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Investing.com -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) shares fell sharply by 25% following the release of disappointing results from its Phase 2b study in adults with treatment-resistant depression. The company’s study did not meet the primary endpoint of showing a statistically significant improvement in depressive symptoms as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to placebo.
The Rockville, Maryland-based biopharmaceutical company, which specializes in the development and commercialization of products for central nervous system (CNS) diseases, shared the outcomes of the study on February 18, 2025. The trial aimed to assess the efficacy and safety of SPN-820, but it failed to demonstrate a treatment difference between the drug and placebo in reducing depressive symptoms over a four-week period.
President and CEO Jack Khattar expressed his disappointment in the trial’s outcomes, stating, "We are disappointed that the trial did not meet its primary endpoint in this patient population." Khattar also extended his gratitude to everyone involved in the trial and mentioned that the company would continue to analyze the data and discuss the future of the program with their development partner, Navitor Pharmaceuticals.
The study’s results are particularly noteworthy as they were part of a multi-center, randomized, double-blind, placebo-controlled trial involving approximately 250 patients across roughly 40 clinical sites. Despite the setback, the safety profile of SPN-820 was consistent with previous clinical trials, showing few adverse events.
Investors reacted to the news by selling off the stock, leading to the significant drop in Supernus Pharma’s market value during the trading session. The failure to meet the primary endpoint in such a critical study represents a considerable hurdle for the company, which will now have to reassess the path forward for SPN-820 in the treatment of treatment-resistant depression.
This development is a significant blow to Supernus Pharma’s prospects, as treatment-resistant depression represents an area of high unmet medical need, and successful treatments in this space can be of substantial value to pharmaceutical companies. The company has not provided any additional guidance on its next steps following the trial results.
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