Why Axsome Shares Are Pulling Back After A Clinical Readout

Shares of Axsome Therapeutics Inc AXSM — which skyrocketed 3,565% in 2019 thanks to a steady stream of positive clinical updates — were tanking Monday.

Axsome's Mixed Results Trigger Investor Pullback

In a late-stage clinical readout, New York-based Axsome said AXS-05, its Phase 3 asset that is being evaluated for treatment-resistant depression, did not achieve the primary endpoint of statistically significant numerical improvement in the Montgomery-Asberg Depression Rating Scale, or MADRS at week six. 

AXS-05 showed mean reductions of 11.6 compared to 9.4 for the active comparator bupropion, according to the company. 

AXS-05 is an oral investigational NMDA receptor antagonist with multimodal activity.

The Phase 3 study dubbed STRIDE-1 was a double-blind, active-controlled, multicenter U.S. trial that evaluated 312 adult patients with confirmed TRD who had failed two or three prior treatments and were randomized to received either AXS-05 or 150mg of bupropion twice daily for six weeks.

The investigational candidate met key secondary endpoints: statistically significant improvement in symptoms of depression as early as Week 1, and for the six-week treatment week, improvement in cognitive functions and reduction in anxiety symptoms.

AXS-05 was well tolerated, with dizziness and nausea being the commonly reported adverse events and low rates of discontinuation due to adverse events, according to Axsome. 

What's Next For Axsome 

Axsome said it intends to initiate a second Phase 3 trial of AXS-05 in patients with TRD in the third quarter of 2020. The company also said it plans to submit detailed study results for presentation at upcoming medical meetings and for publication.

The company said it remains on track to file an NDA in the fourth quarter for AXS-05 in the treatment of major depressive disorder, based on the previously completed positive GEMINI and ASCEND trials.

Axsome said results from the INTERCEPT Phase 3 trial of AXS-07 in the early treatment of migraine are imminent, while data from the ADVANCE-1 Phase 2/3 trial of AXS-05 in Alzheimer's disease agitation is expected in early second quarter.

AXSM Price Action

The stock was down 11.53% at $55.98 at the time of publication Monday.