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Why Shares of Axsome Therapeutics Slumped Today
The Motley Foolยท 2025-04-01 17:23
Core Viewpoint - Axsome Therapeutics' shares declined by 6% following the announcement of phase 3 trial results for solriamfetol in major depressive disorder (MDD) [1] Group 1: Trial Results - The phase 3 trial was a six-week proof-of-concept study for MDD, assessing patients with and without severe excess daytime sleepiness (EDS) [2] - The primary aim was to show significant improvement in the overall population, which included 51 patients with severe EDS and 295 without [2] - The trial did not demonstrate a statistical improvement in the overall population when comparing solriamfetol to placebo [5] Group 2: Implications for Patients - In MDD patients with severe EDS, solriamfetol showed clinically meaningful improvements compared to placebo on multiple efficacy measures, including the Montgomery-Asberg Depression Rating Scale (MADRS) [5] - The positive response in severe EDS cases has encouraged the company to plan a subsequent phase 3 trial in 2025 [3] Group 3: Investor Outlook - The mixed results from the trial led to a decline in stock value, as the primary aim was not met [4] - If the positive results in severe EDS cases are replicated in future trials, the company could claim success; however, approval limited to severe EDS would likely result in lower sales compared to broader approval for all EDS patients [4]