Welcome to our dedicated page for Axsome Therapeut news (Ticker: AXSM), a resource for investors and traders seeking the latest updates and insights on Axsome Therapeut stock.
Axsome Therapeutics, Inc. reports news on its biopharmaceutical business focused on central nervous system disorders, including marketed medicines and late-stage neuroscience programs. Company updates commonly cover FDA actions, product revenue for AUVELITY, SUNOSI and SYMBRAVO, business results, investor presentations, and development activity in neurological and psychiatric conditions.
Recurring topics include AUVELITY for major depressive disorder and agitation associated with dementia due to Alzheimer’s disease, SUNOSI for excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, migraine treatment commercialization, and pipeline work involving solriamfetol, AXS-12 and PDE10A inhibitor programs.
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.
Axsome Therapeutics announces an amendment to its term loan facility with Hercules Capital, increasing the loan size to $300 million. Upon potential FDA approval of AXS-05 for major depressive disorder, $100 million will be available immediately. The agreement extends the loan's maturity to October 2026 and interest-only payments up to 60 months. This capital will support the anticipated launches of both AXS-05 and AXS-07, enhancing financial flexibility for the company’s critical therapies.
Axsome Therapeutics, Inc. (NASDAQ: AXSM) has enrolled the first patient in the SYMPHONY trial, a Phase 3 study assessing AXS-12 for narcolepsy. This randomized, double-blind trial aims to evaluate AXS-12's efficacy and safety in about 90 patients, focusing on cataplexy attack frequency. Topline results are expected in early 2023. AXS-12, a selective norepinephrine reuptake inhibitor, has received Orphan Drug Designation from the FDA. The advancement into Phase 3 underscores Axsome's dedication to developing therapies for serious CNS disorders affecting patients' quality of life.