Axsome (AXSM) Banks on Auvelity & Sunosi to Fuel Growth

Core Insights - Axsome Therapeutics' first marketed drug, Auvelity, launched in the U.S. in 2022 for major depressive disorder, generated $118.4 million in sales in the first half of 2024, reflecting a 172.8% year-over-year increase due to strong demand [1] - The company is conducting label expansion studies for Auvelity targeting other CNS disorders, including agitation associated with Alzheimer's disease, with topline data expected in the second half of 2024 [1] - Axsome plans to initiate a phase II/III pivotal study for AXS-05 for smoking cessation later in 2024, which could broaden the drug's patient population and drive further sales [2] Product Portfolio - Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals in May 2022, which targets narcolepsy and generated $42.2 million in net product sales in the first half of 2024, a 35.2% year-over-year increase [2] - The licensing agreement with Pharmanovia allows Axsome to market Sunosi in Europe and certain Middle East/North African countries, earning royalties on sales in those territories [3] - The company has a pipeline of candidates, including AXS-07 for acute migraine treatment, with an NDA resubmission to the FDA expected in the second quarter of 2024 [3] Competitive Landscape - Despite the success of Auvelity and Sunosi, competition is increasing in the CNS disorder treatment market, with companies like Acadia Pharmaceuticals developing treatments such as Nuplazid for various CNS indications [4]