-- Axsome Therapeutics (AXSM) could see meaningful upside ahead of a US Food and Drug Administration decision on Auvelity for agitation associated with Alzheimer's disease, which has a high likelihood of approval and could add about $2 billion in incremental sales, UBS Securities said in a note Friday.
The FDA has set an April 30 Prescription Drug User Fee Act date for Auvelity's Alzheimer's agitation filing, with analysts at the firm saying a decision could come earlier and that the drug is unlikely to carry an added mortality boxed warning given its "antidepressant" classification and lack of supporting "safety signals," though its existing suicidality warning is expected to remain, according to the report.
The firm said Axsome shares could move about 12% higher or 18% lower on the decision depending on label outcomes.
Analysts cut Q1 2026 Auvelity sales estimates to $149 million from $160 million on seasonal headwinds and flat prescriptions, but maintained a positive full-year outlook with 2026 sales seen at $793 million, supported by a larger sales force and wider coverage, with potential contribution from the Alzheimer's indication starting in the third quarter if approved.
UBS has a buy rating on Axsome Therapeutics and raised its price target to $259 from $251.
Price: $179.10, Change: $+0.20, Percent Change: +0.11%