Axsome Therapeutics Inc NASDAQ:AXSM Price, Chart, News & Insight

Axsome Therapeutics Falls 9.6% Despite 52% Revenue Growth as Spending Remains Elevated

Axsome Therapeutics (NASDAQ: AXSM) shares fell about 9.6% despite reporting strong third-quarter 2026 product growth and a sharply narrower net loss.

Total net product revenue increased 52% year over year to $259.7 million, surpassing a $1 billion annualized run rate. AUVELITY remained the main growth driver, with sales rising 53% to $207.6 million.

SUNOSI revenue increased 47% to $48.2 million, including $8.5 million of milestone revenue, while SYMBRAVO sales rose 88% to $3.9 million from a relatively small base.

The bottom line improved substantially. Net loss narrowed to $12.9 million, or $0.25 per share, from $47.2 million, or $0.94 per share, a year earlier. However, operating expenses remained high. R&D expense increased to $50.6 million from $40.2 million, while SG&A climbed to $203.1 million from $150.2 million as the company continued to invest in clinical programs and commercialization.

Axsome ended the quarter with $313.9 million in cash and cash equivalents, compared with $322.9 million at the end of 2025. Management said existing liquidity should be sufficient to fund operations through cash flow positivity under its current plan.

The company also initiated the Phase 3 SUMMIT trial of AXS-05 in smoking cessation, adding another potential indication to its CNS pipeline.

The 9.6% decline appears to reflect investor concern over the company’s still-heavy spending profile and the quality of some reported growth, including milestone revenue within SUNOSI, rather than weakness in underlying product demand. AUVELITY growth remains strong and losses are narrowing, but the market reaction suggests investors were looking for faster operating leverage or a cleaner path toward sustained profitability.

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WS Investor 11-02-26

Axsome Therapeutics Stock Rises 2.5% as Q2 Revenue Jumps 46% on Strong AUVELITY Growth

Axsome Therapeutics (NASDAQ: AXSM) shares rose about 2.5% Monday after the CNS-focused biopharmaceutical company reported strong second-quarter revenue growth, led by continued momentum for AUVELITY and progress across its late-stage pipeline.

Total net product revenue increased 46% year over year to $218.4 million from $150 million. AUVELITY remained the main growth engine, with sales jumping 51% to $180.3 million, while SUNOSI revenue increased 20% to $35.8 million.

SYMBRAVO, launched in June 2025, generated $2.3 million in quarterly sales, up from $0.4 million a year earlier.

AUVELITY Growth Accelerates After Alzheimer’s Agitation Launch

A key positive for investors was the early performance of AUVELITY following its June launch for agitation associated with dementia due to Alzheimer’s disease.

Among patients aged 65 and older, new-to-brand prescriptions increased 126% during the first eight weeks following the launch compared with the same period of the previous quarter.

Overall AUVELITY new-to-brand prescriptions increased 26% sequentially, while approximately 266,000 prescriptions were written during the quarter, up 34% year over year and 12% from the first quarter.

The drug currently has payer coverage across approximately 89% of covered lives, including 100% in Medicare and Medicaid channels.

Higher Commercial Spending Keeps Axsome in the Red

Rapid commercial expansion is coming with significantly higher expenses. SG&A spending jumped to $208.1 million from $130.3 million a year earlier, primarily reflecting AUVELITY sales-force expansion, the Alzheimer’s agitation launch and SYMBRAVO commercialization.

Axsome consequently reported a net loss of $51.3 million, or $0.99 per share, compared with a $48 million loss a year earlier.

Cash and equivalents stood at $319.9 million at the end of June. Importantly, management said its existing cash position should be sufficient to fund operations through cash-flow positivity under its current operating plan.

Pipeline Adds Another Catalyst

Axsome also reported progress beyond its commercial portfolio. The FDA accepted the company's NDA for AXS-12 for cataplexy in narcolepsy and set a PDUFA target action date of May 1, 2027.

The company has also initiated the FOCUS-2 and FOCUS-3 Phase 3 trials evaluating solriamfetol in children and adolescents with ADHD.

The roughly 2.5% gain in AXSM stock suggests investors are focusing on the accelerating commercial trajectory, particularly AUVELITY's 51% sales growth and encouraging early adoption in Alzheimer’s agitation. Rising commercialization expenses remain a near-term consideration, but strong prescription trends, substantial revenue growth and additional regulatory catalysts provide support for Axsome's longer-term growth story.

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European Investor 08-10-26

Axsome Therapeutics Shares Surge After FDA Priority Review Boosts Outlook

Shares of Axsome Therapeutics rallied sharply this week following a major regulatory catalyst, drawing renewed investor attention to the company’s central nervous system pipeline. Axsome stock jumped more than 20% and traded in the low-$180s, marking one of its strongest weekly performances in recent years.

The rally was driven primarily by news that the U.S. Food and Drug Administration granted Priority Review to Axsome’s supplemental New Drug Application for AXS-05 in the treatment of agitation associated with Alzheimer’s disease. As reported by GlobeNewswire, the FDA set a target action date of April 30, 2026, significantly accelerating the regulatory timeline and increasing confidence in a potential label expansion for the company’s lead product.

Market reaction to the FDA decision was swift. Investing*com noted that the Priority Review designation pushed Axsome shares to record levels, reflecting investor optimism around the commercial potential of AXS-05 in a large and underserved patient population. Analysts view the indication as a meaningful revenue opportunity if approved, given the limited treatment options currently available.

Beyond AXS-05, Axsome’s broader pipeline has also supported sentiment. Quiver Quantitative reported that the company remains on track to submit a New Drug Application for AXS-12, a treatment candidate for narcolepsy with cataplexy, in early 2026. This adds another near-term catalyst and reinforces Axsome’s positioning as a focused neuroscience developer.

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Global Finance News 01-01-26

Axsome Therapeutics Reports 72% Surge in Q2 Revenue, Driven by AUVELITY and SUNOSI Growth

Axsome Therapeutics (NASDAQ: AXSM) posted strong second-quarter results, with net product revenue rising 72% year-over-year to $150 million, driven by robust demand for its CNS treatments.

AUVELITY led the gains with Q2 sales of $119.6 million, up 84% year-over-year, while SUNOSI posted $30 million in revenue, up 35%. Newly launched SYMBRAVO, approved for migraines, contributed $0.4 million in its debut quarter.

CEO Herriot Tabuteau highlighted advancing regulatory milestones, including plans to submit new drug applications for AXS-05 in Alzheimer’s agitation (Q3) and AXS-12 for narcolepsy (Q4). Despite a $48 million net loss, down from $79.3 million a year ago, Axsome reaffirmed its cash runway into profitability, with $303 million in reserves as of June 30.

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European Investor 08-05-25

Axsome Shareholders Approve Key Proposals at 2025 Annual Meeting

NEW YORK – June 9, 2025 – Axsome Therapeutics, Inc. (Nasdaq: AXSM) announced the results of its 2025 Annual Meeting of Stockholders held on June 6. Approximately 84% of eligible shares were represented.

Meeting Highlights:

Roger A. Jeffs, Ph.D. was elected as Class I director to serve until the 2028 annual meeting.

Stockholders approved the 2025 Long-Term Incentive Plan.

Deloitte & Touche LLP was ratified as the Company’s independent auditor for fiscal year 2025.

A non-binding vote approved the compensation of the Company’s named executive officers.

All proposals received majority support, reinforcing shareholder confidence in Axsome’s leadership and strategic direction.

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M

ME NEWS 06-10-25

Axsome Therapeutics Secures $570 Million Credit Facility from Blackstone

Axsome Therapeutics (NASDAQ: AXSM) has entered a $570 million term loan and revolving credit agreement with funds managed by Blackstone Life Sciences and Blackstone Credit & Insurance. The deal retires Axsome’s prior term loan with Hercules Capital, significantly reducing the company’s interest expense and expanding its available credit by over $200 million.

The new credit facility includes a $500 million term loan and a $70 million revolving credit line, with $120 million drawn at closing to repay the earlier facility. Axsome may draw an additional $250 million at its discretion, with another $200 million subject to Blackstone approval. Terms include SOFR + 4.75% interest on the term loan and SOFR + 4.0% on the revolving facility, maturing in May 2030 with a 60-month interest-only period. Blackstone also purchased $15 million in Axsome stock at a 30-day VWAP of $107.14.

Axsome CEO Dr. Herriot Tabuteau highlighted the partnership’s role in accelerating profitability while advancing the company’s mission in CNS treatment. Blackstone executives emphasized Axsome’s strong pipeline and commercial execution as key to the investment.

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The Investor 05-13-25

Axsome Posts Strong Q1 Revenue Growth, Advances Late-Stage CNS Pipeline
Financial Highlights:
• Total Q1 2025 net product revenue: $121.5 million (up 62% YoY)
o AUVELITY: $96.2 million (up 80% YoY)
o SUNOSI: $25.2 million (up 17% YoY)
• Net loss: $59.4 million or $(1.22) per share, compared to $(68.4) million or $(1.44) per share in Q1 2024
• Cash and equivalents: $300.9 million as of March 31, 2025
Commercial Performance:
• AUVELITY: 167,000 prescriptions in Q1 2025 (up 76% YoY), 78% payer coverage across channels
• SUNOSI: 46,000 prescriptions (up 12% YoY), 83% payer coverage
Pipeline and Regulatory Updates:
• SYMBRAVO (for acute migraine) approved in January; U.S. commercial launch expected June 2025
• AXS-14 (fibromyalgia): NDA submitted; FDA filing decision expected Q2 2025
• AXS-05 (Alzheimer’s agitation): Supplemental NDA submission on track for Q3 2025
• AXS-12 (narcolepsy): NDA submission planned for 2H 2025
Clinical Trial Milestones:
• Solriamfetol (ADHD): Positive Phase 3 results in adults; pediatric trial planned for 2025
• Solriamfetol (MDD with EDS): Phase 3 trial to start in 2025
• Ongoing Phase 3 trials: Binge eating disorder (ENGAGE) and shift work disorder (SUSTAIN) – topline results expected in 2026
Litigation Update:
• Settlement reached with Hikma on SUNOSI patent litigation; generic entry not expected before 2040

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WS Investor 05-05-25

Axsome Reports Positive Phase 3 Results for Solriamfetol in ADHD Trial

On March 25, 2025, Axsome Therapeutics announced that its Phase 3 FOCUS trial evaluating solriamfetol for the treatment of attention deficit hyperactivity disorder (ADHD) met its primary and key secondary endpoints. The company’s investigational use of solriamfetol, currently approved for other indications, demonstrated significant clinical efficacy in adults with ADHD.

The successful outcome of the FOCUS study marks a major milestone for Axsome’s pipeline, potentially expanding the use of solriamfetol into a new therapeutic area. Full details were shared in a press release attached to the company’s 8-K filing with the SEC.

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WS Investor 03-25-25

Axsome Therapeutics announced that it has reached a settlement agreement with Hikma Pharmaceuticals USA, resolving patent litigation related to Axsome’s drug Sunosi (solriamfetol). The litigation arose from Hikma’s submission of an Abbreviated New Drug Application to the FDA seeking approval to market a generic version of Sunosi. Under the settlement, Axsome will grant Hikma a license to sell its generic version starting on or after March 1, 2040, or September 1, 2040, if pediatric exclusivity is granted. The agreement is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice. Litigation against other parties regarding Sunosi remains ongoing.

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The Investor 03-05-25

Axsome Therapeutics, Inc. announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA), supporting a supplemental NDA submission for AXS-05 in treating agitation associated with Alzheimer’s disease. The company plans to proceed with its submission based on this feedback.

A full press release detailing this development has been filed as an exhibit with the U.S. Securities and Exchange Commission.

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Global Finance News 03-03-25

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