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 ...

Axsome Therapeutics AXSM announced that it has received formal feedback from the FDA on its plans to seek approval for AXS-05 ...

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 ...

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 ...

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 ...

Despite Auvelity's revenue growth ... that are notoriously difficult for drugs to prove safe and effective (high placebo rates, subjective patient-reported outcomes) in clinical trials ...

The drug could have significant commercial potential ... Axsome plans to file for FDA approvals of AXS-05 (Auvelity) in treating Alzheimer's disease and AXS-12 in treating narcolepsy in 2025.

Auvelity recorded sales of $92.6 million, up 89% year over year. Sales of the drug beat our model estimate of $87.7 million. Per Axsome, around 158,000 prescriptions were recorded for Auvelity in ...

Axsome will grant Teva a license to sell its generic version of Auvelity beginning on or after March 31, 2039, if pediatric exclusivity is granted, or on or after Sept. 30, 2038, if no pediatric ...