Clinical TrialsAXS-05 has shown statistically significant efficacy vs. placebo in three completed pivotal Phase 3 trials, with supportive efficacy and controlled safety results in a fourth trial.
Regulatory ApprovalAXS-05 has been granted Breakthrough Therapy Designation for the treatment of Alzheimer's disease-associated agitation.
Sales PerformanceExpect continued strong performance of Auvelity in MDD, with expansion in sales force and payor access driving significant sales in 2025.