Axsome Therapeutics presented at the 12th Annual Cantor Fitzgerald Global Healthcare Conference on September 10 2026, with CEO Mark Jacobson and CFO Nick Pizie outlining the commercial trajectory of Auvelity and the status of several pipeline assets.
Financially, Auvelity generated $180 million in revenue for the second quarter of 2026, implying an annualized run rate of roughly $720 million. The drug’s share of the major depressive disorder market remains below 0.25 % on a total prescription basis, while new prescription market share stands at 0.42 % (42 basis points). Peak sales estimates exceed $8 billion, split evenly between major depressive disorder and Alzheimer’s disease agitation, with the depression component projected at about $4 billion. Over the prior twelve months, Axsome’s stock price appreciated approximately 70 %.
Market access figures show Auvelity is available to 89 % of covered lives, with government channel coverage at 100 % and commercial channel coverage at 82 %. First‑line or first‑switch coverage applies to north of 55 % to 56 % of those lives. For the Alzheimer’s disease agitation indication, access reaches 100 % of covered lives, more than 85 % of which have no prior‑authorization requirement, and first‑line status is in place across the covered population.
Operationally, the sales force has doubled from 300 to approximately 600 representatives, with average tenure now ranging from four to six months. The proportion of Auvelity prescriptions coming from the 65‑plus Medicare long‑term care cohort rose from 19 % prior to approval to over 30 % of new prescriptions. Baseline market mix for agitation in Alzheimer’s disease is estimated at roughly 60 % community setting and 40 % long‑term care facilities.
Pipeline updates include Solriamfetol (Sunosi), whose ENGAGE Phase III trial in binge eating disorder is slated for top‑line results in the fourth quarter of 2026, with a shift work disorder trial expected in 2027. Additional label expansions are being pursued for major depressive disorder with excessive daytime sleepiness and attention‑deficit/hyperactivity disorder, the latter having completed a positive Phase III adult trial while pediatric studies continue. AXS‑12 (solriamfetol for narcolepsy) carries a PDUFA date of May 1 2027. AXS‑05 has initiated a SUMMIT Phase III trial in smoking cessation, comparing the agent with placebo and bupropion. Other programs noted are AXS‑14 for fibromyalgia (enrollment underway), AXS‑17 for epileptogenesis (tech transfer), and AXS‑20, a PDE10A inhibitor acquired from Takeda in April 2026 for schizophrenia and Tourette syndrome, which is in Phase III‑enabling work after a Phase II study of about 160 patients.
Exclusivity for Auvelity extends through the first quarter of 2039 should a pediatric indication be secured, adding roughly twelve years of protection. Executives emphasized that the commercial foundation is now set and the focus is on execution across sales and pipeline development.
