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 a Complete Response Letter (CRL) from the FDA regarding its NDA for AXS-07, aimed at treating acute migraines. The CRL raised no efficacy or safety concerns but identified the need for additional chemistry, manufacturing, and controls (CMC) data. Axsome plans to engage with the FDA to resolve these outstanding items and aims to resubmit its application promptly. AXS-07 is supported by positive Phase 3 trial results demonstrating significant migraine pain relief.
Axsome Therapeutics (NASDAQ: AXSM) plans to announce its first-quarter 2022 financial results on May 2, 2022, prior to market opening. The company will host a conference call at 8:00 AM ET on the same day to discuss the results and provide a business update. As a biopharmaceutical company, Axsome focuses on developing innovative therapies for central nervous system disorders, aiming to significantly improve patient outcomes.
Axsome Therapeutics has announced its acquisition of Sunosi from Jazz Pharmaceuticals, a strategic move set to bolster Axsome's global commercial presence.
Sunosi is a FDA-approved dual-acting dopamine and norepinephrine reuptake inhibitor aimed at improving wakefulness in adults suffering from excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea.
The transaction, valued at $53 million, is expected to be breakeven in 2023 and could generate over $1 billion in peak revenues, enhancing Axsome's pipeline ahead of potential launches of AXS-05 and AXS-07.
Axsome Therapeutics, Inc. (NASDAQ: AXSM) announced that CEO Herriot Tabuteau will participate in a virtual fireside chat at the 1st Annual Needham Virtual Neuroscience Forum on March 16, 2022, at 10:15 AM ET. Interested parties can access a live webcast on the company’s website. Axsome focuses on developing therapies for central nervous system (CNS) disorders with limited treatment options, aiming to improve patient lives and provide new options for physicians.
Axsome Therapeutics (NASDAQ: AXSM) announced that CEO Herriot Tabuteau will participate in a virtual fireside chat at the Cowen 42nd Annual Health Care Conference on March 7, 2022, at 10:30 AM Eastern Time. A live webcast and archive will be available on the Company’s website. Axsome focuses on developing innovative therapies for central nervous system disorders, aiming to improve treatment options for patients. The Company is committed to transforming CNS treatment through its novel mechanisms of action.
Axsome Therapeutics (NASDAQ: AXSM) announced its fourth-quarter and full-year financial results for 2021, highlighting a net loss of $34 million, or $(0.90) per share, compared to a loss of $29.2 million, or $(0.78) per share, in Q4 2020. R&D expenses decreased to $13.8 million, attributed to the conclusion of clinical trials. The company is advancing its pipeline, with NDAs for AXS-05 for major depressive disorder and AXS-07 for migraines under FDA review, with a PDUFA date of April 30, 2022. Axsome ended 2021 with $86.5 million in cash, having accessed $20 million from its ATM equity facility in February 2022.
Axsome Therapeutics (NASDAQ: AXSM) will report its Q4 and fiscal year 2021 financial results on March 1, 2022, before U.S. market opening. A conference call is scheduled for 8:00 AM ET on the same day to discuss these results and provide a business update. The event can be accessed via a live webcast on the company’s website. Axsome is focused on developing novel therapies for central nervous system disorders. The press release includes forward-looking statements regarding clinical trial outcomes and regulatory approvals, highlighting potential risks and uncertainties.
Axsome Therapeutics (NASDAQ: AXSM) announced that CEO Herriot Tabuteau will engage in a virtual fireside chat during the 11th Annual SVB Leerink Global Healthcare Conference on February 16, 2022, at 1:40 PM ET. The event will focus on the company’s innovative therapies for central nervous system disorders. A live webcast and archive will be available on the company’s website. Axsome is dedicated to developing unique treatment options to enhance patient care, targeting conditions with limited therapies.
Axsome Therapeutics reported its third quarter 2021 financial results, highlighting the advancement of its CNS products. The FDA is currently reviewing the NDA for AXS-05 in depression, while the NDA for AXS-07 in migraine has been accepted. The company is preparing for potential launches if approved. Axsome's R&D expenses decreased to $13.2 million, while G&A expenses spiked to $20.2 million, reflecting pre-commercial activities. The net loss rose to $34.9 million. Cash reserves stand at $114.6 million, sufficient to fund operations through 2024.
Axsome Therapeutics (NASDAQ: AXSM) will report its Q3 2021 financial results on November 8, 2021, prior to market opening. A conference call will follow at 8:00 AM ET the same day, aimed at discussing these results along with a business update. Interested participants can join by dialing (844) 698-4029 (domestic) or (647) 253-8660 (international), using conference ID 6365926. The event will also be available via a live webcast on the Company's website, with a recording accessible for 30 days post-event.
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