Strong Sales Drive 61.79% Revenue Growth – Auvelity, Symbravo & Sunosi

Axsome Therapeutics reported significant financial gains in the second quarter of August 2025, driven by robust sales of its central nervous system (CNS) medications. The company’s total net product revenue reached $150.0 million, a 72% increase compared to the same period in August 2024.

Auvelity Leads Growth

The primary driver of this growth was Auvelity (AXS-05), a medication for major depressive disorder, which generated net product sales of $119.6 million – an 84% year-over-year increase. Sales volume continues to rise, suggesting strong demand for the treatment. Auvelity is also being investigated for potential use in other neurological conditions, including Alzheimer’s disease agitation and smoking cessation.

A supplemental New Drug Application (sNDA) for Auvelity in Alzheimer’s disease agitation is on track for submission to the Food and Drug Administration (FDA) in the third quarter of July 2025. A pivotal phase II/III study evaluating Auvelity for smoking cessation is anticipated to begin in the fourth quarter of October 2025.

Sunosi and Symbravo Contribute to Revenue

Beyond Auvelity, Axsome’s portfolio includes Sunosi (solriamfetol), a treatment for excessive daytime sleepiness, which contributed $30.0 million in net product revenue, representing a 35% increase year-over-year. Axsome acquired U.S. Rights to Sunosi from Jazz Pharmaceuticals in May 2022, diversifying its commercial offerings.

The recently launched Symbravo (meloxicam and rizatriptan), approved in January 2025 for the acute treatment of migraine with or without aura, generated $0.4 million in net product sales during the second quarter. While a modest contribution initially, the company anticipates increased uptake as market access expands.

Expanding Market Access

Axsome has been actively working to broaden access to its medications. Market access for Auvelity has been expanded to cover an additional 28 million lives in the commercial channel. The company also secured its first group purchasing organization (GPO) contract for Symbravo, which is expected to facilitate wider adoption of the migraine treatment. Currently, Symbravo has coverage for 38% of all covered lives.

Financial Overview

Despite the revenue growth, Axsome reported a net loss of $48.0 million ($0.97 per share) for the second quarter. However, this represents an improvement compared to the $79.3 million net loss reported in the second quarter of August 2024. The company maintains a strong cash position, with reserves of $303.0 million, which it believes is sufficient to fund operations until it reaches cash flow positivity.

“Axsome delivered robust second quarter performance, reflecting strong underlying demand for our life-changing medicines, exacting commercial execution, solid regulatory progress, and continued advancement of our differentiated neuroscience pipeline,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. “We are excited by the recent approval and launch of SYMBRAVO for migraine, and are pleased with the accelerating performance of AUVELITY for depression and SUNOSI for excessive daytime sleepiness.”

Looking Ahead

Axsome’s continued success appears heavily reliant on the performance of Auvelity. The potential for label expansion into Alzheimer’s disease agitation and smoking cessation represents significant growth opportunities. The company’s pipeline also includes AXS-12, a treatment for cataplexy in patients with narcolepsy, with an anticipated New Drug Application (NDA) submission to the FDA in the fourth quarter of October 2025.

The company’s focus on CNS disorders, coupled with its expanding commercial portfolio and pipeline, positions it for continued growth, although maintaining profitability remains a key challenge. The upcoming regulatory decisions regarding Auvelity’s expanded indications will be crucial in determining the company’s future trajectory.