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The Latest Breaking News from Axsome

Biotech Is Heating Up—These 2 Red-Hot Stocks Stand Out

Significant updates from the FDA toward the end of 2025 have rallied investor interest in Axsome and Innoviva, two high-potential biotech names for 2026.

Axsome Therapeutics Analysts Increase Their Forecasts After Q2 Earnings

Axsome Therapeutics Analysts Increase Their Forecasts After Q2 Earnings

Axsome Therapeutics, Inc. (NASDAQ:AXSM) reported better-than-expected second-quarter financial results on Monday.

2 Growth Stocks Wall Street Predicts Will Soar 74% to 159%

2 Growth Stocks Wall Street Predicts Will Soar 74% to 159%

With a strong pipeline, these two biotechs are poised for explosive growth.

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This Little-Known Stock Could Be One of the Best Recession-Proof Investments Now

RBC flags this biopharma stock as recession-ready, with stellar upside potential hiding in plain sight.

Axsome Therapeutics' AXS-12 Data For Sleeping Disorder Boosts Confidence In Approval And Market Potential, Analyst Says

Axsome's AXS-12 met Phase 3 trial goals, cutting cataplexy attacks by 77% over six months and improving cognition with a favorable safety profile.

Can psychedelics treat depression? Maybe, and you might not even have to take a trip

The use of the drugs in treating low mood has sparked debate, not least about the necessity of a hallucinogenic experience. But a new discovery may provide an answer

The Guardian - UK

Recap Of Thursday's Biotech Catalysts - End Of the Day Summary

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Intellia Therapeutics’ (NASDAQ:NTLA) lead asset NTLA-2002, for the treatment of hereditary angioedema (HAE). Intellia shares traded in a range of $56.52 to $60.06 on day volume of 901.43 thousand shares, closed regular trading session at $59.97. The company…

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What SVB Says On Axsome's Strategy Review On Sunosi For Sleeping Disorder

What SVB Says On Axsome's Strategy Review On Sunosi For Sleeping Disorder

Axsome Therapeutics Inc (NASDAQ: AXSM) held an investor event to review its strategy with Sunosi, which is indicated for excessive daytime sleepiness (EDS) in narcolepsy and obstructive sleep apnea (OSA). SVB Leerink says its view on Sunosi has not changed.

Axsome Therapeutics Rallies 40% On FDA Product Label Proposal, But Analyst Remains Skeptical

Axsome Therapeutics Rallies 40% On FDA Product Label Proposal, But Analyst Remains Skeptical

Axsome Therapeutics Inc (NASDAQ: AXSM) shares rallied 40% on Monday morning after the company received some positive news from the U.S. Food and Drug Administration regarding its AXS-05 novel treatment for MDD (depression).

As Expected, FDA Rejects Axsome Therapeutics' Migraine Candidate

As Expected, FDA Rejects Axsome Therapeutics' Migraine Candidate

The FDA has issued a Complete Response Letter (CRL) to Axsome Therapeutics Inc's (NASDAQ:AXSM) AXS-07 for the acute treatment of migraine. The CRL did not identify or raise any concerns about the clinical efficacy or safety data in the NDA, and the FDA did not request any new clinical trials to support the approval…

Axsome Poised To Receive FDA Rejection For Its Migraine Candidate, Shares Fall

Axsome Poised To Receive FDA Rejection For Its Migraine Candidate, Shares Fall

The FDA has informed that Axsome Therapeutics Inc (NASDAQ:AXSM) chemistry, manufacturing, and controls issues identified during the review of AXS-07 remain unresolved. The Company is seeking approval for AXS-07 for the acute treatment of migraine. Based on the time remaining in the review cycle, the Company expects to receive a Complete Response Letter…

Axsome Therapeutics Stock Is Surging: Here's Why

Axsome Therapeutics Stock Is Surging: Here's Why

Axsome Therapeutics Inc (NASDAQ: AXSM) shares are trading higher Tuesday after the company announced it received and agreed to Postmarketing Requirements/Commitments proposed by the U.S. Food and Drug Administration with respect to the New Drug Application (NDA) for its AXS-05.

Why Axsome Therapeutics Stock Is Trading Higher

Why Axsome Therapeutics Stock Is Trading Higher

Axsome Therapeutics Inc (NASDAQ: AXSM) is trading higher Monday morning after the company announced it will acquire Sunosi from Jazz Therapeutics PLC (NASDAQ: JAZZ).

The Daily Biotech Pulse: Pfizer, Amgen Shares Slip On Earnings, Editas Terminates Chief Medical Officer, Biogen Licenses Preclinical Rheumatoid Arthritis Biosimilar

The Daily Biotech Pulse: Pfizer, Amgen Shares Slip On Earnings, Editas Terminates Chief Medical Officer, Biogen Licenses Preclinical Rheumatoid Arthritis Biosimilar

Here's a roundup of top developments in the biotech space over the last 24 hours:

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Stock Wars: Axsome Therapeutics Vs. Global Blood Therapeutics

Benzinga’s weekly Stock Wars matches up two leaders in a major industry sector with the goal of determining which company is the better investment.

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