Axsome reports 2Q 2026 results, Alzheimer's agitation launch, AXS-12 NDA accepted
FDA accepted the AXS-12 narcolepsy NDA with a May 1, 2027 PDUFA date as two solriamfetol ADHD trials began.
Axsome Therapeutics reported second quarter 2026 results on August 10, 2026, alongside a series of regulatory and clinical updates across its pipeline.
Axsome launched AUVELITY in Alzheimer's disease agitation in June 2026.1 New-to-brand prescriptions among patients 65 and older increased 126% during the first eight weeks following that launch compared to the prior quarter.1
On the regulatory side, Axsome's NDA submission for AXS-12 for the treatment of cataplexy in narcolepsy was accepted by the FDA and assigned a PDUFA target action date of May 1, 2027.1 AXS-12 has been granted FDA Orphan Drug designation for narcolepsy.1
In the ADHD program, in June and July 2026, Axsome initiated the FOCUS-3 and FOCUS-2 Phase 3, randomized, double-blind, placebo-controlled, multicenter trials evaluating solriamfetol as a treatment for adolescents and children with ADHD, respectively.1 The primary endpoint in both studies is the change from baseline to week 6 in the ADHD Rating Scale (ADHD-RS-5) total score.1
Other solriamfetol programs continue: Axsome anticipates topline results from the ENGAGE Phase 3 trial in binge eating disorder in the fourth quarter of 2026,1 and topline results from the SUSTAIN Phase 3 trial in shift work disorder are anticipated in 2027.1 Axsome is on track to initiate a pivotal Phase 2/3 trial of AXS-05 in smoking cessation in the third quarter of 2026.1
On finances, cash and cash equivalents totaled $319.9 million at June 30, 2026, compared to $322.9 million at December 31, 2025.1 Axsome said its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.