On the last day of the year, shares of Axsome Therapeutics Inc. rose 22% on news that the U.S. FDA accepted and granted priority review of the company’s supplemental NDA for AXS-05 to treat Alzheimer’s disease agitation, a $1 billion-plus opportunity, scheduling the PDUFA date for April 30.
Axsome Therapeutics Inc.’s AXS-05 (dextromethorphan + bupropion) has notched another success by hitting its phase III primary endpoint in treating a notoriously difficult Alzheimer’s disease (AD) indication when compared to placebo. Newly released data from the Accord study showed AXS-05, an oral, NMDA receptor antagonist with multimodal activity, statistically significantly delayed time to relapse of AD agitation vs. placebo (p=0.014), which was the primary endpoint.
A year from the U.S. FDA’s August 2021 citation of deficiencies in the labeling for Axsome Therapeutics Inc.’s major depressive disorder therapy, Auvelity (dextromethorphan + bupropion), the agency has approved the drug for use by adults. The New York-based company’s stock (NASDAQ:AXSM) took flight on the news, with shares rising 40% to close at $59.55 Aug. 19, surpassing their previous 52-week high of $48.82 and starkly contrasting with a same-period low of $19.38.
