NEW YORK — Axsome Therapeutics Inc. shares jumped more than 13.8 percent to $231.93 in early trading Monday, May 4, 2026, extending gains after the company received U.S. Food and Drug Administration approval for expanded use of its drug AUVELITY to treat agitation associated with Alzheimer's disease and reported solid first-quarter financial results. The biotech company's stock has been on a tear since late April, driven by regulatory success and growing confidence in its central nervous system pipeline.

The FDA approval on April 30 marked a significant milestone for Axsome, positioning AUVELITY as the first non-antipsychotic treatment for Alzheimer's-related agitation. This new indication expands the drug's potential market dramatically, targeting a condition that affects millions of patients and caregivers with limited safe treatment options. Analysts estimate the addressable market for this indication could exceed $2 billion annually at peak sales, providing a major growth driver for the company.

Axsome reported first-quarter revenue of $191.2 million, up 57.4 percent year-over-year, beating analyst expectations. The company also narrowed its net loss while investing heavily in commercial infrastructure and pipeline advancement. Cash reserves remain sufficient to fund operations through key upcoming milestones, including potential label expansions........

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