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.

Axsome (AXSM) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Earnings Preview: Axsome Therapeutics (AXSM) Q1 Earnings Expected to Decline

AXS-05 in Alzheimer's disease agitation data featured in oral plenary session New data for AXS-07 in migraine demonstrating efficacy in pooled analysis Presentations on cognitive and wake promoting effects of solriamfetol NEW YORK, April 15, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced presentations highlighting its innovative psychiatry and neurology pipeline at the American Academy of Neurology (AAN) 2024 annual meeting, being held April 13-18, 2024, in Denver, Colorado. The presentations include an oral presentation during the Clinical Trials Plenary Session of data from the ACCORD Phase 3 trial of AXS-05 in Alzheimer's disease agitation (ADA).

Axsome Therapeutics Highlights Innovative Neuroscience Portfolio at the American Academy of Neurology (AAN) 2024 Annual Meeting

Madrigal Pharmaceuticals

Madrigal Pharmaceuticals recently earned a groundbreaking therapy approval. Axsome Therapeutics is getting closer to transforming its lineup of medicines.

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NEW YORK, April 10, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced it will report its financial results for the first quarter of 2024 on Monday, May 6, 2024, before the opening of the U.S. financial markets. Axsome's management team will host a conference call at 8:00 a.m. Eastern Time on May 6, 2024, to discuss these results and provide a business update.

Axsome Therapeutics to Report First Quarter 2024 Financial Results on May 6

Axsome's (AXSM) phase III ENGAGE study is set to evaluate the efficacy and safety of solriamfetol for the treatment of binge eating disorder in adults.

Axsome (AXSM) Begins Solriamfetol Binge Eating Phase III Study

NEW YORK, April 01, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, announced the initiation of the ENGAGE Phase 3 trial of solriamfetol, an investigational treatment for binge eating disorder (BED) in adults.

Axsome Therapeutics Initiates ENGAGE Phase 3 Trial of Solriamfetol for the Treatment of Binge Eating Disorder

Catalyst Pharmaceuticals

Krystal Biotech

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Data from a late-stage study shows that a five-week treatment with Axsome's (AXSM) experimental narcolepsy drug reduced weekly cataplexy attacks by 83%, compared to 66% for placebo.

Axsome's (AXSM) Narcolepsy Drug Study Meets Primary Goal

77% of narcolepsy type 1 patients continue to experience cataplexy attacks despite being treated 64% of narcolepsy type 1 patients continue to experience excessive daytime sleepiness, as assessed by the Epworth Sleepiness Scale (ESS), despite being treated 74% of treated narcolepsy type 1 patients exhibit cognitive impairment, as assessed by the British Columbia Cognitive Complaints Inventory (BC-CCI) Depression and anxiety were experienced by 45% and 57% of narcolepsy type 1 patients, respectively NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced topline results from the CRESCENDO (Characterizing Patient Perspectives on Unmet Needs in Narcolepsy) survey of patients with narcolepsy type 1 (NT1, i.e., narcolepsy with cataplexy) receiving treatment, demonstrating high rates of persistent symptoms and significant patient burden, despite being on current treatments.

Axsome Therapeutics Announces Results of CRESCENDO Narcolepsy Patient Survey Demonstrating Unmet Needs in Treated Narcolepsy Type 1 Patients

Axsome Therapeutics said on Monday its therapy for a sleep disorder met the main goal of a late-stage study.

Axsome Therapeutics sleep disorder therapy succeeds in late-stage trial

AXS-12 statistically significantly reduced cataplexy attacks compared to placebo (p=0.018, primary endpoint) AXS-12 achieved statistically significant remission of cataplexy compared to placebo (p=0.008) AXS-12 statistically significantly reduced excessive daytime sleepiness (EDS) severity compared to placebo (p=0.027, CGI-S for EDS) AXS-12 statistically significantly improved concentration and memory compared to placebo (p=0.004, Cognitive Function items of FOSQ-10) AXS-12 statistically significantly reduced overall severity of narcolepsy compared to placebo (p=0.007, CGI-S for narcolepsy) AXS-12 statistically significantly improved overall function and quality of life compared to placebo (p=0.005, FOSQ-10 total score) Company to host conference call and webcast today at 8:00 AM ET NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that AXS-12 (reboxetine), a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator, achieved the primary endpoint and significantly reduced the frequency of cataplexy attacks as compared to placebo in patients with narcolepsy in the SYMPHONY Phase 3 trial. AXS-12 also reduced excessive daytime sleepiness (EDS) severity, improved cognitive function, and reduced overall narcolepsy severity as compared to placebo.

Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in the SYMPHONY Phase 3 Trial in Narcolepsy

CRISPR Therapeutics

Pfizer

Many investors appear to be underestimating Axsome Therapeutics. CRISPR Therapeutics has tremendous long-term prospects.

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

Why Is Axsome (AXSM) Down 4% Since Last Earnings Report?

Axsome (AXSM) doses the first patient in the phase III PARADIGM study evaluating Sunosi (solriamfetol) for treating major depressive disorder. The stock rises 6%.

Axsome (AXSM) Begins Dosing in Depression Study on Sunosi

NEW YORK, March 19, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the first patient has been dosed in the PARADIGM Phase 3 trial of solriamfetol, an investigational treatment for major depressive disorder (MDD).

Axsome Therapeutics Initiates PARADIGM Phase 3 Trial of Solriamfetol for the Treatment of Major Depressive Disorder

NEW YORK, March 05, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome's Chief Executive Officer, will participate in a fireside chat at the Leerink Partners Global Biopharma Conference on Wednesday, March 13, at 9:20 a.m. Eastern Time at the Fontainebleau in Miami Beach, Florida.

Axsome Therapeutics to Present at the Leerink Partners Global Biopharma Conference

NEW YORK, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome's Chief Executive Officer, will participate in a fireside chat at the TD Cowen 44th Annual Healthcare Conference on Wednesday, March 6, from 9:50-10:20 a.m. Eastern Time at the Marriott Copley Place in Boston, Massachusetts.

Axsome Therapeutics to Present at the TD Cowen 44th Annual Healthcare Conference

Immunovant Inc

Iovance Biotherapeutics

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Amgen

CRISPR Therapeutics' recent major regulatory win could be the first of many. Axsome Therapeutics should ride the wave from its rich late-stage pipeline.

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Axsome (AXSM) stock declines despite narrower-than-expected loss in the fourth quarter of 2023. Its sales also beat estimates.

Axsome (AXSM) Stock Falls Despite Q4 Earnings & Revenue Beat

Axsome Therapeutics, Inc. (AXSM) Q4 2023 Earnings Call Transcript

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

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

Axsome Therapeutics (AXSM) came out with a quarterly loss of $0.73 per share versus the Zacks Consensus Estimate of a loss of $1.21. This compares to loss of $1.28 per share a year ago.

Axsome Therapeutics (AXSM) Reports Q4 Loss, Tops Revenue Estimates

Total 4Q and full year 2023 net product revenue of $71.5 million and $204.9 million, respectively, representing year-over-year growth of 193% and 309%

Axsome Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Axsome (AXSM) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

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