Shares of Axsome Therapeutics dropped Monday on mixed test results for its Alzheimer's disease agitation treatment.
Agitation is a common symptom of Alzheimer's disease which can cause a patient to feel restless, worried and unable to settle down. In one study comparing Axsome's AXS-05 to a placebo, patients showed a 3.6-fold lower risk of relapsing into agitation.
But a second five-week study didn't pass muster. Axsome Therapeutics' drug led to a 13.8-point improvement in symptoms as measured by a 203-point scale called the Cohen-Mansfield Agitation Inventory, or CMAI. The placebo group had a similar 12.6-point improvement.
Axsome stock skidded 2.2% to close at 84.78. Shares were already below their 50-day line, but made a definitive drop below their 200-day moving average at the open. Shares later retook that key mark.
Axsome Angles For Approval
Still, Axsome Therapeutics is planning to ask the Food and Drug Administration to approve AXS-05 for Alzheimer's disease agitation.
"We believe this data should be adequate for an approvable regulatory package as (management) has indicated previously that all they need beyond (studies called) ADVANCE-1 and ACCORD-1 was safety data set, which we have now," Needham analyst Ami Fadia said in a report.
Investors dinged Axsome stock, though. The successful study, called ACCORD-2, used real-world data while the failed study, ADVANCE-2, compared the drug to a placebo over a shorter time span. The latter is considered "more robust," she said.
Still, Fadia kept her buy rating on Axsome Therapeutics stock.
Follow Allison Gatlin on X, the platform formerly known as Twitter, at @IBD_AGatlin.
