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On Tuesday, BofA Securities analyst Jason Gerberry maintained a Buy rating on Axsome Therapeutics (NASDAQ:AXSM) with a price target of $174.00. Currently trading at $108.51, InvestingPro analysis suggests the stock is undervalued, with analyst targets ranging from $115 to $216. Gerberry highlighted the strong performance of Auvelity (or AXS-05) in the major depressive disorder (MDD) market and its potential for expansion into treating Alzheimer’s agitation as significant factors in the valuation of Axsome.
The analyst noted that while there are some investor concerns regarding the approval of the Auvelity-ADA indication, such as the lack of peer-reviewed publication for Phase 3 ADVANCE-1 trials and questions about the FDA’s view on randomized withdrawal studies, he believes the FDA supports these studies and assigns a 90% probability of success (POS) for ADA approval.
Looking forward, Gerberry sees Axsome as an "execution story" with few high-impact clinical or regulatory events expected in the next 12 months. The focus is on the continued successful launch of Auvelity for MDD and the upcoming launch of Symbravo for migraines in the second quarter of 2025. Post-intellectual property resolution, he anticipates Axsome shares will gain from the scarcity of high-growth, clinically de-risked psychiatry assets and a potential increase in large-cap pharma mergers and acquisitions in this sector. With a strong current ratio of 2.11 and a market cap of $5.27 billion, InvestingPro subscribers can access 12 additional key insights about AXSM’s financial health and growth potential.
In other recent news, Axsome Therapeutics has announced results from its Phase 3 PARADIGM trial evaluating solriamfetol for major depressive disorder (MDD) with severe excessive daytime sleepiness (EDS). While the overall patient population did not experience significant changes, a subgroup with severe EDS showed notable improvements in depressive symptoms. Axsome plans to conduct a Phase 3 trial specifically for MDD patients with EDS in 2025. Additionally, Axsome’s Phase 3 FOCUS trial for solriamfetol in treating ADHD reported a statistically significant reduction in symptoms with the 150 mg dose, although the 300 mg dose did not achieve statistical significance. Piper Sandler has maintained an Overweight rating with a $148 price target, while Mizuho (NYSE:MFG) Securities increased its price target to $216, maintaining an Outperform rating. Guggenheim also maintained its Buy rating with a $195 price target, expressing confidence in the drug’s potential despite mixed trial results. Axsome plans to extend research on solriamfetol to pediatric patients, aiming to support a New Drug Application for ADHD.
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