Shares of Axsome Therapeutics (AXSM) were up about 32% on a volume spike to 10.65 million shares, as compared to daily average volume of 1.28 million shares.

All after the company’s “AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the primary and key secondary endpoints in the ACCORD (Assessing Clinical Outcomes in Alzheimer’s Disease Agitation) Phase 3 trial, by substantially and statistically significantly delaying the time to relapse and preventing relapse of agitation in patients with Alzheimer’s disease, as compared to placebo.”

Unfortunately, agitation is one of the most troubling parts of the disease for patients, and can potentially lead to nursing home placement, accelerated cognitive decline, and increased rates of mortality. In addition, it’s an unmet medical need with no approved treatments so far.  That could soon change if AXSM’s treatment is approved.

Herriot Tabuteau, MD, CEO of Axsome added, “With the positive results from ACCORD, AXS-05 has now demonstrated efficacy in the treatment of Alzheimer’s disease agitation in two well-controlled trials. In addition to the strong results versus placebo in the double-blind period, results from the open-label period evidenced rapid, substantial, and significant improvements in Alzheimer’s disease agitation versus baseline with AXS-05 treatment.”

“The ACCORD results complement and are consistent with, those from the previously completed positive ADVANCE-1 trial. We intend to discuss these findings with the FDA in the context of the ongoing clinical development of AXS-05 in this indication, with the goal of providing much-needed treatment to the millions of patients living with Alzheimer’s disease agitation and their caregivers.”

In short, we could be looking at a blockbuster opportunity here and further upside for AXSM.