Fresh off gaining an FDA expansion for Auvelity as a treatment for Alzheimer’s disease agitation (ADA), Axsome Therapeutics has projected peak sales for the non-antipsychotic drug to reach $8 billion.
The New York City biotech sees a 50-50 split of revenue between Auvelity’s two indications. It was originally approved in 2022 to treat major depressive disorder (MDD).
The $8 billion guidance is up from Axsome’s previous projection of between $2.5 billion and $6 billion. The company revealed (PDF) its new estimate Monday along its first-quarter financial results.
Since gaining the ADA nod on Thursday, Axsome’s share price has increased by 23%, with similar-sized jumps triggered by the approval and the company’s new expectations for Auvelity.
During a conference call on Monday, Axsome’s chief commercial officer, Ari Maizel, pointed out that 76% of the seven million patients who have Alzheimer’s disease are impacted by agitation symptoms and that there is just one other approved treatment on the market for the disorder—Lundbeck and Otsuka’s Rexulti.
“When we review our proprietary market research on HCP perceptions, potential use of the product, taken together with the clarity around the final label, it really provides confidence that Auvelity will be used as a frontline treatment in Alzheimer's agitation, and we've seen growing uses [in] frontline treatment and MDD,” Maizel said.
In response to Axsome’s new estimate, Mizuho Securities bumped its peak revenue projection for Auvelity from $3.2 billion to $5 billion, with $2.6 billion in MDD and $2.4 billion in ADA. Mizuho’s previous breakdown was $2 billion in MDD and $1.2 billion in ADA.
“We believe there already existed decent investor skepticism regarding Axsome being able to achieve the prior $6 billion top-end guidance range estimate. Thus, at $8 billion, skepticism likely increases further,” Mizuho analyst Graig Suvannavejh, Ph.D., wrote in a note to investors.
Suvannavejh added that in his discussions with investors, they suggested that with the high level of biopharma M&A activity this year, the updated guidance was “subtle (or maybe not so subtle) messaging of Axsome’s potential future strategic goals.”
Mizuho added that even with Axosome's stock up 45% over the past three weeks, it still finds the company “incredibly attractive at current levels.”
Analysts at Leerink Partners were also surprised by Axsome’s “bold peak sales guidance.”
“We certainly see $2 billion per indication as realistic, but management is even more confident given the planned increase in sales force, marketing spend and contracting as well as the slow and steady move upwards in the MDD treatment paradigm,” Leerink wrote.
Axsome said it is increasing its sales force to 630 reps, targeting 68,000 healthcare professionals. The company plans to launch Auvelity in its ADA indication next month.
As for the first quarter, Auvelity sales reached $153 million, which were up 59% year-over-year but down sequentially from $155 million in the fourth quarter of last year.
Axsome has fared well in its competition with Lundbeck and Otsuka, with Auvelity generating sales of $507 million last year, up 74%. Meanwhile, Lundbeck reported 2025 sales of Rexulti at 6.21 billion Danish kroner ($973 million), which were up by 23%.
Both are oral medications, with Auvelity becoming the first non-antipsychotic option for ADA. Another point of differentiation—and one which favors Auvelity—is that Rexulti carries a black box warning for posing a higher risk of mortality for those with dementia-related psychosis.
The next step for Axsome in its development of Auvelity is setting up a pivotal trial for smoking cessation. The company is also investigating Auvelity’s potential to treat other central nervous system indications, according to chief operating officer Mark Jacobson.
“The product is very interesting given that it targets NMDA and sigma-1 receptors, with high potential applicability to other neuropsychiatric conditions and that's something that the team is obviously exploring,” Jacobson said.