Axsome Therapeutics (AXSM) Advances To Cross $100-Mark

(RTTNews) - Axsome Therapeutics Inc.'s (AXSM) phase II/III trial of investigational drug AXS-05 in Alzheimer's disease agitation has met the primary endpoint.

Alzheimer's disease is the most common form of dementia and is characterized by cognitive decline and behavioral and psychological symptoms including agitation. Agitation is observed in up to 70% of patients with Alzheimer's disease and is associated with accelerated cognitive decline, earlier nursing home placement, and increased mortality risk, the Company noted.

In the trial, dubbed ADVANCE-1, there was a statistically significant improvement in Alzheimer's disease agitation, as measured by the CMAI total score, in patients treated with AXS-05 compared to placebo.

There are currently no FDA-approved treatments for Alzheimer's disease agitation.

Earlier, AXS-05 has also demonstrated efficacy in depression and smoking cessation trials.

The Company remains on track to submit an NDA for AXS-05 for the treatment of major depressive disorder, as well as for its AXS-07 product candidate for the acute treatment of migraine, both in the fourth quarter of this year.

AXSM closed Friday's trading at $76.40, up 7.32%. In pre-market trading on Monday, the stock is up 37.43% to $105.