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.

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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.

Needham initiated coverage on Axsome Therapeutics Inc AXSM, which focuses on central nervous disorders conditions, including depression, Alzheimer's disease agitation, migraine, narcolepsy, and fibromyalgia.

Axsome Therapeutics' CNS Portfolio Poised for Major Growth - Analyst Predicts Strong Future

The mean of analysts' price targets for Axsome (AXSM) points to a 49.4% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Wall Street Analysts Predict a 49.36% Upside in Axsome (AXSM): Here's What You Should Know

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Axsome Therapeutics was recently the target of an activist short seller. The allegations will impact the biotech's financials if they are true.

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NEW YORK, June 05, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM) (Axsome), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today announced that it has entered into a settlement agreement with Unichem Laboratories Ltd. (Unichem) resolving patent litigation related to Axsome's product Sunosi® (solriamfetol). The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submission by Unichem of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. The settlement agreement permits Unichem to begin selling its generic version of Sunosi on June 30, 2042, or earlier under certain circumstances. The June 30, 2042 date is also subject to potential extension for pediatric exclusivity.

Axsome Therapeutics Settles Sunosi® (solriamfetol) Patent Litigation with Unichem Laboratories

NEW YORK, June 04, 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 today it is joining the migraine advocacy community to raise awareness of unmet patient needs during Migraine & Headache Awareness Month this June.

Axsome Therapeutics Joins the American Migraine Foundation to Highlight Unmet Treatment Needs During Migraine & Headache Awareness Month

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NEW YORK, May 29, 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 five presentations, including two featured oral plenary presentations, on solriamfetol at SLEEP 2024, the 38th annual meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS), being held June 1-5, 2024, in Houston, Texas. “Cognitive functioning is an underappreciated facet of sleep disorders.

Axsome Therapeutics Highlights Data on Solriamfetol Demonstrating Improvement in Cognitive Function in Patients with Obstructive Sleep Apnea or Narcolepsy at SLEEP 2024

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Axsome Therapeutics develops treatments for CNS conditions, with two commercial products: Auvelity for major depressive disorders and Sunosi for sleep disorders. The company has a diverse pipeline targeting illnesses such as Alzheimer's disease, smoking cessation, migraine, narcolepsy, and more. Axsome's portfolio addresses the medical needs of over 150 million people and has the potential to generate peak sales of up to $16.5 billion.

Why Axsome Therapeutics Is A Promising Stock Pick In CNS Treatments

NEW YORK, May 08, 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 two upcoming investor conferences.

Axsome Therapeutics to Present at Upcoming Investor Conferences

Axsome's (AXSM) bottom line declines year over year in the first quarter. Strong sales of Auvelity drive revenues.

Axsome (AXSM) Q1 Loss Widens Y/Y, Revenues Beat Estimates

Axsome Therapeutics, Inc. (NASDAQ:AXSM ) Q1 2024 Earnings Conference Call May 6, 2024 8:00 AM ET Company Participants Darren Opland - Director, Corporate Communications Herriot Tabuteau - Chief Executive Officer Nick Pizzie - Chief Financial Officer Ari Maizel - Executive Vice President & Head, Commercial Mark Jacobson - Chief Operating Officer Conference Call Participants Charles Duncan - Cantor Fitzgerald Leonid Timashev - RBC Capital Markets Ash Verma - UBS Ram Selvaraju - H.C. Wainwright Marc Goodman - Leerink Partners David Amsellem - Piper Sandler Yatin Suneja - Guggenheim Partners Jason Gerberry - Bank of America Joon Lee - Truist Securities Joel Beatty - Baird David Hoang - Citi Vikram Purohit - Morgan Stanley Matt Kaplan - Ladenburg Thalmann Myles Minter - William Blair Troy Langford - TD Cowen Operator Good morning, and welcome to the Axsome Therapeutics Conference Call.

Axsome Therapeutics, Inc. (AXSM) Q1 2024 Earnings Call Transcript

Total 1Q 2024 net product revenue of $75.0 million, representing 160% year-over-year growth Auvelity® 1Q 2024 net product sales of $53.4 million, representing 240% year-over-year growth Sunosi® 1Q 2024 net product revenue of $21.6 million representing 64% year-over-year growth Contract executed with second large group purchasing organization (GPO) for potential coverage of Auvelity Positive pivotal Phase 3 trial results of AXS-12 in narcolepsy announced Topline results of ADVANCE-2 Phase 3 trial of AXS-05 in Alzheimer's disease agitation and FOCUS Phase 3 trial of solriamfetol in ADHD both anticipated 2H 2024 ACCORD-2 Phase 3 randomized withdrawal trial of AXS-05 in Alzheimer's disease agitation initiated; enrollment completion anticipated mid-year 2024 PARADIGM and ENGAGE Phase 3 trials of solriamfetol in major depressive disorder and binge eating disorder, respectively, initiated NDA resubmission for AXS-07 in migraine and NDA submission for AXS-14 in fibromyalgia both targeted for 2Q 2024 NEW YORK, May 06, 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 financial results for the first quarter of 2024. “The first quarter was marked by strong financial performance for our on-market products which are delivering important and differentiated treatment options for patients living with depression, narcolepsy and obstructive sleep apnea,” said Herriot Tabuteau, MD, CEO of Axsome Therapeutics.

Axsome Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update

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

Should You Buy Axsome Therapeutics (AXSM) Ahead of Earnings?

NEW YORK, May 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, today is joining the global community of mental health advocates, including Mental Health America, during May's Mental Health Month to raise awareness of the importance of mental health as a key element of overall health.

Axsome Therapeutics Recognizes May as Mental Health Awareness Month

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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.

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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

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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.

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