Axsome Therapeutics Readies Auvelity Alzheimer’s Agitation Launch, Expands CNS Pipeline

Key Points

• Axsome Therapeutics said it is on track to launch Auvelity for Alzheimer’s disease agitation this month, adding a fourth indication to its commercial portfolio. Management said the launch will lean on existing product availability, sales-force training and marketing rather than a brand-new rollout.
• The company is also pushing Auvelity’s growth in major depressive disorder, where management cited a roughly $600 million current run rate and raised peak sales guidance to $8 billion. Axsome has expanded its Auvelity sales force from about 300 to 630 representatives and sees improved coverage and prescription momentum.
• Beyond Auvelity, Axsome highlighted a broad CNS pipeline, including new studies for smoking cessation and multiple Phase 3 programs for Sunosi in ADHD, shift work disorder, binge eating disorder and depression with excessive sleepiness. It also has an NDA pending for AXS-12 in narcolepsy/cataplexy and continues work on additional candidates in epilepsy and schizophrenia.

Axsome Therapeutics NASDAQ: AXSM executives said the company is preparing to launch Auvelity in Alzheimer’s disease agitation this month while continuing to expand the drug’s use in major depressive disorder and advance a broad central nervous system pipeline.

Speaking at a Jefferies fireside chat, Chief Operating Officer Mark Jacobson said Axsome now has three commercial products approved for four indications: Auvelity for major depressive disorder and Alzheimer’s disease agitation, Sunosi for excessive daytime sleepiness in narcolepsy or obstructive sleep apnea, and SYMBRAVO for the acute treatment of migraine in adults.

Jacobson said the company’s near-term commercial focus is the Alzheimer’s disease agitation launch for Auvelity, along with continued growth in major depressive disorder, Sunosi and SYMBRAVO. He said Axsome’s pipeline includes six product candidates across 10 indications in psychiatry and neurology.

Auvelity Launch Expands Into Alzheimer’s Disease Agitation

Jacobson said the Alzheimer’s disease agitation launch is “on track” for this month. Because Auvelity is already available, he said the launch primarily involves completing training, initiating sales-force detailing and educational efforts, and deploying marketing materials.

Axsome recently raised its peak sales guidance for Auvelity to $8 billion. Chief Financial Officer Nick Pizzie said the estimate incorporates potential Medicare drug price negotiation under the Inflation Reduction Act, which he said could affect Auvelity in 2031 or 2032.

Pizzie said Axsome’s current capital deployment is focused on driving top-line revenue growth, particularly through the sales force. He said the company has expanded its Auvelity team from roughly 300 representatives to about 630.

Jacobson highlighted Auvelity’s label in Alzheimer’s disease agitation, citing data showing separation from placebo beginning at week two in a parallel group trial and durable efficacy in a randomized withdrawal study. He said the label includes no boxed warning for the patient population and described the most common adverse reactions as dizziness and dyspepsia.

Jacobson said there are more than 20 million prescriptions written in the Alzheimer’s disease agitation setting, with more than 95% of current use off label. He said Axsome views Auvelity as a potential first-line therapy based on discussions with key opinion leaders and the product’s access position.

Management Points to Market Access and Sales Expansion

In major depressive disorder, Jacobson said Auvelity’s current run rate is about $600 million. Pizzie said Axsome has achieved that with a relatively small historical field force, minimal mass-media direct-to-consumer advertising and improving market access.

Pizzie said Auvelity has 86% covered lives, with 56% first-line or first-switch coverage. He said Auvelity represented about 22 basis points of the total antidepressant market at the end of the first quarter, up more than 50% from the prior-year period. New-to-brand prescription share was about 30 to 32 basis points, which he called a leading indicator.

Pizzie also said approval in Alzheimer’s disease agitation opens long-term care facilities as a new commercial segment, including patients with depression in that setting. He said Axsome had previously avoided calling on long-term care facilities to reduce the risk of off-label promotion.

On gross-to-net pricing, Pizzie said the company started the first quarter in the low 50% range, improved from the mid-50% range a year earlier. He said Axsome ended the fourth quarter of 2025 in the upper 40% range and expects a similar improvement trajectory in 2026 versus 2025. For Alzheimer’s disease agitation, he said at least 80% of patients are expected to be covered by Medicare Part D, which could further improve gross-to-net.

Long-Term Care Seen as Important, but Potentially Gradual

Jacobson said current Alzheimer’s disease agitation prescription trends are roughly 60% in community settings and 40% in long-term care, with primary care accounting for about 35% of prescriptions. Pizzie said 75% of Alzheimer’s disease agitation patients are expected not to require prior authorization, which he said is important for primary care adoption.

Management cautioned that long-term care adoption may not follow the same pattern as community prescribing. Jacobson said facilities often make product decisions across multiple stakeholders, including pharmacy, directors of nursing and prescribers, which can take time. He said Axsome typically expects meaningful impact from a sales force expansion one to two quarters after completion and expects to see impact in the second half of the year.

Pizzie said early signs from the field force expansion have been positive, with new-to-brand prescriptions rising almost 20% over recent weeks, from about 2,700 per week to roughly 3,200 per week.

Pipeline Updates Include Smoking Cessation, Sleep and Psychiatry

Jacobson said Axsome plans to start a study of Auvelity’s development compound, AXS-05, in smoking cessation in the second quarter. He said the rationale includes unmet need, mechanistic relevance and supporting clinical and nonclinical evidence.

For solriamfetol, marketed as Sunosi, Jacobson said Axsome is pursuing four additional indications in active Phase 3 development:

• Attention deficit hyperactivity disorder, with two Phase 3 trials in children and adolescents expected to start this quarter after a positive adult study.
• Major depressive disorder in patients with excessive sleepiness, with a study underway.
• Shift work disorder, with topline data expected next year.
• Binge eating disorder, with Phase 3 topline results expected later this year.

For binge eating disorder, Jacobson said Axsome is looking for a positive study and would expect to run a second study before moving forward. For shift work disorder, he said the company expects only one positive study would be needed for a potential submission, based on FDA feedback that the indication is related to Sunosi’s currently approved indications.

Jacobson said Axsome has submitted a new drug application for AXS-12 in narcolepsy, specifically cataplexy in narcolepsy, and expects to announce the FDA’s acceptance decision this year. If approved, he said AXS-12 would be complementary to Sunosi and synergistic with Axsome’s existing sleep commercial infrastructure. Pizzie said adding AXS-12 to the existing sleep sales team would require little additional operating expense beyond limited marketing costs.

Jacobson also said Axsome continues to enroll a Phase 3 trial for AXS-14 and is conducting trial-enabling work and tech transfer for two newer candidates, AXS-17 for epilepsy and AXS-20 for schizophrenia.

About Axsome Therapeutics NASDAQ: AXSM

Axsome Therapeutics, Inc is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for central nervous system (CNS) disorders. The company focuses on small-molecule drugs designed to address unmet medical needs in areas such as depression, migraine, narcolepsy and fibromyalgia. Axsome employs a precision medicine approach, leveraging pharmacologic innovation to target underlying mechanisms of disease and improve patient outcomes.

Axsome's pipeline includes several late-stage and approved product candidates.

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