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.
Auvelity generated $333 million in sales in the first half of 2026, up 54.2% year over year in the United States. Building on this momentum, we expect investors to closely watch Auvelity’s sales performance when Axsome reports its third-quarter 2026 results on Nov. 2.
Auvelity sales are likely to have been driven by prescription growth and higher volumes during the third quarter.
The drug is also being developed in several label expansion studies for other central nervous system (CNS) disorders like Alzheimer’s disease agitation and smoking cessation.
In April 2026, the FDA approved Auvelity for the treatment of agitation associated with dementia due to Alzheimer’s disease. The company commercially launched Auvelity for this indication in June 2026.
Axsome recently initiated the phase III SUMMIT study evaluating Auvelity for smoking cessation in August 2026.
The successful commercialization of Auvelity in additional indications would help the drug address a broader patient population and drive sales further in future quarters.
AXSM’s Other Marketed Drugs Support Growth
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 $66.5 million in the first half of 2026, reflecting an increase of 25.5% year over year. The acquisition of Sunosi from Jazz diversified Axsome’s commercial portfolio. The drug has become an important revenue driver for the company.
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 sales worth $6.3 million in the first six months of 2026.
The approval of Symbravo further solidified Axsome’s commercial footprint in the target market. However, increasing competition in the target market remains a concern 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 $350.1 million in first-half 2026, up 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.
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This article originally published on Zacks Investment Research (zacks.com).