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The Latest Breaking News from Axsome

BridgeBio, ARS Pharma, Harmony Bio Shine At JPM. But SpringWorks, Beam Take Their Lumps.

Biotech stocks put up a split showing at JPM, where names like BridgeBio, ARS and Harmony stood out with strong preliminary reports.

Investors Business Daily

Axsome Flashes A Bearish Signal On Mixed Results In Alzheimer's Agitation

Shares of Axsome Therapeutics dropped Monday on mixed test results for its Alzheimer's disease agitation treatment.

Investors Business Daily

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.

Benzinga

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Axsome Dips On Wide Losses, But Its Biggest Moneymaker Tacks On 135% Growth

Axsome stock fell Monday after the company posted wider-than-expected losses, though second-quarter sales depression drug beat most views.

Investors Business Daily

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

Axsome Tumbles On An Unexpected Setback For Its Alzheimer's Drug

Axsome reported strong fourth-quarter sales Tuesday, but AXSM stock tumbled on a setback for the company's Alzheimer's agitation treatment.

Investors Business Daily

Axsome Therapeutics Expects Up To $11.5 Billion In Peak Sales, Wallops Analysts' Forecasts

Axsome expects its eight products to generate up to $11.5 billion in peak U.S. sales. AXSM stock zoomed higher Wednesday.

Investors Business Daily

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Market Rally Diverges; Google Surges On AI News, Inflation Cools, But Breadth Weak: Weekly Review

The Nasdaq hit a 2023 high as Google soared on AI announcements. But the market rally showed weakness too.

Investors Business Daily

Highly Rated Axsome Surges On Earnings Beat. And Here's Why BioXcel Reversed.

Axsome and BioXcel issued divergent earnings reports Monday, but BTAI stock reversed an earlier dive and rose alongside AXSM stock.

Investors Business Daily

Teva Plots Its Knockoff Of Axsome's New Depression Drug, Sending The Biotech Sprawling

Teva Pharmaceutical said Monday it plans to make a knockoff of Axsome Therapeutics' new depression treatment, leading AXSM stock to tumble.

Investors Business Daily

Axsome Hits The Stratosphere On Alzheimer's News As Biogen Faces A Setback

Axsome Therapeutics said its Alzheimer's treatment met the goals of a study, sending its shares into the stratosphere, while Biogen's Alzheimer's effort had a setback.

Investors Business Daily

Relmada Tanks After 'Paradoxical Results' Undermine Depression Drug; Axsome Surges

Relmada stock crashed Thursday after its depression treatment failed a final-phase test, helping bolster rival Axsome. AXSM stock surged.

Investors Business Daily

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…

Benzinga

15 Biotech Stocks That Hit Year Highs Over The Last Week, Including Sarepta, Axsome

In recent days, biotech stocks have slowed their early-August sprint. But not all shares are ready to hit the showers.

Investors Business Daily

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Investors Business Daily

Axsome Wins A 60-Year First In Depression; And Shares Catapult 40%

The Food and Drug Administration approved a new depression pill from Axsome Therapeutics on Friday, and AXSM stock catapulted higher.

Benzinga

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.

Investors Business Daily

Axsome Therapeutics Just Took Its Key Moving Averages — Here's Why

The Food and Drug Administration could be nearing a decision on Axsome Therapeutics' depression treatment, and AXSM stock rocketed Monday.

Benzinga

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).

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Benzinga

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…

Benzinga

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…

Investors Business Daily

Axsome Therapeutics' Good Fortune Reverses As Its Migraine Drug Hits A Hurdle

Axsome Therapeutics expects the Food and Drug Administration to reject its migraine treatment, leading AXSM stock to crumble on Monday.

Investors Business Daily

Axsome Therapeutics Stock Rockets As Its First FDA Approval Looks Imminent

Axsome Therapeutics said Tuesday it agreed to the FDA's requirements for approving its depression drug, and AXSM stock rocketed.

Benzinga

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.

Benzinga

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).

Benzinga

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:

1 2

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