FDA Approves AUVELITY — Axsome Therapeutics, Inc.

# FDA Approves Axsome Therapeutics' AUVELITY for Major Depressive Disorder Axsome Therapeutics received FDA approval for AUVELITY (dextromethorphan hydrobromide/bupropion hydrochloride), a novel oral combination therapy that could capture significant market share in the multibillion-dollar depression treatment market by offering patients a new mechanism of action. The approval represents a key value driver for Axsome and positions the company to compete against established antidepressants while addressing the substantial unmet need among patients with treatment-resistant depression.