to a range of $600 million to $625 million.
TD Cowen maintained a Buy rating on Supernus, while Piper Sandler downgraded the stock from Overweight to Neutral, both influenced by recent developments. The U.S. Food and Drug Administration has also accepted Supernus's resubmitted new drug application for SPN-830, a device designed for continuous treatment of Parkinson's disease motor fluctuations, with a review date set for February 1, 2025.
InvestingPro Insights
The promising results from Supernus Pharmaceuticals' Phase 2a clinical trial for SPN-820 align with the company's strong financial position and market performance. According to InvestingPro data, Supernus boasts a market capitalization of $1.93 billion and has seen impressive price returns, with a 45.55% increase over the past year. This positive momentum is reflected in the stock trading near its 52-week high, at 98.06% of that peak.
InvestingPro Tips highlight Supernus's financial strength, noting that the company "holds more cash than debt on its balance sheet." This solid financial footing could be crucial for supporting ongoing research and development efforts, including the advancement of SPN-820 through clinical trials.
The company's focus on innovative therapies for central nervous system diseases is complemented by its robust gross profit margins, which InvestingPro data shows at an impressive 88.34% for the last twelve months as of Q2 2024. This financial efficiency may provide Supernus with the resources needed to continue its research initiatives and potentially bring new treatments like SPN-820 to market.
For those interested in a deeper analysis, InvestingPro offers 11 additional tips for Supernus Pharmaceuticals, providing further insights into the company's financial health and market position.
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