Axsome Begins Phase III Study on AXS-05 for Smoking Cessation

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 compare AXS-05 against bupropion and placebo over 12 weeks, with smoking abstinence as the primary endpoint. Axsome's lead drug Auvelity continues to drive strong revenue growth, generating $333 million in H1 2026 (up 54.2% YoY), while the company's diversified portfolio includes Sunosi and newly launched Symbravo.