AXSM stock jumps after FDA sets April 30 decision date for Axsome’s AXS-05 in Alzheimer’s agitation

Axsome Therapeutics shares jumped 22.9% in the Dec. 31 session, ending at $182.64 after the company disclosed two U.S. FDA updates that put near-term regulatory milestones back in focus. The stock traded between $148.79 and $184.40 on the day, with about 3.1 million shares changing hands.

NASDAQ:AXSM · Pharmaceuticals
Axsome Therapeutics (AXSM) stock jumps after FDA sets April 30 decision for Alzheimer’s agitation drug

Axsome Therapeutics (AXSM) stock jumps after FDA sets April 30 decision for Alzheimer’s agitation drug

Axsome Therapeutics shares jumped about 23% in the most recent session on Wednesday after the company said the U.S. Food and Drug Administration accepted its supplemental application for AXS-05 to treat agitation in Alzheimer’s disease and granted the filing priority review. The stock last traded at $182.64, after swinging between $148.79 and $184.40 on volume of about 3.1 million shares. Businessinsider
1 January 2026
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Axsome stock jumps 23% after FDA sets April 30 deadline for Alzheimer’s agitation review

Axsome stock jumps 23% after FDA sets April 30 deadline for Alzheimer’s agitation review

Axsome Therapeutics Inc shares jumped 22.9% to $182.64 in Wednesday’s session, after touching $184.40, with about 3.1 million shares traded. The CNS drugmaker said the U.S. Food and Drug Administration accepted and granted priority review to its supplemental new drug application for AXS-05 — marketed as Auvelity for major depressive disorder — for agitation in Alzheimer’s disease, setting an April 30 action date. “Up to 76% of people with Alzheimer’s disease experience agitation, representing a significant unmet medical need,” Chief Executive Herriot Tabuteau said. GlobeNewswire
1 January 2026
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Axsome stock jumps nearly 23% after FDA fast-tracks AXS-05 for Alzheimer’s agitation

Axsome stock jumps nearly 23% after FDA fast-tracks AXS-05 for Alzheimer’s agitation

Axsome Therapeutics, Inc. shares jumped 22.9% to $182.64 in after-hours trading on Wednesday after the company said the U.S. Food and Drug Administration accepted its supplemental New Drug Application for AXS-05 to treat agitation linked to Alzheimer’s disease and granted it Priority Review. The agency set an April 30, 2026 target action date, and CEO Herriot Tabuteau said “up to 76% of people with Alzheimer’s disease experience agitation.” GlobeNewswire
1 January 2026
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Axsome Therapeutics (AXSM) Skyrockets on CNS Breakthroughs: Stock Surge, Pipeline Wins, and 2025 Outlook

Axsome Therapeutics (AXSM) Skyrockets on CNS Breakthroughs: Stock Surge, Pipeline Wins, and 2025 Outlook

Axsome’s stock has been a standout performer in 2025. As of November 3, 2025, AXSM trades around $134–$135 per share, roughly doubling from its 52-week low of $75.56 Finviz. The stock has gained about 60% year-to-date and 52% over the past year Seattlepi – a remarkable run that far outpaces the broader biotech sector and the S&P 500. This surge reflects growing investor optimism as Axsome transforms into a commercial-stage company with multiple marketed drugs.
3 November 2025
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