Welcome to our dedicated page for Axsome Therapeutics news (Ticker: AXSM), a resource for investors and traders seeking the latest updates and insights on Axsome Therapeutics stock.
Axsome Therapeutics, Inc. (NASDAQ: AXSM) is a leading biopharmaceutical company dedicated to developing innovative therapies for the treatment of central nervous system (CNS) disorders. Headquartered in New York City, Axsome's mission is to address unmet medical needs and improve the lives of patients suffering from CNS conditions.
The company's portfolio includes a mix of clinical-stage and research-stage product candidates, with a primary focus on CNS disorders such as depression, migraine, narcolepsy, and Alzheimer's disease. Axsome's pipeline features notable candidates like AXS-05 for major depressive disorder, AXS-07 for migraine, AXS-12 for narcolepsy, and AXS-14 for fibromyalgia. These therapies are being developed to provide novel treatment options where current solutions are limited or inadequate.
Axsome manages its business as a single operating segment, emphasizing the development and delivery of groundbreaking CNS therapies. The company has made significant strides in advancing its clinical programs, with several candidates progressing through various stages of clinical trials. Recent achievements include positive data readouts from clinical studies and successful end-of-phase meetings with regulatory bodies, positioning Axsome closer to potential market approvals.
Financially, Axsome maintains a solid foundation through strategic collaborations, public offerings, and partnerships. These financial maneuvers have enabled sustained investment in research and development, essential for driving innovation and bringing new therapies to market.
Axsome's commitment to transforming the treatment landscape for CNS disorders is underscored by its active engagement with the medical community, participation in scientific conferences, and continuous updates to investors and stakeholders. The company’s proactive communication strategy ensures transparency and keeps all interested parties informed about ongoing developments.
For the latest updates, investors and media can reach out to Mark Jacobson, Chief Operating Officer, or Darren Opland, Director of Corporate Communications, at Axsome's headquarters in New York City. More information is available on the company’s website, www.axsome.com.
Axsome Therapeutics (NASDAQ: AXSM) announced that the FDA has accepted the resubmission of its New Drug Application (NDA) for AXS-07, a treatment for acute migraine. The FDA has classified it as a Class 2 resubmission and set a PDUFA action goal date of January 31, 2025. This development marks a significant milestone in Axsome's efforts to bring a new migraine treatment to market. The acceptance of the NDA resubmission indicates progress in addressing previous FDA concerns and moves AXS-07 closer to potential approval. Investors and patients alike will be closely watching the outcome, as a successful approval could impact both Axsome's market position and migraine treatment options.
Axsome Therapeutics (NASDAQ: AXSM), a biopharmaceutical company focused on central nervous system (CNS) disorders, has announced its participation in four major investor conferences in September 2024:
1. Morgan Stanley 22nd Annual Global Healthcare Conference on September 4 in New York (presentation at 4:50 p.m. ET)
2. Wells Fargo Healthcare Conference on September 5 in Boston (investor meetings)
3. Baird 2024 Global Healthcare Conference on September 11 in New York (presentation at 8:30 a.m. ET)
4. Cantor Global Healthcare Conference on September 18 in New York (presentation at 9:45 a.m. ET)
Live webcasts of the presentations at the Morgan Stanley and Cantor conferences will be available on Axsome's website, with replays accessible for approximately 30 days after each event.
Axsome Therapeutics (NASDAQ: AXSM) has announced an agreement with Sandoz Inc. to dismiss the patent litigation related to Axsome's product Sunosi® (solriamfetol). The litigation was pending in the U.S. District Court for the District of New Jersey and stemmed from Sandoz's submission of an Abbreviated New Drug Application (ANDA) to the FDA, seeking approval to market a generic equivalent of Sunosi in the United States. As part of the agreement, Sandoz has withdrawn its ANDA for a generic equivalent of Sunosi, resulting in the dismissal of the litigation without prejudice.
Axsome Therapeutics (NASDAQ: AXSM) reported strong Q2 2024 financial results, with total net product revenue of $87.2 million, up 87% year-over-year. Auvelity sales grew 135% to $65.0 million, while Sunosi revenue increased 16% to $22.1 million. The company resubmitted its NDA for AXS-07 in migraine and expects to submit an NDA for AXS-14 in fibromyalgia in Q3 2024. Axsome anticipates topline results from multiple Phase 3 trials in H2 2024, including studies of AXS-05 in Alzheimer's disease agitation and solriamfetol in ADHD. Despite strong revenue growth, the company reported a net loss of $79.3 million for Q2 2024, compared to $67.2 million in Q2 2023, primarily due to increased R&D and SG&A expenses.
Axsome Therapeutics (NASDAQ: AXSM), a leading biopharmaceutical company specializing in CNS disorder treatments, announced it will report its Q2 2024 financial results on August 5, 2024, before U.S. markets open. The management will host a conference call at 8:00 a.m. ET to discuss the results and provide a business update. Investors can join the call via a toll-free number or access a live webcast through the company's website. A recording will be available for 30 days post-event.
Axsome Therapeutics (NASDAQ: AXSM) announced a settlement with Unichem Laboratories regarding patent litigation for Sunosi® (solriamfetol). The litigation arose after Unichem filed for FDA approval to market a generic version of Sunosi in the U.S. per an Abbreviated New Drug Application. The settlement allows Unichem to sell its generic version starting June 30, 2042, with possible earlier entry under specific conditions. Additionally, the date could be extended for pediatric exclusivity. The agreement will be reviewed by the U.S. Federal Trade Commission and the Department of Justice. Similar litigation with other parties continues in the District of New Jersey.
Axsome Therapeutics (NASDAQ: AXSM) announced its participation in the American Migraine Foundation's efforts for Migraine & Headache Awareness Month in June 2024. This initiative aims to raise awareness about unmet treatment needs for the 37 million Americans suffering from migraines, which cause significant physical, emotional, and economic impacts. The American Migraine Foundation emphasizes the importance of education, support, community, and research to improve patient outcomes and societal attitudes toward migraines. Notably, 70% of migraine sufferers are dissatisfied with current treatments, and nearly 80% are open to trying new therapies.
Axsome Therapeutics (NASDAQ: AXSM), a biopharmaceutical company specializing in central nervous system (CNS) disorders, announced its support for Alzheimer’s & Brain Awareness Month this June. The initiative aims to raise awareness about Alzheimer’s disease (AD), a progressive neurodegenerative disorder affecting nearly 7 million individuals in the U.S., a number that could double by 2060. Axsome's headquarters at One World Trade Center will be illuminated in purple on June 21, 2024, symbolizing AD awareness.
Axsome Therapeutics (NASDAQ: AXSM), a biopharmaceutical company specializing in therapies for CNS disorders, announced participation in two investor conferences. These events include the William Blair 44th Annual Growth Stock Conference on June 5 in Chicago, where CEO Herriot Tabuteau, MD, will present a corporate overview, and the Goldman Sachs 45th Annual Global Healthcare Conference on June 12 in Miami Beach, where Axsome leadership will conduct investor meetings. A live webcast of the William Blair presentation will be available on the company's website.
On May 29, 2024, Axsome Therapeutics (NASDAQ: AXSM) announced significant findings on solriamfetol at the SLEEP 2024 conference, held from June 1-5, 2024, in Houston, Texas. The presentations highlighted solriamfetol's positive effects on cognitive function in patients with Obstructive Sleep Apnea (OSA) and narcolepsy, particularly those experiencing Excessive Daytime Sleepiness (EDS). Key findings from the SHARP study, led by Professor Hans Van Dongen, demonstrated improvements in executive function, memory, and processing speed. Presentations included two oral plenary sessions and multiple poster sessions, emphasizing solriamfetol's impact on various cognitive metrics and real-world applications.
FAQ
What is the current stock price of Axsome Therapeutics (AXSM)?
What is the market cap of Axsome Therapeutics (AXSM)?
What does Axsome Therapeutics, Inc. do?
Where is Axsome Therapeutics based?
What are some key products in Axsome's pipeline?
What recent achievements has Axsome made?
How does Axsome manage its business operations?
How does Axsome maintain its financial health?
Who are the key contacts for investors and media?
What is the mission of Axsome Therapeutics?
What kind of disorders does Axsome focus on?
How can I stay updated on Axsome's latest news and developments?
