Axsome Therapeutics (NASDAQ:AXSM) executives said the company is preparing for a June commercial launch of AUVELITY in Alzheimer’s disease agitation following a recent U.S. Food and Drug Administration approval, while also expanding commercial efforts across depression, migraine and sleep-related indications.
Speaking at an investor conference, Chief Operating Officer Mark Jacobson said the company was “very, very happy” with the newly approved label, which he described as “very clean” and differentiated. He said the product’s mechanism targets NMDA and sigma-1, and that the label includes data showing separation from placebo beginning at two weeks, as well as durability of treatment effect based on the ACCORD-2 randomized withdrawal trial.
Launch preparations focus on training and long-term care
AUVELITY is already marketed for major depressive disorder, and Jacobson said the same maintenance dose applies. Ahead of the June launch, he said Axsome is focused on training its sales team, updating visual aids and marketing materials, and continuing payer and long-term care preparation.
Jacobson said there is “high excitement” among physicians and key opinion leaders for a new treatment option in Alzheimer’s disease agitation, citing a market with roughly 21 million prescriptions annually. He said about 99% of those prescriptions have historically been for off-label pharmacotherapies due to the limited number of approved products.
The current prescription split in the market is about 60% in the community setting and 40% in long-term care, Jacobson said. Historically, Axsome’s AUVELITY sales team has focused on the community setting, but the company now plans to engage long-term care facilities. Axsome previously announced an expansion of the AUVELITY sales force to about 630 representatives, with a small percentage exclusively focused on long-term care.
Jacobson said about 80% of community targets overlap across the depression and Alzheimer’s agitation indications. In long-term care, he said there is also significant overlap, with depression present in a large share of residents.
Chief Financial Officer Nick Pizzie added that Axsome has not called on long-term care centers to date and sees potential in major depressive disorder within those facilities as well. He referenced historical long-term care sales for Lexapro in major depressive disorder as a point of comparison, while noting the company’s focus is not limited to Alzheimer’s disease agitation.
Payer access expected to support uptake
Pizzie said Axsome expects at least 80% of Alzheimer’s disease agitation prescriptions to be in Medicare Part D, where the company has 100% covered lives. He said Axsome anticipates that about 75% of those covered lives would not have prior authorization requirements, or would have relatively limited step requirements, while the remaining 25% would likely have prior authorization tied to indication.
“We feel coming out of the gate, with the launch in ADA, access is fairly accessible,” Pizzie said.
Jacobson said the payer profile means that, in most cases, prescriptions that are written “should be filled.” Pizzie contrasted the current situation with AUVELITY’s 2022 launch in major depressive disorder, when payer access was more limited. He said AUVELITY now has 86% total covered lives.
Asked about competition from the branded antipsychotic Rexulti, Jacobson said that launch has been informative but distinct. He said Axsome sees the market as large enough for multiple products and will focus on education around AUVELITY’s profile and appropriate patients.
Major depressive disorder remains a growth focus
Pizzie said Axsome is also looking to expand AUVELITY use in major depressive disorder, particularly in primary care, as the sales force grows from roughly 300 representatives to 630. He said AUVELITY currently represents about 22 basis points of the total antidepressant market, up from 0.15% at the beginning of 2025.
He said the company has made limited investments in marketing and advertising to date, though it tested direct-to-consumer advertising in the fourth quarter and plans to refine that approach. Pizzie also cited improved payer access, including 70% commercial covered lives, 86% total covered lives and 100% coverage in the government channel.
Jacobson said about one-third of AUVELITY prescriptions are currently written by primary care providers, despite the company’s historically lean sales effort. He said expanded access, multiple indications and increased sales investment are expected to support continued growth.
Updates on SYMBRAVO, Sunosi and pipeline programs
Axsome also discussed SYMBRAVO, its migraine product. Pizzie said prescriptions grew 36% quarter over quarter from the fourth quarter to the first quarter, and payer coverage has increased to roughly 57% of covered lives. He said the company is expanding the SYMBRAVO sales team from 100 to 150 representatives as access improves.
Jacobson said clinician feedback has indicated that SYMBRAVO’s real-world use is matching the clinical data, particularly around efficacy, which he described as the key unmet need cited by migraine patients and providers.
In sleep medicine, Jacobson said Sunosi is marketed for excessive daytime sleepiness in obstructive sleep apnea and narcolepsy. Axsome has also submitted a new drug application for AXS-12 in cataplexy in narcolepsy, with an FDA acceptance decision expected as the next update. If approved, he said AXS-12 would fit into the company’s existing sleep commercial infrastructure.
Jacobson also highlighted ongoing development work for Sunosi, including programs in binge eating disorder, ADHD, shift work and major depressive disorder in patients with excessive daytime sleepiness symptoms. He said a Phase III binge eating disorder trial is ongoing, with a readout expected later this year, and that a positive study would lead to additional work previously aligned with the FDA.
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.
