Axsome Therapeutics AXSM has been witnessing a strong sales uptake for its lead marketed drug, Auvelity (AXS-05), which is approved for treating major depressive disorder. Since its launch in the United States in 2022, the drug has played an instrumental role in driving the company’s top line.
Auvelity recorded sales worth $352 million in the first nine months of 2025, reflecting an increase of 77% on a year-over-year basis, driven by an increase in unit sales volume. Axsome recently reported preliminary results for the fourth quarter and full-year 2025.
The company expects total product revenues to be approximately $196 million for the fourth quarter and around $638.5 million for the full year, reflecting a year-over-year increase of 65% and 66%, respectively. Axsome’s product revenues comprise sales of its marketed drugs, Auvelity, Sunosi (solriamfetol) and the newest drug, Symbravo (meloxicam and rizatriptan).
Auvelity’s net product sales are expected to be around $155.1 million and $507.1 million for the fourth quarter and full-year 2025, respectively. The drug 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 the supplemental new drug application (“sNDA”) seeking approval for AXS-05 (dextromethorphan HBr and bupropion HCl) for the treatment of patients with AD agitation. With the FDA granting a priority review to the sNDA, a decision from the regulatory body is now expected on April 30, 2026.
A potential label expansion for Auvelity should help Axsome address a broader patient population and drive sales further in the future quarters.
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 in May 2022.
In the first nine months of 2025, Sunosi sales increased 29.1% on a year-over-year basis. The acquisition of Sunosi from Jazz diversified the company’s commercial portfolio. Sunosi net product revenues are anticipated to be around $36.7 million and $124.8 million for the fourth quarter and full-year 2025, respectively.
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 was launched in the United States in June 2025. Symbravo net product sales are expected to be around $4.1 million and $6.6 million for the fourth quarter and full-year 2025, respectively.
The approval of Symbravo further solidified Axsome’s commercial footprint in the target market. However, competition looms large.
AXSM’s Competition in the Target Market
While Axsome is benefiting from Auvelity’s success and other commercial efforts, the competitive landscape remains challenging, with some companies developing therapies for various CNS disorders. Acadia Pharmaceuticals ACAD is one such company that 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 $505.7 million, up 13% year over year, during the first nine months of 2025.
Sunosi is also likely to face competition from Jazz’s sleep disorder drugs, which hold a strong market share.
Meanwhile, Symbravo will likely encounter competition from established players in the migraine market, including Pfizer’s Nurtec ODT/Vydura and AbbVie’s Ubrelvy and Qulipta/Aquipta. These products are already widely prescribed and supported by a strong commercial infrastructure, which may pose adoption challenges for newer entrants. This is likely to induce acute competition for Axsome and might impact its longer-term growth trajectory.
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Jazz Pharmaceuticals PLC (JAZZ): Free Stock Analysis Report ACADIA Pharmaceuticals Inc. (ACAD): Free Stock Analysis Report Axsome Therapeutics, Inc. (AXSM): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).
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