AXSM's 2025 Revenue Surge Largely Driven by Auvelity: What's Ahead?

Axsome Therapeutics AXSM has been witnessing strong uptake for its lead marketed drug, Auvelity (AXS-05), which is approved for treating major depressive disorder. The drug has played an instrumental role in driving the company’s top line since its approval and launch in the United States in 2022.

In 2025, Auvelity recorded sales of $507.1 million, up around 74% year over year in the United States. The drug’s sales are being driven by an increase in unit sales volume, and the momentum is likely to continue as 2026 progresses.

Auvelity is also being developed in several label expansion studies for other central nervous system (CNS) disorders like Alzheimer’s disease (AD), agitation and smoking cessation.

The FDA recently accepted Axsome’s supplemental new drug application (“sNDA”) seeking approval for AXS-05 for the treatment of patients with Alzheimer’s disease agitation. With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected on April 30, 2026.

A potential FDA nod to Auvelity label expansion should help Axsome address a broader patient population and drive sales further in 2026.

Axsome also plans to start a pivotal phase II/III study of AXS-05 for treating smoking cessation in the second quarter of 2026.

Besides Auvelity, Axsome’s narcolepsy drug, Sunosi (solriamfetol), is also generating incremental sales and aiding the top line. Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals JAZZ.

Sunosi generated sales worth $124.8 million in 2025, reflecting an increase of 32% on a year-over-year basis. The acquisition of Sunosi from Jazz diversified the company’s commercial portfolio. The drug has become an important revenue driver for Axsome.

Axsome’s newest product, Symbravo, was approved by the FDA for the acute treatment of migraine with or without aura in adults in January 2025. The drug, which was launched in the United States in June 2025, recorded $6.6 million in sales in 2025.

The approval of Symbravo further solidified Axsome’s commercial footprint in the target market. However, increasing competition in the target market remains an overhang for the company.

AXSM’s Competition in the Target Market

Although Axsome is benefiting from Auvelity’s momentum and its broader commercial portfolio, the CNS space remains highly competitive. Acadia Pharmaceuticals ACAD currently markets its lead drug, Nuplazid (pimavanserin), for a CNS disorder.

ACAD’s Nuplazid was the first and only drug approved by the FDA for hallucinations and delusions associated with Parkinson’s disease psychosis. The ACAD drug recorded sales worth $691.9 million in 2025, up 14.7% year over year.

Sunosi is also likely to face competition from Jazz’s sleep disorder drugs, which hold a strong market share.

Symbravo is also expected to face stiff competition in the migraine market from established players such as Pfizer’s Nurtec ODT/Vydura and AbbVie’s Ubrelvy and Qulipta/Aquipta. This could intensify competition for Axsome and potentially affect its long-term growth prospects.

AXSM’s Price Performance, Valuation and Estimates

Year to date, shares of Axsome have declined 15.6% against the industry’s increase of 5.7%.

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From a valuation standpoint, Axsome is trading at a premium to the industry. Going by the price-to-sales (P/S) ratio, the company’s shares currently trade at 12.22, higher than 2.45 for the industry. The stock is trading below its five-year mean of 14.41.

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The Zacks Consensus Estimate for 2026 has moved from earnings of 34 cents per share to a loss of $1.29 per share over the past 30 days. During the same time frame, earnings per share estimates for 2027 have decreased from $5.85 to $5.12.

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AXSM Zacks Rank

Axsome currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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