Wolfe Research has begun coverage of Axsome Therapeutics Inc. (NASDAQ:AXSM) with an Outperform rating and set a $230.00 price target, emphasizing the company’s recent commercial performance and growing pipeline in central nervous system (CNS) disorders.
Auvelity remains the focal point. Wolfe noted that Axsome’s lead therapy, Auvelity - an oral agent described as a rapid-acting NMDA receptor antagonist and sigma-1 receptor agonist - is approved in the United States to treat major depressive disorder (MDD). In 2025, Auvelity generated approximately $507 million in sales for MDD, reflecting more than 73% year-over-year growth, the research firm said. That performance contributed to a 66% increase in the company’s revenue over the trailing 12 months and coincided with an elevated gross profit margin of 93%, according to InvestingPro data.
The product’s U.S. approval came in 2022, and the company expects loss of exclusivity in 2039, per the information Wolfe Research cited. The analyst team also underscored a notable regulatory milestone on the calendar: an application tied to an Alzheimer’s disease agitation indication (ADA) that carries a PDUFA date of April 30, 2026. ADA previously received breakthrough therapy designation in June 2020, and Wolfe pointed to label expansion in this area as a key upside opportunity.
Pipeline breadth and additional assets. Axsome’s broader portfolio also factored into Wolfe’s view. The company’s second marketed product, Sunosi, is approved to treat excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea, and it is supported by multiple late-stage studies aimed at expanding its approved uses. The recently approved Symbravo was highlighted as a potential niche treatment for acute migraine. Wolfe Research stated it favors Axsome’s strategy of assembling a diversified suite of CNS medicines, with new approvals and label expansions adding to the company’s growth thesis.
Market reaction and valuation commentary. The stock has rallied strongly, gaining about 47% over the past six months. Analysts collectively maintain a strong-buy consensus on the roughly $8.7 billion company. InvestingPro analysis cited by the research firm indicates the shares remain undervalued and pointed readers to a Pro Research Report for additional detail.
Recent operating results and analyst moves. Axsome reported robust fourth-quarter 2025 results, with Auvelity sales of $155.1 million, a 14% increase from the prior quarter. The company also recorded approximately 225,000 total prescriptions during the quarter, an 8% rise sequentially. Several Wall Street firms have adjusted their price targets upward amid these trends: RBC Capital lifted its target to $222, Guggenheim increased its target to $220 while maintaining a Buy rating, and TD Cowen moved its target to $215, citing prescription growth. Truist Securities reiterated a Buy rating with a $200 target.
Management activity tied to potential near-term launches was also noted. Axsome has dosed the first patient in its CLARITY Phase 3 trial of solriamfetol for patients with MDD and excessive daytime sleepiness symptoms. The company has expanded its salesforce by 300 representatives in advance of the FDA decision on its ADA application, and is preparing for a possible launch in Alzheimer’s disease agitation should approval be received.
Taken together, Wolfe Research’s initiation reflects conviction in Auvelity’s continued commercial momentum and in Axsome’s approach to building a multi-product CNS franchise. The firm’s $230 price target and Outperform rating rest on the combination of solid recent sales, high gross margins and potential label expansions and new indications that could drive further growth.
Summary of facts cited in this report:
- Wolfe Research initiated coverage with an Outperform rating and $230 price target.
- Auvelity sales for MDD were about $507 million in 2025, up more than 73% year-over-year.
- Company revenue rose 66% over the last twelve months and gross profit margin was 93% (InvestingPro data).
- Auvelity approved in 2022; loss of exclusivity expected in 2039.
- ADA received breakthrough therapy designation in June 2020; PDUFA date April 30, 2026.
- Other assets include Sunosi and Symbravo; multiple late-stage studies support label expansion for Sunosi.
- Q4 2025 Auvelity sales were $155.1 million, prescriptions totaled ~225,000, up 8% sequentially.
- Recent analyst price-target moves: RBC $222, Guggenheim $220, TD Cowen $215, Truist $200.
- Axsome dosed the first patient in the CLARITY Phase 3 solriamfetol trial and added 300 sales representatives ahead of the ADA decision.