Through development of therapeutic options with novel mechanisms of action, the US company is transforming the approach to treating CNS conditions.

Axsome’s bid to market its option in Alzheimer’s disease, an area which has gained renewed interest thanks to the recent launch of novel therapeutics for the first time in decades, comes after US approval was granted in major depressive disorder (MDD) in 2022. Marketed as Auvelity, the drug is forecast by some analysts to have blockbuster potential.

In its annual results statement, the company revealed that the US FDA had advised that more safety data, including from the ongoing ADVANCE-2 trial, would be required. Based on current enrollment trends, the company said it would now try to complete the ADVANCE-2 trial in the first half of 2024, earlier than the previous estimate of mid-2025.