The Food and Drug Administration could be nearing a decision on Axsome Therapeutics' depression treatment, and AXSM stock rocketed past two key moving averages Monday.
In a Securities and Exchange Commission filing, Axsome said the FDA had provided it with revised proposed labeling for its depression drug, now known as AXS-05.
"We view this announcement as good news and a significant step forward," Mizuho Securities analyst Vamil Divan said in a report to clients. "Label negotiation typically takes place at the end of the review process. As such, the FDA decision on AXS-05 could be imminent."
AXSM stock soared 51.4% to 37.03 on today's stock market. Shares leapt over their 50-day and 200-day moving averages, according to MarketSmith.com.
AXSM Stock: Modulating Glutamate
Axsome's drug interacts with receptors in the brain to modulate a neurotransmitter called glutamate. Current thinking is abnormal levels of glutamate can lead to depression.
This month, Axsome said treatment with AXS-05 significantly reduced depression symptoms in a final-phase study. Anhedonia, the inability to feel pleasure, is present in up to three-quarters of patients with major depressive disorder.
In the study, Axsome's drug led to a "rapid, substantial and statistically significant improvement in symptoms of anhedonia compared with placebo."
At the time, the news sent AXSM stock up more than 3%.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
