Axsome Therapeutics IncDosed first patient in Phase III SUMMIT study for AXS-05 in smoking cessation, advancing pipeline.

Axsome Therapeutics has dosed the first patient in the phase III SUMMIT study evaluating AXS-05 for smoking cessation. The randomized, double-blind, placebo-controlled trial will assess the safety and efficacy of AXS-05 in adult smokers, with participants receiving AXS-05, bupropion, or placebo in a 1:1:1 ratio for about 12 weeks, and the primary endpoint is smoking abstinence at the end of treatment. AXS-05, marketed as Auvelity in the U.S. for major depressive disorder, was approved in April 2026 for agitation associated with Alzheimer's dementia. Auvelity generated $333 million in first-half 2026 sales, up 54.2% year over year, while Sunosi contributed $66.5 million, up 25.5%, and Symbravo added $6.3 million. Year to date, Axsome shares have risen 8.7% versus the industry's 9.7%.
Axsome Therapeutics IncDosed first patient in Phase III SUMMIT study for AXS-05 in smoking cessation, advancing pipeline.
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