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On Tuesday, Mizuho (NYSE:MFG) Securities reiterated its Outperform rating on Axsome Therapeutics (NASDAQ:AXSM) shares, maintaining a price target of $216.00. The company, currently trading at $109.38 with a market capitalization of $5.27 billion, has demonstrated impressive growth with revenue increasing 42.53% over the last twelve months. The decision follows the announcement of top-line results from the Phase 3 PARADIGM study of solriamfetol for the treatment of major depressive disorder (MDD). While the study did not meet statistical significance in the overall patient population, a subgroup of patients with severe excessive daytime sleepiness (EDS) showed greater improvement in depressive symptoms.
Axsome Therapeutics plans to initiate a new Phase 3 study focusing on MDD patients with EDS, based on these findings. Ahead of the market opening on Tuesday, Axsome’s stock showed a slight decline, trading down approximately 2-4% in pre-market action. However, Mizuho analysts anticipate that any weakness in the stock price following the negative study outcome will be limited, citing already modest expectations for the trial’s success.
The analysts at Mizuho remain confident in the long-term prospects of Axsome Therapeutics, highlighting the potential for up to four new product launches by the end of 2026. They view the company as one of the most promising growth stories within their coverage and suggest that investors consider taking advantage of any continued stock price weakness. Despite the setback in the PARADIGM study, the firm’s positive outlook on Axsome remains unchanged.
In other recent news, Axsome Therapeutics reported promising results from its Phase 3 PARADIGM trial, evaluating solriamfetol for major depressive disorder (MDD) with severe excessive daytime sleepiness (EDS). The trial showed significant improvements in depressive symptoms for a subgroup with severe EDS, leading to plans for a dedicated Phase 3 trial for this subgroup in 2025. Additionally, Axsome’s Phase 3 FOCUS study on solriamfetol for attention deficit hyperactivity disorder (ADHD) revealed that the 150 mg dose met its primary endpoint, although the 300 mg dose did not show statistical superiority over placebo.
Analysts have responded positively to these developments. Piper Sandler maintained an Overweight rating with a $148 target, seeing potential in solriamfetol’s use for ADHD. Mizuho Securities raised its price target for Axsome to $216, citing optimism about solriamfetol as a non-stimulant ADHD treatment and increasing the probability of success to 75%. Guggenheim also maintained a Buy rating with a $195 target, emphasizing the drug’s safety profile and potential despite mixed trial results. Meanwhile, BofA Securities kept a Buy rating with a $174 target, focusing on the strong performance of Axsome’s Auvelity in the major depressive disorder market and its potential expansion into treating Alzheimer’s agitation. These developments reflect a cautiously optimistic outlook among analysts regarding Axsome’s ongoing research and future prospects.
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