ROCKVILLE, Md. - Supernus Pharmaceuticals, Inc. (NASDAQ: NASDAQ:SUPN) reported findings from a Phase 2a clinical study of SPN-820, a novel treatment for major depressive disorder (MDD). The study indicated a rapid and significant reduction in depressive symptoms among adults when used as an adjunct to existing antidepressant therapy.
The open-label trial involved 40 subjects with MDD, 38 of whom completed the 10-day treatment period with SPN-820, dosed at 2400 mg every three days. The results showed a clinically meaningful improvement in depression ratings, with a decrease in the Hamilton Depression Rating Scale-6 Items (HAM-D6) total score by 9.6 points at Day 10, and a reduction in the Montgomery Åsberg Depression Rating Scale (MADRS) total score by 22.9 points at Day 10. Additionally, suicidal ideation was significantly reduced by 80% by the end of the study.
SPN-820 was generally well-tolerated, with a low discontinuation rate due to adverse events (AEs) at 2.5%. The most common AEs related to the drug were headache, nausea, somnolence, and dizziness, with some participants also experiencing cognitive disorder, dry mouth, fatigue, nasal decongestion, and paresthesia oral.
Jack Khattar, President and CEO of Supernus, expressed optimism about the potential of SPN-820 as a rapid and tolerable treatment option for depression. The company anticipates completing enrollment for a Phase 2b randomized double-blind placebo-controlled study in November, with topline results expected in the first half of 2025.
SPN-820 is an orally active small molecule designed to enhance synaptic activity and cellular metabolism in the brain through modulation of the mechanistic target of rapamycin complex 1 (mTORC1). It aims to offer a rapid-onset antidepressant response without dissociative side effects commonly associated with other treatments.
Supernus specializes in CNS disease treatments, with a portfolio that includes therapies for epilepsy, migraine, ADHD, and Parkinson's disease, among others. The company will host a webcast today to discuss the topline results from the SPN-820 study.
The information in this article is based on a press release statement from Supernus Pharmaceuticals, Inc.
In other recent news, Supernus Pharmaceuticals reported robust growth in Q2 2024, with a 24% year-over-year increase in total revenue, reaching $168.3 million. This growth was driven by significant increases in prescriptions and net sales of key products Qelbree and GOCOVRI. Despite generic competition for Trokendi XR, Supernus raised its full-year 2024 financial guidance to a range of $600 million to $625 million.
Piper Sandler downgraded Supernus Pharmaceuticals' stock from Overweight to Neutral and cut its price target to $36. The decision was influenced by the company's recent performance, particularly concerning its product Qelbree, whose anticipated surge in prescriptions fell short of expectations.
The U.S. Food and Drug Administration (FDA) has accepted the resubmitted new drug application for SPN-830, a device designed for continuous treatment of Parkinson's disease motor fluctuations. The FDA has set a target action date of February 1, 2025, for its review.
Supernus Pharmaceuticals maintains a strong balance sheet with no debt and $347.2 million in cash, cash equivalents, and marketable securities. The company is confident in the approval of SPN-830 and anticipates positive updates on SPN-817 and SPN-820.
InvestingPro Insights
Supernus Pharmaceuticals' recent clinical study results for SPN-820 align with the company's strong position in the CNS disease treatment market. According to InvestingPro data, Supernus boasts impressive gross profit margins of 88.34% for the last twelve months as of Q2 2023, reflecting its efficiency in producing and selling its specialized pharmaceuticals.
The company's focus on innovative treatments like SPN-820 is supported by its solid financial footing. An InvestingPro Tip highlights that Supernus holds more cash than debt on its balance sheet, providing financial flexibility to fund ongoing research and development efforts.
Despite a slight revenue decline of 0.61% over the last twelve months, Supernus has shown strong recent performance with a 24.17% quarterly revenue growth in Q2 2023. This growth, coupled with the potential of SPN-820, may contribute to the InvestingPro Tip indicating that net income is expected to grow this year.
Investors seem optimistic about Supernus's prospects, as evidenced by the stock trading near its 52-week high and showing a strong return of 17.37% over the last three months. However, it's worth noting that the company is trading at a high earnings multiple, suggesting that market expectations are already quite high.
For those interested in a deeper dive into Supernus Pharmaceuticals' financial health and market position, InvestingPro offers 11 additional tips, providing a comprehensive view of the company's investment potential.
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