Axsome Therapeutics

Axsome Therapeutics, Inc. engages in the development of novel therapies for the management of central nervous system disorders. Its product candidates include AXS-05, AXS-07, AXS-12, and AXS-14 which are being developed for multiple pain and primary care indications. The company was founded by Herriot Tabuteau on January 12, 2012 and is headquartered in New York, NY.

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Axsome Therapeutics reports robust Q4 performance and eyes global expansion

Axsome Therapeutics had a strong Q4 2022, driven by successful commercialization of Auvelity and Sunosi.
While facing challenges such as legal disputes and payer coverage, the company is well-positioned for growth.
Strategic opportunities in expanding product portfolio and market access present avenues for future success.
Financially stable with a focus on innovation, Axsome is poised for continued growth and market expansion.

Axsome Therapeutics excels in Q1 2023 despite financial hurdles

Axsome Therapeutics demonstrated strong commercial and pipeline progress in Q1 2023, despite financial challenges.
The company's focus on expanding market share and optimizing commercial operations bodes well for future growth.
While facing challenges in sales guidance and NDA filings, Axsome's strong financial position and product performance offer opportunities for sustained success.

Axsome Therapeutics reports robust Q2 sales and expands product portfolio

Axsome Therapeutics demonstrated strong sales performance driven by Auvelity and Sunosi, with a focus on future growth potential.
Despite challenges such as increased costs and a net loss, the company is strategically expanding its product portfolio and market reach.
Opportunities lie in new FDA indications for existing products and the goal to have five marketed products by 2025.

Axsome Therapeutics reports robust Q3 earnings and outlines growth strategies

Axsome Therapeutics delivered strong revenue growth in Q3 2023, driven by Auvelity and Sunosi, showcasing a promising commercial outlook.
The company's pipeline progress and upcoming milestones reflect a commitment to innovation and expansion in the CNS therapeutic space.
While challenges like ongoing losses and strategic resource allocation persist, opportunities in new markets and product diversification offer avenues for future growth.

Axsome Therapeutics reports robust 2023 performance and eyes growth opportunities

Axsome Therapeutics had a strong financial performance in 2023, driven by the success of Auvelity and Sunosi. Despite challenges like increased expenses and net loss, opportunities for growth exist through new indications and expanded payer coverage.

Axsome Therapeutics excels in Q1 2024, poised for growth

Axsome Therapeutics demonstrated exceptional financial growth and pipeline advancements in Q1 2024, particularly in neuroscience programs like AXS-12.
Strong commercial performance of Auvelity and Sunosi, coupled with stable payer coverage and growth strategies, underpin the company's success trajectory.
While facing challenges related to study timelines and cybersecurity, Axsome Therapeutics remains poised to capitalize on upcoming milestones and market opportunities.

Axsome Therapeutics excels in Q2 2024, eyes market expansion

Axsome Therapeutics delivered a strong performance in Q2 2024, driven by revenue growth and progress on key product developments.
While facing challenges in market competition and operational execution, the company remains optimistic about future prospects.
Strategic opportunities in market expansion and product innovation position Axsome well for sustained growth and success in the CNS treatment space.

Axsome Therapeutics excels in Q3 with record revenue and pipeline progress

Axsome Therapeutics delivered a strong performance in Q3 2024, surpassing $100 million in quarterly product revenue and maintaining a solid financial position.
The company's strengths lie in its successful products, robust pipeline, and strategic commercial initiatives, supported by a strong cash reserve.
Challenges include managing expenses, navigating market dynamics, and sustaining commercial momentum, while opportunities exist in product launches and market expansion.
Overall, Axsome's performance reflects a balanced approach to growth, innovation, and market competitiveness, positioning the company for continued success.

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Axsome Therapeutics, Inc. is a commercial-stage biopharmaceutical company, which engages in the development of novel therapies for the management of central nervous system disorders. Its portfolio consists of Products Overview and Pipeline Overview. The Products Overview includes Auvelity and Sunosi. The Pipeline Overview contain AXS-05, AXS-07, AXS-12, and AXS-14. The company was founded by Herriot Tabuteau on January 12, 2012 and is headquartered in New York, NY.

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Rapid, durable, and statistically significant improvement demonstrated in patient-reported depressive symptoms, as measured by the QIDS-SR-16 total score compared to placebo (p=0.001)

Axsome Therapeutics Presents New Data from GEMINI Phase 3 Trial with AXS-05 Demonstrating Rapid and Significant Improvements in Patient-Reported Outcomes in Major Depressive Disorder

NEW YORK, Sept.  10, 2020  (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it will present clinical data on AXS-05 in the treatment of major depressive disorder (MDD) at the 33rd Congress of the European College of Neuropsychopharmacology (ECNP), to be held virtually, September 12-15. AXS-05 (dextromethorphan/bupropion modulated delivery tablet) is a novel, oral, investigational NMDA receptor antagonist and sigma-1 receptor agonist. The poster presentation will highlight new insights from the Phase 3 GEMINI trial.

Axsome Therapeutics to Present New Data for AXS-05 in Major Depressive Disorder at the 33rd European College of Neuropsychopharmacology Congress

Axsome (AXSM) reported earnings 30 days ago. What's next for the stock?

Axsome (AXSM) Down 10.4% Since Last Earnings Report: Can It Rebound?

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     Previously completed positive, pivotal ADVANCE-1 trial sufficient with single additional Phase 3 efficacy trial for NDA in Alzheimer’s disease agitation

Axsome Therapeutics Confirms Pivotal Status and Advancement of AXS-05 for the Treatment of Alzheimer’s Disease Agitation Based on Successful FDA Breakthrough Therapy Meeting

NEW YORK, Aug.  28, 2020  (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it will present efficacy and safety data from the CONCERT Phase 2 trial of AXS-12 in the treatment of narcolepsy at the 34th Annual SLEEP Meeting of the Associated Professional Sleep Societies (APSS). The meeting, which is a joint venture of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS), is being held virtually from August 27 to 30. AXS-12 is a novel, oral, highly selective and potent norepinephrine reuptake inhibitor for the treatment of narcolepsy. Details of the poster presentation are as follows:

Axsome Therapeutics to Present Data from the CONCERT Phase 2 Trial of AXS-12 in Narcolepsy at the SLEEP 2020 Annual Meeting

Axsome (AXSM) concludes a favorable pre-NDA meeting with the FDA for AXS-07, which is developed as an acute treatment of migraine. The company is on course to file the NDA in Q4.

Axsome's NDA Filing for Migraine Candidate in Q4 on Track

Axsome Therapeutics Completes Successful FDA Pre-NDA Meeting for AXS-07 for the Acute Treatment of Migraine

Axsome (AXSM) incurs a narrower loss in the second quarter of 2020. The company remains on track to submit the NDA for AXS-05 and AXS-07.

Axsome's (AXSM) Earnings Beat in Q2, Pipeline Progresses

The company announced that it is on track to submit two of its pipeline candidates to the FDA by year-end.

Why Axsome Therapeutics Stock Rose Today

Axsome Therapeutics, Inc. (AXSM) CEO Herriot Tabuteau on Q2 2020 Results - Earnings Call Transcript

Two NDA submissions, for AXS-05 in MDD and for AXS-07 in migraine, on track for 4Q 2020

Axsome Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update

Axsome Therapeutics: Big Unfolding Catalyst

Axsome to host conference call and webcast on Monday, August 10, 2020 at 8:00 AM Eastern Time

Axsome Therapeutics to Report Second Quarter 2020 Financial Results on August 10, 2020

The Secondary Impact Of COVID-19 Pandemic Leads To Bigger Market Potential For Axsome Therapeutics

Axsome (AXSM) concludes a favorable pre-NDA meeting with the FDA officials for AXS-05 to treat major depressive disorder. The company is on course to file the NDA in Q4.

Axsome's NDA for Depressive Disorder Drug on Track in Q420

Axsome Therapeutics Completes Successful FDA Pre-NDA Meeting for AXS-05 for the Treatment of Major Depressive Disorder

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The FDA bestows a Breakthrough Therapy status on Axsome's (AXSM) AXS-05 for the treatment of Alzheimer's disease agitation. Shares rise.

Axsome's AXS-05 Gets Breakthrough Therapy Tag for AD Agitation

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Designation offers potential for expedited development and review

Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-05 for the Treatment of Alzheimer’s Disease Agitation

Axsome is planning to submit NDAs later this year for its 2 leading indications.

Axsome Looks Extremely Undervalued After Recent Share Price Decline

Why Is Axsome (AXSM) Down 15.7% Since Last Earnings Report?

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News for Axsome Therapeutics Stock (AXSM)