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Investing.com - Mizuho (NYSE:MFG) maintained its Outperform rating and $210.00 price target on Axsome Therapeutics (NASDAQ:AXSM) ahead of the company’s upcoming R&D Day.
The research firm noted that Axsome will host the event next Monday to showcase its late-stage central nervous system (CNS) pipeline, which includes four assets being developed across eight indications.
According to management guidance cited by Mizuho, these pipeline opportunities represent an incremental peak revenue opportunity of approximately $6-$13 billion.
Mizuho does not expect the R&D Day to serve as a significant catalyst for the stock but views any additional information regarding progress with the submission of the supplemental New Drug Application (sNDA) for AXS-05/Auvelity in Alzheimer’s disease agitation as an incremental positive.
The research firm maintains its view of favorable risk/reward for Axsome shares, with the official FDA acceptance of the AXS-05 sNDA and a potential priority review representing a near-term stock catalyst.
In other recent news, Axsome Therapeutics announced it will host its Frontiers in Brain Health R&D Day on July 21, 2025, in New York City. The event will focus on showcasing the company’s late-stage central nervous system pipeline, including its FDA-approved treatments and ongoing development programs. Morgan Stanley (NYSE:MS) has assumed coverage of Axsome with an Overweight rating, highlighting the company’s upcoming supplemental New Drug Application filing for AXS-05 in Alzheimer’s disease agitation. Piper Sandler reiterated its Overweight rating despite Axsome receiving a Refusal to File letter from the FDA for AXS-14, intended for fibromyalgia treatment. The FDA requested a confirmatory Phase III trial, which Axsome plans to initiate in the fourth quarter of 2025.
H.C. Wainwright maintained its Buy rating on Axsome with a $180 price target, viewing the FDA’s feedback as constructive for future approval. Oppenheimer adjusted its price target to $183 from $185, maintaining its Outperform rating on the stock. The firm noted that the market had not assigned significant value to AXS-14, suggesting limited impact from the FDA’s decision. Axsome’s focus is expected to remain on its other products, such as Auvelity and the upcoming Symbravo launch.
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