Axsome Therapeutics’ AXSM Auvelity (AXS-05) was launched in the United States in 2022 for the treatment of major depressive disorder (MDD), making it the first approved drug in the company’s portfolio ...

Like most other drugs, Auvelity can cause side effects. Hair loss was not reported in the drug’s studies, but it has been reported since the drug was made available on the market. Auvelity can ...

Based on the FDA's feedback, Axsome plans to submit a supplemental NDA for AXS-05 in Alzheimer's disease agitation in third-quarter 2025.

Auvelity is the biggest product in Axsome’s portfolio. Since its commercial launch in the United States in 2022, the drug has played an instrumental role in driving the company’s top line in ...

Auvelity is the first drug Axsome has taken through to regulatory approval, but could be the first of a string of new products for the company, according to Tabuteau. Next up is AXS-07 (meloxicam ...

AUVELITY has demonstrated impressive uptake ... fourth quarter of 2024 and could potentially lead to a supplemental New Drug Application (sNDA) filing in the first half of 2025.

With a strong commercial foundation in AUVELITY and potential near-term catalysts from its pipeline, the company is well-positioned for growth. However, investors should remain cognizant of the risks ...

Axsome Therapeutics' Q4 revenue surged to $118.77 million, surpassing expectations with significant growth in Auvelity sales. Axsome reports progress on multiple drug applications, including ...