Axsome Therapeutics has released its complete financial results for the fourth quarter and the full fiscal year 2025. Preliminary figures, which were issued earlier, pointed to a significant revenue increase exceeding 60% year-over-year. The question for investors is whether this momentum provides a durable foundation for the company’s position in the central nervous system (CNS) therapeutics market.
Portfolio Performance and Revenue Drivers
For the full 2025 fiscal year, the company generated total revenue of $638.5 million, representing a substantial 66% gain. The fourth quarter alone saw net product revenue climb 65% to reach $196 million.
A key contributor to this performance was Auvelity, a treatment for major depressive disorder. The drug solidified its role as the company’s primary revenue pillar, delivering $155.1 million in sales during the final quarter. Sunosi, a medication for excessive daytime sleepiness, contributed an additional $36.7 million in the same period, further bolstering the quarterly results.
Upcoming Catalyst and Patent Security
Beyond the strong commercial execution, attention is turning to Axsome’s development pipeline. The U.S. Food and Drug Administration (FDA) is currently reviewing a supplemental New Drug Application (sNDA) for AXS-05, seeking its approval for the treatment of agitation associated with Alzheimer’s disease. This application is under priority review.
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A critical date for the company is April 30, 2026, which is the target action date for the FDA’s decision. Given the significant unmet medical need in this indication, a potential approval is viewed as a major potential growth driver for Axsome’s future.
In a separate development, the company has secured long-term commercial certainty for Sunosi through a patent litigation settlement. Market exclusivity for the drug is now protected until at least March 2040.
Management is scheduled to hold a conference call prior to the U.S. market open today, where further details on the operational outlook for the current fiscal year are expected to be discussed.
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