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On Tuesday, Guggenheim reiterated its Buy rating on Axsome Therapeutics (NASDAQ:AXSM) shares with a price target of $195.00. According to InvestingPro data, analyst targets range from $115 to $216, with the stock currently trading at $108.65. The company has demonstrated strong market performance, with a 51.49% return over the past year and appears undervalued based on InvestingPro’s Fair Value analysis. The reaffirmation follows Axsome’s announcement that its Phase III PARADIGM study, which evaluated solriamfetol in Major Depressive Disorder (MDD) patients with and without severe Excessive Daytime Sleepiness (EDS), did not meet its primary endpoint. The study failed to show a statistically significant change in the Montgomery-Åsberg Depression Rating Scale (MADRS) at week 6.
Guggenheim noted that the lack of statistically significant results was not unexpected, as the proof of concept for this mechanism is yet to be established and MDD studies have historically been challenging. Despite the overall results, a small subgroup of patients with severe EDS did show greater improvement in depressive symptoms compared to the placebo group. However, the study was not sufficiently powered for statistical significance. InvestingPro data shows the company maintains impressive gross profit margins of 91.37% and operates with a moderate level of debt, with liquid assets exceeding short-term obligations.
Axsome Therapeutics stated that based on these findings, it plans to initiate a new Phase III study in MDD patients with EDS in 2025. Currently, Axsome’s Sunosi is approved for improving wakefulness in adults with narcolepsy or obstructive sleep apnea, with a maximum recommended daily dose of 150mg. The PARADIGM study tested a 300mg dose and reported a safety and tolerability profile consistent with the existing medication label.
The company also reported positive Phase III results for adult ADHD patients last week. Despite concerns over the lack of a dose-response relationship, Axsome intends to conduct a second Phase III ADHD study in pediatric patients later in the year. Guggenheim stated that neither ADHD nor MDD are included in their current financial model for Axsome, so any success in these areas could potentially provide an upside to their estimates. With revenue growth of 42.53% in the last twelve months and a market capitalization of $5.27 billion, investors can access detailed analysis and 12 additional ProTips through InvestingPro’s comprehensive research reports.
In other recent news, Axsome Therapeutics has been in the spotlight following several developments. The company announced results from its Phase 3 PARADIGM trial, which evaluated solriamfetol for major depressive disorder (MDD) with severe excessive daytime sleepiness (EDS). While the overall results did not show statistical significance, a subgroup with severe EDS demonstrated notable improvements, prompting plans for a new Phase 3 study. In another study, the Phase 3 FOCUS trial for solriamfetol in treating ADHD showed positive outcomes, particularly at the 150 mg dose, leading to further optimism about its potential application.
Analyst firms have responded to these developments with various ratings and targets. Mizuho (NYSE:MFG) Securities maintained an Outperform rating on Axsome, raising their price target to $216.00, reflecting optimism about solriamfetol’s prospects in ADHD treatment. Piper Sandler also reaffirmed an Overweight rating with a $148.00 target, citing the drug’s potential in the ADHD market. Meanwhile, BofA Securities maintained a Buy rating with a $174.00 target, emphasizing the strong performance of Auvelity in the MDD market and its potential expansion into treating Alzheimer’s agitation.
These analyst ratings highlight a generally positive outlook on Axsome’s growth potential, despite some mixed trial results. The company’s focus on advancing its drug pipeline, including the upcoming launch of Symbravo for migraines, remains a key point of interest for investors. Axsome’s ongoing studies and planned launches are being closely watched as they continue to navigate the complex landscape of CNS disorder treatments.
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