Why Axsome Is Touching The $100 Level For The First Time In Months

Axsome Therapeutics Inc AXSM, which was a high-flier for most of 2019, has come off the all-time highs reached late last year thanks to the COVID-19 pandemic and a negative readout in late March.

Positive Phase 2/3 data released by the company Monday morning seems to have reignited the rally.

Axsome said AXS-05, its investigational NMDA receptor antagonist, met the primary endpoint in a Phase 2/3 trial dubbed ADVANCE-1 that evaluated the candidate in Alzheimer's disease patients.

AXS-05 rapidly, substantially and significantly improved agitation in patients with Alzheimer's disease compared to placebo, according to the company.

The study was designed such that 366 Alzheimer's patients were randomized to receive AXS-05, bupropion — active comparator — or matching placebo for five weeks. The primary endpoint was a statistically significant reduction in the Cohen Mansfield Agitation Inventory total score.

The clinically significant reductions in agitation were accompanied by a favorable safety and tolerability profile, Axsome said, citing Jeffrey Cummings, Chambers Professor of Brain Science at the University of Nevada Las Vegas.

"Given the lack of approved treatments for Alzheimer's disease agitation, and the safety concerns and modest or uncertain efficacy of currently used off-label treatments, the AXS-05 study results represent a meaningful step forward toward urgently needed treatment for this serious complication of Alzheimer's disease," Cummings said in a statement.

The company said it will submit detailed study results for presentation at upcoming medical meetings and for publication.

Axsome shares were trading 24.25% higher at $94.93 at the time of publication Monday.

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