Axsome reports third-quarter 2026 results, starts Phase 3 smoking cessation trial

Axsome Therapeutics said in August 2026 it initiated the SUMMIT study, a Phase 3 trial testing AXS-05 (dextromethorphan-bupropion) for smoking cessation, using a randomized, double-blind design with both active and placebo controls across multiple centers.¹ The company said it expects topline results from SUMMIT in the second half of 2027.¹

Elsewhere in the pipeline, Axsome said its NDA for AXS-12 (reboxetine) for cataplexy in narcolepsy is under FDA review, with a PDUFA target action date of May 1, 2027.¹ For solriamfetol, the company said the Phase 3 ENGAGE trial in binge eating disorder has reached target enrollment, with topline results expected in the first quarter of 2027.¹ Two other solriamfetol studies, FOCUS-2 and FOCUS-3 in ADHD, and the SUSTAIN trial in shift work disorder, are expected to read out in the second half of 2027.¹ For AXS-20 (balipodect), Axsome said it plans to start a pivotal Phase 3 trial in schizophrenia during the first half of 2027.¹

On financials, Axsome reported total net product revenue of $259.7 million for the third quarter, up 52% from $171.0 million a year earlier.¹ AUVELITY sales were $207.6 million, up 53% from $136.1 million in the prior-year quarter.¹ Net loss was $12.9 million, or $(0.25) per share, compared with a $47.2 million loss a year earlier.¹

On cash, the company said cash and cash equivalents were $313.9 million as of September 30, 2026, down from $322.9 million at the end of 2025.¹ Axsome said it believes current cash is sufficient to fund operations into cash flow positivity under its current operating plan.¹