William Blair initiated coverage of Axsome Therapeutics (NASDAQ:AXSM) with an “outperform” rating and a fair value estimate of $48. The stock closed at $28.21 on Sept. 17.
Axsome Therapeutics is focused on developing novel therapies for treatment of central nervous system disorders that leverage well-characterized mechanisms of action.
The company currently has four CNS pipeline assets, with three in later-stage clinical development. Lead asset, AXS-05, is a combination therapy of dextromethorphan and bupropion, providing a multimodal mechanism of action, with known efficacy in mood disorders, writes analyst Myles Minter.
After successful completion of the Phase 2 ASCEND trial in patients with major depressive disorder (MDD), Mr. Minter said Axsome expects top-line data from the ongoing Phase 3 GEMINI trial in MDD and Phase 3 STRIDE-1 trial in treatment-resistant depression during the second half of 2019.
“Positive data from either study would be sufficient, alongside the ASCEND trial and open-label safety data, for an NDA filing,” he added.
Beyond depression, Mr. Minter said AXS-05 is being developed in Alzheimer’s disease agitation, with the Phase 2/3 ADVANCE trial expected to read out in first half 2020 after completing an internal futility analysis.
