Axsome Therapeutics Inc. (NASDAQ:AXSM) shares advanced 2.13% in pre-market trading on Monday after the biopharmaceutical company reported third-quarter 2026 financial results that exceeded analyst expectations, supported by strong sales growth for its AUVELITY and SUNOSI treatments.
Quarterly revenue increased 52% year over year to $259.7 million, exceeding the consensus estimate of $252.7 million and rising from $171.0 million in the corresponding period of 2025.
The company reported a loss of $0.25 per share, narrower than the $0.58 per-share loss anticipated by analysts.
Growth was primarily driven by increased demand for AUVELITY, which generated net product sales of $207.6 million, while SUNOSI contributed $48.2 million.
Axsome also reported higher prescription volumes for AUVELITY and provided updates on its clinical development programmes, including upcoming regulatory milestones for AXS-12 and ongoing Phase 3 testing of AXS-05.
Axsome delivered third-quarter revenue of $259.7 million, approximately $7 million above the analyst consensus of $252.7 million.
The result represented a 52% increase from the $171.0 million reported in the third quarter of 2025.
The company’s loss per share of $0.25 was also smaller than the consensus forecast of $0.58, representing a positive earnings surprise of $0.33 per share.
The stronger-than-expected performance reflected continued commercial growth across Axsome’s marketed pharmaceutical products.
AUVELITY and SUNOSI remained the principal contributors to revenue, with both products reporting substantial year-on-year increases in net sales.
The results also indicated that Axsome’s quarterly revenue had moved above the level equivalent to a $1 billion annualised run rate.
AUVELITY remained Axsome’s largest revenue contributor during the third quarter.
Net product sales reached $207.6 million, representing an increase of 53% compared with the same period last year.
The treatment accounted for approximately 80% of Axsome’s total quarterly revenue.
The sales growth was supported by increased prescription activity and continued expansion in the number of patients receiving the treatment.
AUVELITY is marketed for the treatment of major depressive disorder in adults.
The latest figures indicate continued commercial momentum for the product, which has become a central component of Axsome’s revenue growth.
The company also reported strong increases in new patient prescriptions, including particularly substantial growth among adults aged 65 and older.
Total AUVELITY prescriptions reached approximately 302,000 during the third quarter, an increase of 40% from the corresponding period in 2025.
New-to-brand prescriptions, which represent new patient starts, increased 44% year over year.
The growth in new prescriptions indicates continued expansion in the treatment’s patient base alongside increased overall prescribing activity.
Axsome also reported significant growth in AUVELITY prescriptions among older adults.
For patients aged 65 and above, new-to-brand prescriptions increased 211% compared with the third quarter of 2025.
Total prescriptions within the same age group rose 101% year over year.
These figures suggest that the treatment experienced particularly strong growth among older patients during the reporting period.
However, the announcement did not provide absolute prescription volumes for the 65-and-over age group.
Axsome’s SUNOSI product also delivered strong sales growth during the quarter.
Net product revenue increased 47% year over year to $48.2 million.
SUNOSI is used to improve wakefulness in adults experiencing excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnoea.
The product contributed approximately 19% of Axsome’s total quarterly revenue.
The increase in SUNOSI sales complemented the growth recorded by AUVELITY and helped support the company’s overall 52% revenue expansion.
Together, AUVELITY and SUNOSI generated $255.8 million in net product revenue during the third quarter.
The performance demonstrates the importance of Axsome’s existing commercial portfolio as the company continues investing in additional treatments under development.
Chief Executive Officer Herriot Tabuteau, MD, highlighted the company’s commercial performance and continued revenue expansion.
“Axsome delivered 52% year-over-year total revenue growth in the third quarter, surpassing a one-billion-dollar annual run rate,” Tabuteau said.
The milestone reflects quarterly revenue exceeding $250 million, equivalent to more than $1 billion when annualised.
The annualised figure illustrates the scale of Axsome’s current quarterly revenue but does not represent a full-year revenue forecast.
The company’s results were supported by higher sales of AUVELITY and SUNOSI, alongside continued prescription growth.
Management’s comments emphasised the commercial progress achieved during the quarter as Axsome advances its broader pharmaceutical development pipeline.
Axsome continued investing in clinical development programmes during the third quarter.
Research and development expenses increased to $50.6 million from $40.2 million in the corresponding period last year.
The increase of $10.4 million reflected costs associated with ongoing clinical programmes.
The company is developing additional treatments targeting central nervous system conditions, including smoking cessation and cataplexy associated with narcolepsy.
These programmes form part of Axsome’s strategy to expand its pharmaceutical portfolio beyond its currently marketed products.
The higher research spending reflects continued investment in clinical trials and regulatory development activities.
However, the announcement did not provide a detailed breakdown of expenditure by individual development programme.
Selling, general and administrative expenses also increased during the quarter.
Axsome reported SG&A expenses of $203.1 million, compared with $150.2 million in the third quarter of 2025.
The increase of $52.9 million was primarily attributed to commercialisation activities involving AUVELITY and SYMBRAVO.
The higher spending reflects the company’s continued investment in supporting its marketed products and expanding commercial operations.
These costs accompanied the substantial increase in product revenue during the quarter.
Although Axsome reported a narrower-than-expected loss per share, the rise in operating expenses indicates that commercial expansion and clinical development continue to require significant investment.
The company did not provide additional details about the individual contributions of AUVELITY and SYMBRAVO to the increase in SG&A expenses.
Axsome also provided an update on its clinical pipeline, confirming that it initiated the SUMMIT Phase 3 trial of AXS-05 in August 2026.
The study is evaluating AXS-05 as a potential treatment for smoking cessation.
The company expects topline results from the trial during the second half of 2027.
Phase 3 studies are designed to evaluate the efficacy and safety of investigational treatments in larger patient populations and can provide important evidence for regulatory submissions.
The SUMMIT trial represents a significant development milestone for Axsome’s smoking cessation programme.
However, the treatment remains investigational for this indication, and the outcome of the trial has not yet been determined.
The expected results will provide further information about the potential regulatory and commercial prospects of AXS-05 in smoking cessation.
Axsome also highlighted an upcoming regulatory milestone involving AXS-12.
The company’s New Drug Application (NDA) for AXS-12, being developed to treat cataplexy in patients with narcolepsy, has a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027.
The date represents the US Food and Drug Administration’s target for completing its review of the application.
Cataplexy is characterised by sudden episodes of muscle weakness associated with narcolepsy.
AXS-12 is being evaluated as a potential treatment for this condition.
The regulatory review represents an important upcoming milestone for Axsome’s development pipeline.
However, the PDUFA date is a target for regulatory action and does not guarantee approval.
The outcome will depend on the FDA’s assessment of the submitted application.
Axsome’s third-quarter results demonstrated continued commercial growth, with revenue increasing 52% to $259.7 million and the reported loss per share coming in narrower than expected.
AUVELITY remained the primary growth driver, generating $207.6 million in quarterly sales, while SUNOSI revenue increased to $48.2 million.
Prescription trends also remained strong, particularly for AUVELITY, where total prescriptions increased 40% and new-to-brand prescriptions rose 44%.
The company’s expanding commercial operations and clinical development activities contributed to higher research and administrative expenses.
Looking ahead, investors will be monitoring continued sales growth for AUVELITY and SUNOSI, alongside developments in Axsome’s clinical pipeline.
Key upcoming milestones include the May 1, 2027, FDA target action date for AXS-12 and the anticipated second-half 2027 results from the SUMMIT Phase 3 trial of AXS-05.
The company’s quarterly revenue performance indicates that its commercial portfolio has reached an annualised revenue run rate above $1 billion, although future results will depend on continued prescription growth, operating expenditure and the progress of its development programmes.
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