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NASDAQ:AXSM News 3 November 2025 - 2 January 2026

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

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

NEW YORK, January 1, 2026, 21:06 ET — Market closed 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. The move matters because the FDA set a firm target date for a decision on Axsome’s bid to expand AXS-05 into Alzheimer’s disease agitation, a label expansion that investors view as a step-change opportunity for revenue. The agency’s clock also compresses uncertainty: traders often
2 January 2026
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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

NEW YORK, January 1, 2026, 16:58 ET — Market closed 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 Why it matters now: priority review shortens the FDA’s review target to six months, versus 10 months under the standard process, pulling a key binary catalyst into the first
1 January 2026
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Healthcare stocks today: FDA decisions jolt biotechs as Wall Street shuts for New Year

Healthcare stocks today: FDA decisions jolt biotechs as Wall Street shuts for New Year

NEW YORK, January 1, 2026, 13:41 ET — Market closed Vanda Pharmaceuticals’ FDA win in motion sickness set the tone for outsized, stock-specific swings in healthcare shares as Wall Street paused for the New Year’s Day holiday. U.S. stock markets were closed Thursday. Nasdaq The moves matter because regulatory calls can dominate small-cap biotech even when the broader healthcare sector trades like a defensive corner of the market. Investors also head into January watching how rates and earnings guidance reshape valuations after thin year-end trading. In Wednesday’s final session of 2025, the Health Care Select Sector SPDR Fund (XLV) fell
1 January 2026
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Axsome (AXSM) stock jumps after FDA sets April decision date for Alzheimer’s agitation filing

Axsome (AXSM) stock jumps after FDA sets April decision date for Alzheimer’s agitation filing

NEW YORK, January 1, 2026, 07:18 ET — Market closed Key points: With U.S. markets closed on Thursday for the New Year’s Day holiday, Axsome Therapeutics shares were last up 22.9% at $182.64 after the company said the FDA granted priority review for its Alzheimer’s disease agitation filing. The stock swung between $148.79 and $184.40 in Wednesday’s session. Volume was about 3.1 million shares. Axsome said the FDA accepted for filing its supplemental new drug application (sNDA) for AXS-05 in Alzheimer’s disease agitation and granted Priority Review, which shortens the agency’s target review time to about six months. The FDA
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

NEW YORK, January 1, 2026, 03:20 ET — Market closed 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 (dextromethorphan-bupropion) — 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 The priority review gives
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

NEW YORK, December 31, 2025, 19:19 ET — After-hours 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 The decision matters because Priority Review shortens the FDA’s review timeline, pulling a key regulatory catalyst forward for investors who have been
1 January 2026
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Axsome Therapeutics (AXSM) stock jumps 23% after FDA priority review for Alzheimer’s agitation filing

Axsome Therapeutics (AXSM) stock jumps 23% after FDA priority review for Alzheimer’s agitation filing

NEW YORK, December 31, 2025, 14:41 ET — Regular session Axsome Therapeutics shares jumped 23% in afternoon trading on Wednesday after the company said U.S. regulators accepted its application and granted a faster review for AXS-05 to treat agitation in Alzheimer’s disease. GlobeNewswire The FDA’s acceptance puts a hard deadline on the next major catalyst for Axsome, with an April 30, 2026 decision target that brings clarity to the company’s regulatory timeline. The stock move also stood out against the broader biotech group, which was modestly higher. GlobeNewswire Axsome said the FDA granted “Priority Review,” meaning the agency’s goal is
31 December 2025
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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

Stock Performance and Recent Trend 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. Recent trading momentum: In the days leading up to Nov 3, AXSM shares climbed steadily, likely in anticipation of strong
3 November 2025

Stock Market Today

IREN stock heads into Monday after 5% rebound as Microsoft AI financing stays in focus

IREN stock heads into Monday after 5% rebound as Microsoft AI financing stays in focus

7 February 2026
IREN shares closed up 5.1% at $41.83 Friday after reporting a $155.4 million quarterly loss and $184.7 million in revenue. The company announced $3.6 billion in GPU financing for its Microsoft contract, with $2.8 billion in cash as of Jan. 31. Bitcoin mining revenue fell, while AI cloud services rose. Traders await bitcoin’s weekend move and Monday’s market reaction.
Cadence Bank stock is stuck at $42.11 after Huntington deal — what CADE holders watch next week

Cadence Bank stock is stuck at $42.11 after Huntington deal — what CADE holders watch next week

7 February 2026
Cadence Bank shares have been delisted following Huntington Bancshares’ takeover, with each Cadence share converted into 2.475 Huntington shares. Huntington closed Friday at $19.27 and named Senthil Kumar as chief risk officer ahead of new regulatory requirements. The merger leaves Cadence as a brand under Huntington, with customer account conversions planned for mid-2026. Huntington executives will address investors at a UBS conference on Tuesday.
NIO stock jumps on profit alert, with Monday’s open in focus

NIO stock jumps on profit alert, with Monday’s open in focus

7 February 2026
NIO shares jumped 7.23% to $5.04 Friday after the company forecast a swing to adjusted operating profit of up to 1.2 billion yuan for the fourth quarter. Trading volume reached 90.8 million shares, far above average. Nio’s deliveries rose 72% to 124,807 vehicles in the quarter. The company said results are preliminary and unaudited, with final figures due in March.
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